Publications by authors named "Gregory S Merrick"

180 Publications

Comparison of Multimodal Therapies and Outcomes Among Patients With High-Risk Prostate Cancer With Adverse Clinicopathologic Features.

JAMA Netw Open 2021 Jul 1;4(7):e2115312. Epub 2021 Jul 1.

Department of Urology, Brady Urological Institute, Johns Hopkins University, Baltimore, Maryland.

Importance: The optimal management strategy for high-risk prostate cancer and additional adverse clinicopathologic features remains unknown.

Objective: To compare clinical outcomes among patients with high-risk prostate cancer after definitive treatment.

Design, Setting, And Participants: This retrospective cohort study included patients with high-risk prostate cancer (as defined by the National Comprehensive Cancer Network [NCCN]) and at least 1 adverse clinicopathologic feature (defined as any primary Gleason pattern 5 on biopsy, clinical T3b-4 disease, ≥50% cores with biopsy results positive for prostate cancer, or NCCN ≥2 high-risk features) treated between 2000 and 2014 at 16 tertiary centers. Data were analyzed in November 2020.

Exposures: Radical prostatectomy (RP), external beam radiotherapy (EBRT) with androgen deprivation therapy (ADT), or EBRT plus brachytherapy boost (BT) with ADT. Guideline-concordant multimodal treatment was defined as RP with appropriate use of multimodal therapy (optimal RP), EBRT with at least 2 years of ADT (optimal EBRT), or EBRT with BT with at least 1 year ADT (optimal EBRT with BT).

Main Outcomes And Measures: The primary outcome was prostate cancer-specific mortality; distant metastasis was a secondary outcome. Differences were evaluated using inverse probability of treatment weight-adjusted Fine-Gray competing risk regression models.

Results: A total of 6004 men (median [interquartile range] age, 66.4 [60.9-71.8] years) with high-risk prostate cancer were analyzed, including 3175 patients (52.9%) who underwent RP, 1830 patients (30.5%) who underwent EBRT alone, and 999 patients (16.6%) who underwent EBRT with BT. Compared with RP, treatment with EBRT with BT (subdistribution hazard ratio [sHR] 0.78, [95% CI, 0.63-0.97]; P = .03) or with EBRT alone (sHR, 0.70 [95% CI, 0.53-0.92]; P = .01) was associated with significantly improved prostate cancer-specific mortality; there was no difference in prostate cancer-specific mortality between EBRT with BT and EBRT alone (sHR, 0.89 [95% CI, 0.67-1.18]; P = .43). No significant differences in prostate cancer-specific mortality were found across treatment cohorts among 2940 patients who received guideline-concordant multimodality treatment (eg, optimal EBRT alone vs optimal RP: sHR, 0.76 [95% CI, 0.52-1.09]; P = .14). However, treatment with EBRT alone or EBRT with BT was consistently associated with lower rates of distant metastasis compared with treatment with RP (eg, EBRT vs RP: sHR, 0.50 [95% CI, 0.44-0.58]; P < .001).

Conclusions And Relevance: These findings suggest that among patients with high-risk prostate cancer and additional unfavorable clinicopathologic features receiving guideline-concordant multimodal therapy, prostate cancer-specific mortality outcomes were equivalent among those treated with RP, EBRT, and EBRT with BT, although distant metastasis outcomes were more favorable among patients treated with EBRT and EBRT with BT. Optimal multimodality treatment is critical for improving outcomes in patients with high-risk prostate cancer.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.15312DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251338PMC
July 2021

The Impact of Body Mass Index on Freedom From Therapeutic Intervention and Quality of Life in Active Surveillance Prostate Cancer Patients.

Am J Clin Oncol 2021 Jun 7. Epub 2021 Jun 7.

Schiffler Cancer Center, Urologic Research Institute Departments of Urology Pathology, Wheeling Hospital, Wheeling, WV.

Objective: The objective of this study was to evaluate the impact of body mass index (BMI) on overall survival, freedom from distant metastases, rates of therapeutic intervention (TI), and quality of life (QOL) in active surveillance (AS) prostate cancer patients.

Materials And Methods: Three hundred forty consecutive, prospectively evaluated AS patients underwent a staging transperineal template-guided mapping biopsy before AS enrollment and were stratified by BMI (<25, 25 to 29.9, 30 to 34.9, and >35 kg/m2). Evaluated outcomes included overall survival, freedom from distant metastases, TI, QOL to include urinary, bowel, sexual function and depression and serial postvoid residual urine measurements. The relationship between BMI and anterior prostate cancer distribution was evaluated. Repeat biopsy was based on prostate specific antigen kinetics, abnormal digital rectal examination and patient preference.

Results: Of the 340 patients, 323 (95%) were Gleason 3+3 and 17 patients (5.0%) were Gleason 3+4. The median follow-up was 5.2 years (range: 1 to 14 y). At 10 years, TI was instituted in 4.7%, 2.2%, 9.5%, and 25.0% of patients in BMI cohorts <25, 25 to 29.9, 30 to 34.9, and ≥35 (P=0.075). No patient has developed distant metastases. The median time to TI was 4.86 years. In multivariate analysis, TI was most closely predicted by prostate specific antigen density (P=0.071). At 8 years, no statistical differences in urinary function, bowel function, depression or postvoid residual were noted. However, a trend for erectile dysfunction was identified (P=0.106).

Conclusion: At 10 years, BMI did not statistically predict for TI, geographic distribution of prostate cancer or QOL parameters.
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http://dx.doi.org/10.1097/COC.0000000000000839DOI Listing
June 2021

Patterns of Clinical Progression in Radiorecurrent High-risk Prostate Cancer.

Eur Urol 2021 Aug 10;80(2):142-146. Epub 2021 May 10.

Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

The natural history of radiorecurrent high-risk prostate cancer (HRPCa) is not well-described. To better understand its clinical course, we evaluated rates of distant metastases (DM) and prostate cancer-specific mortality (PCSM) in a cohort of 978 men with radiorecurrent HRPCa who previously received either external beam radiation therapy (EBRT, n = 654, 67%) or EBRT + brachytherapy (EBRT + BT, n = 324, 33%) across 15 institutions from 1997 to 2015. In men who did not die, median follow-up after treatment was 8.9 yr and median follow-up after biochemical recurrence (BCR) was 3.7 yr. Local and systemic therapy salvage, respectively, were delivered to 21 and 390 men after EBRT, and eight and 103 men after EBRT + BT. Overall, 435 men developed DM, and 248 were detected within 1 yr of BCR. Measured from time of recurrence, 5-yr DM rates were 50% and 34% after EBRT and EBRT + BT, respectively. Measured from BCR, 5-yr PCSM rates were 27% and 29%, respectively. Interval to BCR was independently associated with DM (p < 0.001) and PCSM (p < 0.001). These data suggest that radiorecurrent HRPCa has an aggressive natural history and that DM is clinically evident early after BCR. These findings underscore the importance of further investigations into upfront risk assessment and prompt systemic evaluation upon recurrence in HRPCa. PATIENT SUMMARY: High-risk prostate cancer that recurs after radiation therapy is an aggressive disease entity and spreads to other parts of the body (metastases). Some 60% of metastases occur within 1 yr. Approximately 30% of these patients die from their prostate cancer.
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http://dx.doi.org/10.1016/j.eururo.2021.04.035DOI Listing
August 2021

Effect of the timing of hydrogel spacer placement on prostate and rectal dosimetry of low-dose-rate brachytherapy implants.

J Contemp Brachytherapy 2021 Apr 14;13(2):145-151. Epub 2021 Apr 14.

Schiffler Cancer Center, Wheeling Hospital, Wheeling, WV, USA.

Purpose: To verify the dose sparing effect of hydrogel spacer (SpaceOAR™) on rectal dosimetry for prostate brachytherapy, and to determine whether prostate and rectal dosimetry was affected by the time gap between hydrogel spacer injection and brachytherapy dosimetry.

Material And Methods: The Pd brachytherapy dosimetry of 174 consecutive intermediate- and high-risk patients injected with hydrogel was compared with a dosimetry of 174 contemporaneous patients without hydrogel injections. Of the SpaceOAR™ patients, 91 had hydrogel injected upon completion of brachytherapy implant, while the remaining 83 patients had hydrogel placed prior to external beam radiation therapy (EBRT), followed 2-10 weeks later by brachytherapy. Brachytherapy implants were either planned with the prostate undistorted by any hydrogel or planned with hydrogel in place. Dosimetry of the prostate and tissues at risk was determined from CT imaging on the day of brachytherapy implant.

Results: SpaceOAR™ significantly reduced mean and maximum rectal doses as well as rectal wall V, but there was a statistically significant reduction of planning target volume (PTV) D to 121.1% of the prescribed dose in hydrogel patients compared to 123.3% in the non-hydrogel patients. Rectal dosimetry was similar between patients injected with hydrogel after brachytherapy and those with spacer injected prior to EBRT. However, patients who had hydrogel placed prior to EBRT had statistically significantly higher dosimetry indices of PTV and urethra relative to those with spacer placed at the completion of brachytherapy.

Conclusions: There was a significant rectal dose sparing in the cohort with hydrogel spacer compared to a reference group without spacer injection. The rectal dose sparing effect was similar in the sub-group of patients injected with hydrogel prior to EBRT and the sub-group injected with hydrogel at the conclusion of brachytherapy.
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http://dx.doi.org/10.5114/jcb.2021.105281DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8060959PMC
April 2021

CT-PLANNED transperineal prostate BIOPSY IN patients without a rectum.

Urol Case Rep 2020 Nov 11;33:101409. Epub 2020 Sep 11.

Department of Pathology, Wheeling Hospital, 1 Medical Park, Wheeling, WV, 26003, USA.

A patient at risk of harboring prostate cancer with a history of ulcerative colitis surgically managed with total colectomy (including the distal rectum and anal canal) underwent CT-planned transperineal prostate biopsy with fluoroscopic guidance. We describe the planning and intraoperative technique to obtain prostate biopsy cores.
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http://dx.doi.org/10.1016/j.eucr.2020.101409DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7574335PMC
November 2020

Associations of multimorbidity and patient-reported experiences of care with conservative management among elderly patients with localized prostate cancer.

Cancer Med 2020 08 6;9(16):6051-6061. Epub 2020 Jul 6.

West Virginia University School of Pharmacy, Pharmaceutical Systems & Policy, Morgantown, WV, USA.

Background: Many elderly localized prostate cancer patients could benefit from conservative management (CM). This retrospective cohort study examined the associations of patient-reported access to care and multimorbidity on CM use patterns among Medicare Fee-for-Service (FFS) beneficiaries with localized prostate cancer.

Methods: We used linked Surveillance, Epidemiology, and End Results cancer Registry, Medicare Claims, and the Medicare Consumer Assessment of Healthcare Providers and Systems (MCAHPS) survey files. We identified FFS Medicare Beneficiaries (age ≥ 66; continuous enrollment in Parts A & B) with incident localized prostate cancer from 2003 to 2013 and a completed MCAHPS survey measuring patient-reported experiences of care within 24 months after diagnosis (n = 496). We used multivariable models to examine MCAHPS measures (getting needed care, timeliness of care, and doctor communication) and multimorbidity on CM use.

Results: Localized prostate cancer patients with multimorbidity were less likely to use CM (adjusted odds ratio (AOR)=0.42 (0.27- 0.66), P < .001); those with higher scores on timeliness of care (AOR = 1.21 (1.09, 1.35), P < .001), higher education attainment (3.21 = AOR (1.50,6.89), P = .003), and impaired mental health status (4.32 = AOR (1.86, 10.1) P < .001) were more likely to use CM.

Conclusion(s): Patient-reported experience with timely care was significantly and positively associated with CM use. Multimorbidity was significantly and inversely associated with CM use. Addressing specific modifiable barriers to timely care along the cancer continuum for elderly localized prostate cancer patients with limited life expectancy could reduce the adverse effects of overtreatment on health outcomes and costs.
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http://dx.doi.org/10.1002/cam4.3274DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7433828PMC
August 2020

The narrow door of success.

Brachytherapy 2020 Jan - Feb;19(1):1-5. Epub 2019 Nov 15.

Urologic Research Institute, Wheeling, WV. Electronic address:

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http://dx.doi.org/10.1016/j.brachy.2019.09.003DOI Listing
November 2019

Active surveillance outcomes in prostate cancer patients: the use of transperineal template-guided mapping biopsy for patient selection.

World J Urol 2020 Feb 24;38(2):361-369. Epub 2019 Apr 24.

Department Of Pathology, Wheeling Hospital, Wheeling, WV, 26003, USA.

Purpose: To evaluate active surveillance (AS) outcomes including overall survival (OS), freedom from distant metastases (FDM), freedom from therapeutic intervention (FTI), and quality of life (QOL) outcomes in prostate cancer patients using transperineal template-guided mapping biopsy (TTMB) for patient selection.

Methods: From April 2005-January 2016, 226 consecutive, prospectively evaluated prostate cancer patients underwent TTMB for either low-grade prostate cancer or persistently elevated prostate-specific antigen (PSA) and/or the presence of ASAP. Evaluated outcomes included OS, FDM, FTI and QOL including urinary, bowel, sexual function and depression. Repeat biopsy was based on PSA kinetics and/or abnormal digital rectal examination.

Results: Of the 226 patients, 212 (93.8%) were Gleason 3 + 3 and 14 (6.2%) were Gleason 3 + 4. The median follow-up was 5.0 years (range 0.8-13.0 years). The mean prostate volume was 61.3 cm with a mean of 59.5 TTMB cores/patient. At the time of AS enrollment, an average of 72.9 cores (TRUS + TTMB) had been obtained for each patient. At 8 years, OS, FTI and FDM were 92.5, 96.8 and 100%. Two hundred and twenty-two patients (98.2%) had a PSA doubling time of more than 3 years. No statistical changes in urinary function, bowel function or depression were noted. At 8 years, 73% of the patients maintained erectile function.

Conclusion: Within the confines of the follow-up of this study, the use of TTMB for patient selection identifies a cohort of patients unlikely to develop biochemical or clinical progression and maintain a favorable quality of life.
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http://dx.doi.org/10.1007/s00345-019-02695-wDOI Listing
February 2020

Prostate-only Versus Whole-pelvis Radiation with or Without a Brachytherapy Boost for Gleason Grade Group 5 Prostate Cancer: A Retrospective Analysis.

Eur Urol 2020 01 13;77(1):3-10. Epub 2019 Apr 13.

Department of Radiation Oncology, Veteran Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, USA.

Background: The role of elective whole-pelvis radiotherapy (WPRT) remains controversial. Few studies have investigated it in Gleason grade group (GG) 5 prostate cancer (PCa), known to have a high risk of nodal metastases.

Objective: To assess the impact of WPRT on patients with GG 5 PCa treated with external-beam radiotherapy (EBRT) or EBRT with a brachytherapy boost (EBRT+BT).

Design, Setting, And Participants: We identified 1170 patients with biopsy-proven GG 5 PCa from 11 centers in the United States and one in Norway treated between 2000 and 2013 (734 with EBRT and 436 with EBRT+BT).

Outcome Measurements And Statistical Analysis: Biochemical recurrence-free survival (bRFS), distant metastasis-free survival (DMFS), and prostate cancer-specific survival (PCSS) were compared using Cox proportional hazards models with propensity score adjustment.

Results And Limitations: A total of 299 EBRT patients (41%) and 320 EBRT+BT patients (73%) received WPRT. The adjusted 5-yr bRFS rates with WPRT in the EBRT and EBRT+BT groups were 66% and 88%, respectively. Without WPRT, these rates for the EBRT and EBRT+BT groups were 58% and 78%, respectively. The median follow-up was 5.6yr. WPRT was associated with improved bRFS among patients treated with EBRT+BT (hazard ratio [HR] 0.5, 95% confidence interval [CI] 0.2-0.9, p=0.02), but no evidence for improvement was found in those treated with EBRT (HR 0.8, 95% CI 0.6-1.2, p=0.4). WPRT was not significantly associated with improved DMFS or PCSS in the EBRT group (HR 1.1, 95% CI 0.7-1.7, p=0.8 for DMFS and HR 0.7, 95% CI 0.4-1.1, p=0.1 for PCSS), or in the EBRT+BT group (HR 0.6, 95% CI 0.3-1.4, p=0.2 for DMFS and HR 0.5 95% CI 0.2-1.2, p=0.1 for PCSS).

Conclusions: WPRT was not associated with improved PCSS or DMFS in patients with GG 5 PCa who received either EBRT or EBRT+BT. However, WPRT was associated with a significant improvement in bRFS among patients receiving EBRT+BT. Strategies to optimize WPRT, potentially with the use of advanced imaging techniques to identify occult nodal disease, are warranted.

Patient Summary: When men with a high Gleason grade prostate cancer receive radiation with external radiation and brachytherapy, the addition of radiation to the pelvis results in a longer duration of prostate-specific antigen control. However, we did not find a difference in their survival from prostate cancer or in their survival without metastatic disease. We also did not find a benefit for radiation to the pelvis in men who received radiation without brachytherapy.
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http://dx.doi.org/10.1016/j.eururo.2019.03.022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7521828PMC
January 2020

Clinical Outcomes for Patients With Gleason Score 10 Prostate Adenocarcinoma: Results From a Multi-institutional Consortium Study.

Int J Radiat Oncol Biol Phys 2018 07 5;101(4):883-888. Epub 2018 Apr 5.

Department of Radiation Oncology, Veteran Affairs Greater Los Angeles Healthcare System, Los Angeles, California.

Purpose: Gleason score (GS) 10 disease is the most aggressive form of clinically localized prostate adenocarcinoma (PCa). The long-term clinical outcomes and overall prognosis of patients presenting with GS 10 PCa are largely unknown because of its rarity.

Methods And Materials: The study included 112 patients with biopsy-determined GS 10 PCa who received treatment with radical prostatectomy (RP, n = 26), external beam radiation therapy (EBRT, n = 48), or EBRT with a brachytherapy boost (EBRT-BT, n = 38) between 2000 and 2013. Propensity scores were included as covariates for comparative analysis. Overall survival, prostate cancer-specific survival, and distant metastasis-free survival (DMFS) were estimated by the Kaplan-Meier method with inverse probability of treatment weighting to control for confounding.

Results: The median follow-up period was 4.9 years overall (3.9 years for RP, 4.8 years for EBRT, and 5.7 years for EBRT-BT). Significantly more EBRT patients than EBRT-BT patients received upfront androgen deprivation therapy (98% vs 79%, P < .01 by χ test), though the durations were similar (median, 24 months vs 22.5 months). Of the RP patients, 34% received postoperative EBRT, and 35% received neoadjuvant systemic therapy. The propensity score-adjusted 5-year overall survival rate was 80% for the RP group, 73% for the EBRT group, and 83% for the EBRT-BT group. The corresponding adjusted 5-year prostate cancer-specific survival rates were 87%, 75%, and 94%, respectively. The EBRT-BT group trended toward superior DMFS when compared with the RP group (hazard ratio, 0.3; 95% confidence interval 0.1-1.06; P = .06) and had superior DMFS when compared with the EBRT group (hazard ratio, 0.4; 95% confidence interval 0.1-0.99; P = .048).

Conclusions: To our knowledge, this is the largest series ever reported on the clinical outcomes of patients with biopsy-determined GS 10 PCa. These data provide useful prognostic benchmark information for physicians and patients. Aggressive therapy with curative intent is warranted, as >50% of patients remain free of systemic disease 5 years after treatment.
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http://dx.doi.org/10.1016/j.ijrobp.2018.03.060DOI Listing
July 2018

Radical Prostatectomy, External Beam Radiotherapy, or External Beam Radiotherapy With Brachytherapy Boost and Disease Progression and Mortality in Patients With Gleason Score 9-10 Prostate Cancer.

JAMA 2018 03;319(9):896-905

Department of Urology, University of California, Los Angeles.

Importance: The optimal treatment for Gleason score 9-10 prostate cancer is unknown.

Objective: To compare clinical outcomes of patients with Gleason score 9-10 prostate cancer after definitive treatment.

Design, Setting, And Participants: Retrospective cohort study in 12 tertiary centers (11 in the United States, 1 in Norway), with 1809 patients treated between 2000 and 2013.

Exposures: Radical prostatectomy (RP), external beam radiotherapy (EBRT) with androgen deprivation therapy, or EBRT plus brachytherapy boost (EBRT+BT) with androgen deprivation therapy.

Main Outcomes And Measures: The primary outcome was prostate cancer-specific mortality; distant metastasis-free survival and overall survival were secondary outcomes.

Results: Of 1809 men, 639 underwent RP, 734 EBRT, and 436 EBRT+BT. Median ages were 61, 67.7, and 67.5 years; median follow-up was 4.2, 5.1, and 6.3 years, respectively. By 10 years, 91 RP, 186 EBRT, and 90 EBRT+BT patients had died. Adjusted 5-year prostate cancer-specific mortality rates were RP, 12% (95% CI, 8%-17%); EBRT, 13% (95% CI, 8%-19%); and EBRT+BT, 3% (95% CI, 1%-5%). EBRT+BT was associated with significantly lower prostate cancer-specific mortality than either RP or EBRT (cause-specific HRs of 0.38 [95% CI, 0.21-0.68] and 0.41 [95% CI, 0.24-0.71]). Adjusted 5-year incidence rates of distant metastasis were RP, 24% (95% CI, 19%-30%); EBRT, 24% (95% CI, 20%-28%); and EBRT+BT, 8% (95% CI, 5%-11%). EBRT+BT was associated with a significantly lower rate of distant metastasis (propensity-score-adjusted cause-specific HRs of 0.27 [95% CI, 0.17-0.43] for RP and 0.30 [95% CI, 0.19-0.47] for EBRT). Adjusted 7.5-year all-cause mortality rates were RP, 17% (95% CI, 11%-23%); EBRT, 18% (95% CI, 14%-24%); and EBRT+BT, 10% (95% CI, 7%-13%). Within the first 7.5 years of follow-up, EBRT+BT was associated with significantly lower all-cause mortality (cause-specific HRs of 0.66 [95% CI, 0.46-0.96] for RP and 0.61 [95% CI, 0.45-0.84] for EBRT). After the first 7.5 years, the corresponding HRs were 1.16 (95% CI, 0.70-1.92) and 0.87 (95% CI, 0.57-1.32). No significant differences in prostate cancer-specific mortality, distant metastasis, or all-cause mortality (≤7.5 and >7.5 years) were found between men treated with EBRT or RP (cause-specific HRs of 0.92 [95% CI, 0.67-1.26], 0.90 [95% CI, 0.70-1.14], 1.07 [95% CI, 0.80-1.44], and 1.34 [95% CI, 0.85-2.11]).

Conclusions And Relevance: Among patients with Gleason score 9-10 prostate cancer, treatment with EBRT+BT with androgen deprivation therapy was associated with significantly better prostate cancer-specific mortality and longer time to distant metastasis compared with EBRT with androgen deprivation therapy or with RP.
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http://dx.doi.org/10.1001/jama.2018.0587DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885899PMC
March 2018

Does supplemental external beam radiation therapy impact urinary, bowel, and erectile function following permanent prostate brachytherapy?: results of two prospective randomized trials.

J Contemp Brachytherapy 2017 Oct 19;9(5):403-409. Epub 2017 Oct 19.

Department of Pathology, Wheeling Hospital, Wheeling, WV, USA.

Purpose: To evaluate the impact of supplemental external beam radiation therapy (EBRT) prior to permanent prostate brachytherapy on long term urinary, bowel, and erectile function.

Material And Methods: Patient administered urinary, bowel, and erectile quality of life (QoL) instrument were obtained prior to treatment and following brachytherapy. The study population was comprised of the 457 patients who were alive as of June 2016, had been randomized to two markedly different supplemental EBRT dose regimens and a third arm without supplemental EBRT, and had completed the June 2016 QoL survey. The need for urinary or bowel surgical intervention was prospectively recorded during routine follow-up. Multiple parameters were evaluated for effect on outcomes.

Results: The urinary catheter was removed on day 0 in 92.1% of patients and 0.4% required a post-implant transurethral prostatic resection (TURP). On average, the International Prostate Symptom Score (IPSS) normalized at week 14. The 10-year rate of urethral strictures was 5.3%. No significant differences were discerned between baseline and post-implant rectal function assessment score (RFAS), and no patient developed a rectal ulcer or fistula. The 10-year potency preservation rate was 50.3%. Supplemental EBRT did not affect urinary, bowel, or erectile function. Urethral strictures were most closely related to bulbomembranous urethral brachytherapy doses, post-implant rectal function to pre-implant hemorroidal bleeding, and RFAS and erectile function to pre-brachytherapy international index of erectile function and age.

Conclusions: Supplemental EBRT did not significantly effect catheter dependency, IPSS resolution, urethral stricture rate, the need for post-implant TURP, bowel, or erectile function. Careful attention to brachytherapy dose distributions appears to be most important in minimizing post-brachytherapy morbidity.
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http://dx.doi.org/10.5114/jcb.2017.70763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5705829PMC
October 2017

Prostate cancer-specific death in brachytherapy treated high-risk patients stratified by pre-treatment PSA.

J Contemp Brachytherapy 2017 Aug 30;9(4):297-303. Epub 2017 Aug 30.

Wheeling Hospital, Department of Pathology, Wheeling, WV, USA.

Purpose: To evaluate prostate-cancer specific mortality (PCSM) in a cohort of high-risk patients treated with a permanent prostate brachytherapy approach, stratified by pre-treatment PSA.

Material And Methods: 448 high-risk patients (NCCN criteria) underwent permanent prostate brachytherapy. High risk patients were stratified by pre-treatment PSA (≤ 10.0, 10.1-20, and > 20 ng/ml). Biochemical failure (BF), prostate cancer-specific mortality (PCSM), distant failure (DM), and overall mortality (OM) were assessed as a function of prognostic group. Multiple clinical, treatment, and dosimetric parameters were evaluated for impact on outcome.

Results: The 10-year OM, BF, and PCSM for the entire cohort were 28.5%, 13.3%, and 4.9%, respectively. At 10 years, PCSM was 2.5%, 10.7%, and 4.5% in the PSA ≤ 10, 10.1-20, and > 20 ng/ml groups, respectively. No statistically significant differences in BF or overall survival (OS) were noted when stratified by pre-treatment PSA. DF was the most common in the 10.1-20 ng/ml cohort (8.6% at 10 years). In multivariate analysis, PCSM was most closely related to percent positive biopsies ( = 0.001) and tobacco ( = 0.042).

Conclusions: High-risk prostate cancer treated with permanent prostate brachytherapy and supplemental external beam radiotherapy resulted in excellent long-term biochemical control and PCSM. Overall, PCSM was low in all cohorts but highest in the intermediate PSA group (10.1-20 ng/ml).
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http://dx.doi.org/10.5114/jcb.2017.69588DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5611460PMC
August 2017

The American College of Radiology and the American Brachytherapy Society practice parameter for transperineal permanent brachytherapy of prostate cancer.

Brachytherapy 2017 Jan - Feb;16(1):59-67

Roseville Radiation Oncology, Sutter Radiation Oncology Center, Roseville, CA, USA.

Transperineal permanent brachytherapy is a safe and effective treatment option for patients with organ-confined prostate cancer. Careful adherence to established brachytherapy standards has been shown to improve the likelihood of procedural success and reduce the incidence of treatment-related morbidity. A collaborative effort of the American College of Radiology (ACR) and the American Brachytherapy Society (ABS) has produced practice parameters for LDR prostate brachytherapy. These practice parameters define the qualifications and responsibilities of all the involved personnel, including the radiation oncologist, physicist and dosimetrist. Factors with respect to patient selection and appropriate use of supplemental treatment modalities such as external beam radiation and androgen suppression therapy are discussed. Logistics with respect to the brachytherapy implant procedure, the importance of dosimetric guidelines, and attention to radiation safety procedures and documentation are presented. Adherence to these parameters can be part of ensuring quality and safety in a successful prostate brachytherapy program.
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http://dx.doi.org/10.1016/j.brachy.2016.06.003DOI Listing
August 2017

Incidence, grade and distribution of prostate cancer following transperineal template-guided mapping biopsy in patients with atypical small acinar proliferation.

World J Urol 2017 Jul 29;35(7):1009-1013. Epub 2016 Nov 29.

Department of Pathology, Wheeling Hospital, Wheeling, WV, USA.

Purpose: To evaluate the role of transperineal template-guided mapping biopsy (TTMB) in patients with atypical small acinar proliferation (ASAP) diagnosed via transrectal ultrasound-guided needle biopsy (TRUS).

Methods: In total, 132 consecutive patients with TRUS-diagnosed ASAP underwent TTMB by means of an anatomic-based technique with sampling of 24 biopsy regions. For each of the 24 regions, 1-3 biopsy cores were obtained (depending on prostate size). No patient underwent pre-biopsy MRI imaging. The Gleason score, location of each positive biopsy core, the number of biopsy cores and percent involvement of each core were recorded. Anterior versus posterior cancer distribution was determined for both low- and high-grade (Gleason score ≥7) cancer.

Results: The mean patient age was 63.8 years with a mean PSA of 6.8 ng/mL. Of the 132 patients, 86 (65.2%) were diagnosed with prostate cancer. Of the entire cohort, 47 patients (54.7% of cancer patients and 35.6% of the entire cohort) were diagnosed with Gleason score ≥7. For both low- and high-grade cancers, the anterior gland and especially the anterior apex were the most common cancer locations.

Conclusion: In patients with ASAP, TTMB diagnosed prostate cancer in 65.2% of patients and 35.6% of the entire cohort had high-grade prostate cancer. A predilection for anterior-based cancers, especially the anterior apex, was identified. Our study may serve as a baseline reference for MRI-guided biopsy regimens.
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http://dx.doi.org/10.1007/s00345-016-1976-2DOI Listing
July 2017

American Brachytherapy Society Task Group Report: Combination of brachytherapy and external beam radiation for high-risk prostate cancer.

Brachytherapy 2017 Jan - Feb;16(1):1-12. Epub 2016 Oct 19.

Department of Radiation Oncology, Memorial Sloan Kettering, New York, NY.

Purpose: To review outcomes for high-risk prostate cancer treated with combined modality radiation therapy (CMRT) utilizing external beam radiation therapy (EBRT) with a brachytherapy boost.

Methods And Materials: The available literature for high-risk prostate cancer treated with combined modality radiation therapy was reviewed and summarized.

Results: At this time, the literature suggests that the majority of high-risk cancers are curable with multimodal treatment. Several large retrospective studies and three prospective randomized trials comparing CMRT to dose-escalated EBRT have demonstrated superior biochemical control with CMRT. Longer followup of the randomized trials will be required to determine if this will translate to a benefit in metastasis-free survival, disease-specific survival, and overall survival. Although greater toxicity has been associated with CMRT compared to EBRT, recent studies suggest that technological advances that allow better definition and sparing of critical adjacent structures as well as increasing experience with brachytherapy have improved implant quality and the toxicity profile of brachytherapy. The role of androgen deprivation therapy is well established in the external beam literature for high-risk disease, but there is controversy regarding the applicability of these data in the setting of dose escalation. At this time, there is not sufficient evidence for the omission of androgen deprivation therapy with dose escalation in this population. Comparisons with surgery remain limited by differences in patient selection, but the evidence would suggest better disease control with CMRT compared to surgery alone.

Conclusions: Due to a series of technological advances, modern combination series have demonstrated unparalleled rates of disease control in the high-risk population. Given the evidence from recent randomized trials, combination therapy may become the standard of care for high-risk cancers.
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http://dx.doi.org/10.1016/j.brachy.2016.09.006DOI Listing
August 2017

Impact of Androgen Deprivation Therapy on Overall Mortality in Prostate Brachytherapy Patients With Low Pretreatment Testosterone Levels.

Am J Clin Oncol 2018 07;41(7):667-673

Pathology, Wheeling Hospital, Wheeling, WV.

Objectives: To evaluate whether the use of androgen deprivation therapy (ADT) in prostate brachytherapy patients impacts overall mortality (OM) in patients with lower pretreatment serum testosterone levels compared with those with normal or high baseline serum testosterone.

Materials And Methods: From October 2001 to May 2014, 1916 patients underwent brachytherapy and had a pretreatment serum testosterone. Baseline serum testosterone values were collected prospectively before initiation of therapy. Median follow-up was 7.2 years. In total, 26% of the patients received ADT, primarily men with higher risk disease. OM and prostate cancer-specific mortality were examined to determine whether men with lower baseline serum testosterone were at increased risk of mortality when ADT was used, compared with men with baseline normal or higher testosterone.

Results: Prostate cancer-specific mortality and OM at 10 years was 0.8% and 22.0%. Age, tobacco use, diabetes, cardiovascular disease, and percent positive biopsies were the strongest predictors of OM. ADT use by itself was not associated with an increased risk of OM on multivariate analysis (P=0.695). However, ADT use in men with lower baseline testosterone was associated with a significantly higher risk of OM (P<0.01). ADT use in men with normal or higher baseline testosterone was not associated with an increased OM risk (P=0.924).

Conclusions: Men with lower baseline testosterone may be at increased risk of premature death when ADT is utilized compared with men with baseline normal or higher testosterone. Further analysis of this potential risk factor is warranted to further identify subsets of men who may be at higher risk of long-term adverse sequelae from ADT.
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http://dx.doi.org/10.1097/COC.0000000000000340DOI Listing
July 2018

Pathology and Quality of Life Outcomes Following Office-based Transperineal Prostate Biopsy.

Urology 2016 Aug 26;94:24-8. Epub 2016 Apr 26.

Department of Pathology, Wheeling Hospital, Wheeling, WV.

Objective: To report the incidence of prostate cancer diagnosis and quality of life outcomes following transperineal prostate biopsy.

Methods: Forty-six consecutive patients underwent office-based transperineal prostate biopsy for an elevated prostate-specific antigen and a normal digital rectal examination without prior prostate biopsy. Prior to biopsy, a repeat prostate-specific antigen was obtained to ensure persistent elevation. Silodosin (8 mg daily) was initiated the day prior to biopsy and continued for 1 week. A total of 18-20 biopsy cores were obtained per patient. All patients responded to a visual analog scale ranging from 0 to 10 immediately following the completion of both the local anesthesia and the biopsy procedure. In addition, an International Prostate Symptom Score (IPSS), Rectal Function Assessment Score, International Index of Erectile Function, Center for Epidemiologic Studies Depression Scale, and postvoid residual were obtained at baseline and 30 days following biopsy, except IPSS which was also obtained at day 7.

Results: The mean patient age was 63.3 years with a mean prostate volume of 41.8 cm(3). The mean visual analog scale was 4.2 for the local anesthesia and 3.0 for the biopsy. Thirty-one patients (67.4%) were diagnosed with prostate cancer, with 18 having a Gleason score ≥ 7. Compared to baseline, no adverse changes in IPSS, Rectal Function Assessment Score, International Index of Erectile Function, Center for Epidemiologic Studies Depression Scale, or postvoid residual were detected at day 30. No patient required catheterization, developed sepsis, or required hospitalization.

Conclusion: Office-based transperineal prostate biopsy was well tolerated with reasonable treatment-related discomfort, a high rate of prostate cancer diagnosis, and the absence of significant morbidity including sepsis.
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http://dx.doi.org/10.1016/j.urology.2016.04.020DOI Listing
August 2016

Focal prostate brachytherapy with (103)Pd seeds.

Phys Med 2016 Mar 1;32(3):459-64. Epub 2016 Apr 1.

Schiffler Cancer Center and Wheeling Jesuit University, Wheeling, WV, United States.

Purpose: Examine modifications to seed placement and target margins necessary to accomplish focal brachytherapy with (103)Pd.

Methods: Our proposed focal brachytherapy program will be primarily favorable intermediate-risk patients with a unilateral index lesion confirmed by transperineal template-guided mapping biopsies (TTMB). The dimensions and location of the TTMB core with the index lesion were placed within the 3-D ultrasound planning volume. Implants were planned for the prostate and the focal targets with generous margins. Planning goals were to cover the target with the 125Gy prescription dose and keep D90 (minimum dose covering 90% of the target) between 125% and 150% of the prescription while minimizing urethral and rectal hot spots. Radiobiological parameters - biologically effective dose (BED) and tumor control probability - were integrated over fractional sub-volumes and focal plans compared to whole gland brachytherapy.

Results: A typical 30.1cm(3) prostate was expanded to create a 50.6cm(3) planning target volume (PTV) and needed 22 needles containing 86 (103)Pd seeds of strength 3.20U to deliver the prescribed dose. The hemi-prostate required 39 seeds in 12 needles, and the focal core expanded to a target volume of 11.6cm(3) required 29 seeds in 8 needles. All cancerous PTVs and sub volumes had a tumoricidal BED while organs at risk (OAR) met the dose constraints minimizing morbidity.

Conclusions: For this single case study, both hemi-prostate and focal brachytherapy using (103)Pd seeds met the same target dosimetric goals and OAR constraints as whole prostate plans but with the expected reduction in number of seeds and needles.
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http://dx.doi.org/10.1016/j.ejmp.2016.03.012DOI Listing
March 2016

Stratification of brachytherapy-treated intermediate-risk prostate cancer patients into favorable and unfavorable cohorts.

J Contemp Brachytherapy 2015 Dec 30;7(6):430-6. Epub 2015 Dec 30.

Department of Pathology, Wheeling Hospital, Wheeling, WV, USA.

Purpose: To evaluate biochemical failure (BF) and prostate cancer specific mortality (PCSM) in intermediate-risk (IR) brachytherapy patients stratified into favorable and unfavorable cohorts, and to compare those outcomes to patients with low (LR) and high-risk (HR) disease.

Material And Methods: From March 1995 till February 2012, 2,502 consecutive patients underwent permanent interstitial brachytherapy for clinically localized prostate cancer. Patients were stratified into risk groups as per the NCCN guidelines with further stratification of the intermediate risk cohort into unfavorable (primary Gleason pattern 4, ≥ 50% positive biopsies or ≥ 2 IR features) and favorable cohorts. Median follow-up was 8.5 years. The brachytherapy prescription dose was prescribed to the prostate gland with generous periprostatic margins. Biochemical failure was defined as a PSA > 0.40 ng/ml after nadir. Patients with metastatic prostate cancer or non-metastatic castrate resistant disease who died of any cause were classified as dead of prostate cancer. Multiple parameters were evaluated for effect on outcomes.

Results: Fifteen year BF for LR, favorable IR, unfavorable IR, and HR were 1.4%, 2.2%, 7.1%, and 11.1% (p < 0.001), respectively. At 15 years, PCSM for LR, favorable IR, unfavorable IR, and HR was 0.3%, 0.6%, 2.2% and 4.6% (p < 0.001), respectively. In multivariate analysis, BF was best predicted by risk group, pre-implant PSA, percent positive biopsies, prostate volume, and ADT duration, while PCSM was most closely related to risk group, percent positive biopsies and prostate volume.

Conclusions: Patients with favorable IR disease have biochemical and PCSM outcomes comparable to those of patients with LR disease. Although unfavorable IR has greater than a 3-fold increased risk of BF and PCSM when compared to favorable IR, the outcomes remain superior to those men with HR disease.
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http://dx.doi.org/10.5114/jcb.2015.56763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4716130PMC
December 2015

Is supplemental external beam radiation therapy essential to maximize brachytherapy outcomes in patients with unfavorable intermediate-risk disease?

Brachytherapy 2016 Jan-Feb;15(1):79-84. Epub 2015 Nov 14.

Department of Pathology, Wheeling Hospital, Wheeling, WV.

Purpose: To evaluate whether supplemental external beam radiotherapy (EBRT) is essential to maximize Pd-103 brachytherapy outcomes in patients with unfavorable intermediate-risk (IR) disease.

Methods And Materials: A total of 630 patients were assessed from two prospective randomized brachytherapy trials evaluating the role of supplemental EBRT in patients with higher risk features. Patients were stratified into unfavorable IR (primary Gleason pattern 4, ≥50% positive biopsies, or ≥2 IR features), favorable IR, and high-risk (HR) cohorts. Median follow-up was 7.5 years. The brachytherapy prescription dose was prescribed to the prostate gland with generous periprostatic margins. Biochemical failure (BF) was defined as a prostate-specific antigen >0.40 ng/mL after nadir. Patients with metastatic prostate cancer or nonmetastatic castrate-resistant disease who died of any cause were classified as dead of prostate cancer. Multiple parameters were evaluated for effect on outcomes.

Results: The 10-year BF for favorable IR, unfavorable IR, and HR was 1.7%, 6.6%, and 15.5% (p < 0.001). At 10 years, prostate cancer-specific mortality (PCSM) and overall mortality (OM) were 0% and 20.4%, 2.1% and 23.2%, and 4.3% and 42.4% for favorable IR, unfavorable IR, and HR. Although unfavorable IR patients had a greater incidence of BF, PCSM, and OM when compared with favorable IR, neither the addition nor dose of supplemental EBRT influenced outcome.

Conclusions: Outcomes for favorable IR were superior to those with unfavorable IR. Within the confines of this study, neither the addition nor dose of supplemental EBRT influenced BF, PCSM, or OM in patients with IR disease.
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http://dx.doi.org/10.1016/j.brachy.2015.09.011DOI Listing
September 2016

Is supplemental external beam radiation therapy necessary for patients with higher risk prostate cancer treated with 103Pd? Results of two prospective randomized trials.

Brachytherapy 2015 Sep-Oct;14(5):677-85. Epub 2015 Jun 6.

Department of Pathology, Wheeling Hospital, Wheeling, WV.

Purpose: To determine the necessity and/or dose of supplemental external beam radiotherapy (EBRT) in conjunction with palladium-103 ((103)Pd) brachytherapy for high-risk prostate cancer patients.

Methods And Materials: Trial 44/20 randomized patients to 44 Gy plus 90 Gy (103)Pd vs. 20 Gy with 115 Gy (103)Pd, and the subsequent trial randomized patients to the 20 Gy arm vs. 125 Gy (103)Pd without EBRT (20/0 trial). Eligibility criteria included clinically organ-confined disease with Gleason scores 7-9 and/or a pretreatment prostate-specific antigen (PSA) 10-20 ng/mL. The brachytherapy prescription dose was prescribed to the prostate gland with generous periprostatic margins. Biochemical failure (BF) was defined as a PSA >0.40 ng/mL after nadir. Median Day 0 minimum dose covering 90% of the prostate volume (D90) was >121.0% of the prescription dose. Multiple parameters were evaluated for effect on outcomes.

Results: In 44/20 trial, 13-year BF, prostate cancer-specific mortality (PCSM), and overall mortality (OM) were 8.2%, 4.0%, and 42.8% vs. 8.0%, 1.0%. and 40.3% for the 44 and 20 Gy arms. In 20/0 trial, 8-year BF, PCSM, and OM were 2.1%, 0%, and 14.4% vs. 3.6%, 0%, and 16.1% in the 20 vs. 0 Gy arms. When stratified by either pretreatment PSA or by Gleason score, supplemental EBRT dose did not impact BF, PCSM, or OM. In multivariate analysis, BF was most closely related to percent positive biopsies and prostate volume. In both trials, patients with biochemically controlled disease had a median PSA of <0.02 ng/mL.

Conclusions: With high-quality brachytherapy dose distributions, supplemental EBRT did not influence BF or PCSM for patients with intermediate-risk disease. The number of patients with Gleason score 8-9 was too small to determine the role of supplemental EBRT in that cohort.
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http://dx.doi.org/10.1016/j.brachy.2015.05.001DOI Listing
May 2016

Metformin Does Not Predict for Prostate Cancer Diagnosis, Grade, or Volume of Disease After Transperineal Template-guided Mapping Biopsy.

Am J Clin Oncol 2017 Aug;40(4):353-357

*Schiffler Cancer Center, Wheeling Jesuit University Departments of †Urology §Pathology, Wheeling Hospital, Wheeling, WV ‡Ohio University Eastern, St Clairsville, OH.

Objectives: Previous studies have evaluated whether metformin is associated with prostate cancer incidence and outcomes with conflicting conclusions. In this study, we evaluate the incidence of prostate cancer in diabetic patients treated with and without metformin compared with nondiabetic patients.

Materials And Methods: One thousand thirty-four patients underwent transperineal template-guided mapping biopsy secondary to either an elevated prostate-specific antigen (PSA) or a prior biopsy finding of atypical small acinar proliferation/prostatic intraepithelial neoplasia. The cohort included 881 nondiabetic men, 65 diabetic men treated with metformin, and 88 diabetic men not receiving metformin. In metformin-treated patients, the median duration of usage was 6.0 years. Differences in prostate cancer diagnosis, histologic grade, and tumor volume were compared across the 3 cohorts.

Results: There was no statistically significant differences discerned between the 3 cohorts in patient age, prebiopsy PSA, prostate volume, PSA density, PSA doubling time, PSA velocity, or the total number of prior transrectal ultrasound biopsy sessions. Five hundred eighty-four patients were diagnosed with prostate cancer. There was no difference in prostate cancer diagnosis (P=0.153), Gleason score (P=0.960), the number of positive biopsy cores (P=0.764), or risk group stratification (P=0.877) between the 3 cohorts. In multivariate analysis, only older age predicted for prostate cancer diagnosis. In terms of Gleason score ≥7, patient age, PSA velocity, and body mass index predicted for more aggressive histology. Neither diabetes, metformin use or duration was of statistical consequence.

Conclusion: Metformin did not impact incidence of prostate cancer diagnosis, Gleason score distribution, or volume of disease.
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http://dx.doi.org/10.1097/COC.0000000000000174DOI Listing
August 2017

Severe rectal complications after prostate brachytherapy.

Radiother Oncol 2015 Feb 6;114(2):272-5. Epub 2015 Jan 6.

Urologic Research Institute, Wheeling Jesuit University, United States.

Purpose: Some investigators have reported severe rectal complications after brachytherapy. Due to the low number of such events, their relationship to dosimetric parameters has not been well characterized.

Methods And Materials: A total of 3126 patients were treated with low dose rate brachytherapy from 1998 through 2010. 2464 had implant alone, and 313 had implant preceded by 44-46Gy supplemental external beam radiation (EBRT). Post-implant dosimetry was based on a CT scan obtained on the day of implant, generally within 30min of the procedure. Every patient's record was reviewed for occurrence of rectal complications.

Results: Eight of 2464 patients (0.32%) treated with brachytherapy alone developed a radiation-related rectal fistula. Average prostatic and rectal dose parameters were moderately higher for fistula patients than for patients without a severe rectal complication. For instance, the average R100 was 1.2±0.75cc for fistula patients, versus 0.37±0.88cc for non-fistula patients. However, the fistula patients' values were well within the range of values for patients without a rectal complication. Four patients had some attempt at repair or reconstruction, but long-term functional outcomes were not favorable.

Conclusions: Rectal fistulas are a very uncommon potential complication of prostate brachytherapy, which can occur even in the setting of acceptable day 0 rectal doses. Their occurrence is not easily explained by standard dosimetric or clinical factors.
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http://dx.doi.org/10.1016/j.radonc.2014.12.001DOI Listing
February 2015

ACR appropriateness Criteria® Postradical prostatectomy irradiation in prostate cancer.

Oncology (Williston Park) 2014 Dec;28(12):1125-30, 1132-6

The purpose of this article is to present an updated set of American College of Radiology consensus guidelines formed from an expert panel on the appropriate use of radiation therapy in postprostatectomy prostate cancer. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances where evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment. Recent and relevant literature reviewed by the panel led to establishment of criteria for appropriate use of radiation therapy in postprostatectomy prostate cancer. The discussion includes treatment technique, appropriate dose, field design, and the role of prostate-specific antigen (PSA). Ratings and commentary of the panel on multiple treatment parameters were used to reach consensus. Patients with high-risk pathologic features benefit from postprostatectomy radiation therapy.
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December 2014

Effect of metal hip prosthesis on the accuracy of electromagnetic localization tracking.

Pract Radiat Oncol 2015 Jan-Feb;5(1):43-8. Epub 2014 May 14.

Schiffler Cancer Center and Wheeling Jesuit University, Wheeling, West Virginia. Electronic address:

Purpose: To quantify the effect of metal hip prosthesis on the ability to track and localize electromagnetic transponders.

Methods And Materials: Three Calypso Beacon (Varian Medical Systems, Palo Alto, CA) transponders were implanted into 2 prostate phantoms. The geometric center of the transponders were identified on computed tomography and set as the isocenter. With the phantom stationary on the treatment table and the tracking array 14-cm above the isocenter, data were acquired by the Calypso system at 10 Hz to establish the uncertainty in measurements. Transponder positional data were acquired with unilateral hip prostheses of different metallic compositions and then with bilateral hips placed at variable separation from the phantom.

Results: Regardless of hip prosthesis composition, the average vector displacement in the presence of a unilateral prosthesis was <0.5 mm. The greatest contribution to overall vector displacement occurred in the lateral dimension. With bilateral hip prosthesis, the average vector displacement was 0.3 mm. The displacement in the lateral dimension was markedly reduced compared with a unilateral hip, suggesting that there was a countervailing effect with bilateral hip prosthesis. The greatest average vector displacement was 0.6 mm and occurred when bilateral hip prostheses were placed within 4 cm of the detector array.

Conclusions: Unilateral and bilateral hip prostheses did not have any meaningful effect on the ability to accurately track electromagnetic transponders implanted in a prostate phantom. At clinically realistic distances between the hip and detection array, the average tracking error is negligible.
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http://dx.doi.org/10.1016/j.prro.2014.03.010DOI Listing
October 2015

Metformin is not associated with improved biochemical free survival or cause-specific survival in men with prostate cancer treated with permanent interstitial brachytherapy.

J Contemp Brachytherapy 2014 Oct 6;6(3):254-61. Epub 2014 Oct 6.

Department of Pathology, Wheeling Hospital, Wheeling, WV, USA.

Purpose: Several recent studies have suggested improved clinical outcomes in diabetic men with prostate cancer who also use metformin. We explore whether metformin use is associated with improved outcomes specifically in men undergoing prostate brachytherapy.

Material And Methods: 2,298 consecutive patients underwent permanent interstitial brachytherapy by a single brachytherapist (GSM). The cohort included 2028 non-diabetic men, 144 men with diabetes who were not taking metformin, and 126 men with diabetes who were taking metformin. Median follow up was 8.3 years. Differences in biochemical free survival, cause specific survival, and overall survival between men taking metformin and those not taking metformin were compared using Kaplan-Meier curves and log rank tests.

Results: Fifteen year biochemical failure rate, cause specific mortality and overall mortality for non-diabetic men was 4.6%, 1.5%, 47.0%, respectively; for diabetic men taking metformin 4.8%, 2.0%, 37.2%; and for diabetic men not taking metformin was 2.8%, 0%, 72.7%, respectively. Metformin use was not predictive in multivariate analysis of biochemical failure or prostate cancer specific mortality. However, diabetic men not taking metformin had higher overall mortality than non-diabetic men.

Conclusions: Metformin use was not associated with improved biochemical survival or cancer specific survival in this cohort of men treated with prostate brachytherapy.
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http://dx.doi.org/10.5114/jcb.2014.45757DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4200187PMC
October 2014

Transperineal Template-guided Mapping Biopsy Identifies Pathologic Differences Between Very-Low-risk and Low-risk Prostate Cancer: Implications for Active Surveillance.

Am J Clin Oncol 2017 02;40(1):53-59

*Schiffler Cancer Center, Wheeling Hospital, Wheeling Jesuit University Departments of †Urology ‡Pathology, Wheeling Hospital, Wheeling, WV.

Objectives: Active surveillance (AS) is increasingly utilized for low-grade prostate cancer with the greatest risk being the possibility of missing a high-grade cancer. We evaluate the role of transperineal template-guided mapping biopsy (TTMB) to select patients for AS.

Methods: A total of 131 consecutive, prospectively evaluated men with transrectal ultrasound-guided needle biopsy (TRUS)-diagnosed very low risk (Gleason score ≤6, ≤2 positive biopsies, prostate-specific antigen [PSA] density <0.15, and ≤50% involvement on any core) and low risk (Gleason score ≤6, clinical stage T1c, and PSA ≤10 ng/mL) underwent TTMB as a staging procedure. Biopsies were obtained corresponding to 24 regional biopsy locations. For each patient, the location of each positive biopsy core, the number of positive cores, and the percentage involvement of each core were reported.

Results: After TTMB, TRUS-detected very-low-risk prostate cancer patients were less likely to be diagnosed with higher Gleason score, were less likely to have bilateral involvement, and had statistically fewer number of positive biopsy cores on TTMB. After TTMB, no cancer, very-low-risk, or low-risk prostate cancer was detected in 60 of 72 (83.3%) and 19 of 59 (32.2%) of patients with very low and low risk, respectively. In multivariate analysis, older age and low risk predicted for higher Gleason score at the time of TTMB.

Conclusions: Very-low-risk prostate cancer patients have a significantly lower incidence of Gleason score upgrading than those with low-risk disease. After TTMB, 83.3% of patients with very-low-risk and 32.2% of patients with low-risk disease appear to be outstanding candidates for AS.
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http://dx.doi.org/10.1097/COC.0000000000000105DOI Listing
February 2017

Treatment Outcomes in Very High-risk Prostate Cancer Treated by Dose-escalated and Combined-Modality Radiation Therapy.

Am J Clin Oncol 2016 Apr;39(2):181-8

*Department of Radiation Oncology, University of Michigan Health System, Ann Arbor, MI †Radiation Oncology, Rambam Health Care Campus, Haifa, Israel ‡Schiffler Cancer Center, Wheeling Jesuit University, Wheeling, WV.

Objectives: The aim of this study was to report treatment outcomes in patients with very high-risk prostate cancer (VHRPC) treated with dose-escalated radiotherapy.

Methods: We conducted a retrospective multi-institutional review on patients with VHRPC (those with at least 2 high-risk factors of prostate-specific antigen >20 ng/mL, Gleason score 8 to 10, or clinical T3 to T4 stage), treated with either dose-escalated external-beam radiotherapy (EBRT) or combined-modality radiotherapy (CMRT) consisting of pelvic irradiation and permanent interstitial brachytherapy.

Results: A total of 238 patients with VHRPC were identified. Of them, 69% of patients received EBRT and 31% received CMRT; 88% received androgen-deprivation therapy (ADT), 56% for ≥24 months (long-term ADT). The majority (69%) of patients were above 65 years old and were less likely to receive CMRT than younger patients (25% vs. 43%, P=0.006), although they did not differ from younger patients in tumor characteristics. Median follow-up was 61 months (interquartile range, 38 to 93 mo). Biochemical progression-free survival (BPFS), distant metastasis-free survival (DMFS), and cancer-specific survival (CSS) for all patients at 8 years were (±SE): 50.6%±4.7%, 68.5%±4.3%, 78.7%±3.8%, respectively, and were similar for patients 65 years and below versus above 65 years old (BPFS: HR=0.88, P=0.56; DMFS: HR=0.79, P=0.40; CSS HR=0.99, P=0.99). After adjustment for patient, tumor, and treatment-related covariates on multivariate analysis, CMRT was associated with improved BPFS (HR=0.44, P=0.012) with trends for DMFS (HR=0.52, P=0.10) and CSS (HR=0.55, P=0.21), whereas long-term ADT was independently associated with improved BPFS (HR=0.40, P=0.019), CSS (HR=0.20, P=0.002), and PCSM (HR=0.25, P=0.004).

Conclusions: Dose-escalated EBRT or CMRT with long-term ADT resulted in favorable clinical outcomes for patients with VHRPC.
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http://dx.doi.org/10.1097/COC.0000000000000043DOI Listing
April 2016

Time to failure after definitive therapy for prostate cancer: implications for importance of aggressive local treatment.

J Contemp Brachytherapy 2013 Dec 3;5(4):215-21. Epub 2013 Dec 3.

Department of Pathology, Wheeling Hospital, Wheeling, USA.

Purpose: To explore patterns of time to failure in men receiving high doses of permanent seed brachytherapy with or without external beam radiation therapy as a function of risk status.

Material And Methods: Two thousand two hundred and thirty four patients were treated with prostate brachytherapy with median follow up of 8.0 years. The population was 35% low risk, 49% intermediate risk, and 16% high risk (NCCN). Median day 0 implant D90 was 119% and V100 was 98%. Treatment failure was defined as PSA > 0.40 ng/mL after nadir. Rates of biochemical failure, distant metastases, and prostate cancer death were determined with non-prostate death as a competing risk.

Results: For all patients, the 10-year biochemical failure, distant metastases, and cause-specific mortality were 4.4%, 1.4%, and 1.3%, respectively. The biochemical failure rates were 1.3%, 4.8%, and 10.0% for men with low, intermediate, and high risk disease, respectively. Median time to failure was 2.8 years. In men who died from prostate cancer, the median time from treatment failure to death was 4.2 years. Overall, 83% of biochemical failures and 97% of metastases occurred within the first 4 years after treatment.

Conclusions: With the dose escalation achieved by high quality brachytherapy dosimetry, even high-risk prostate cancer patients have excellent long term biochemical outcomes. Treatment failures occur early, and one third become metastatic and progress rapidly to prostate cancer death. The low frequency and pattern of failures suggest the presence of micrometastatic disease prior to treatment is rare, even in high risk patients.
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http://dx.doi.org/10.5114/jcb.2013.39210DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3899637PMC
December 2013
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