Publications by authors named "Mack Roach"

234 Publications

Adding short-term androgen deprivation therapy to RT in men with localized prostate cancer: long-term update of the NRG/RTOG 9408 randomized clinical trial.

Int J Radiat Oncol Biol Phys 2021 Sep 1. Epub 2021 Sep 1.

Massachusetts General Hospital Cancer Center, 55 Fruit St, Boston, MA 02114.

Purpose: For men with localized prostate cancer, xxxx demonstrated that adding short-term Androgen deprivation therapy (ADT) to radiotherapy (RT) improved the primary endpoint of overall-survival (OS) and also improved disease-specific-mortality (DSM), biochemical-failure (BF), local-progression (LP) and freedom from distant-metastases (DM). This study was performed to determine whether the short-term ADT continued to improve OS, DSM, BF, and freedom from DM with longer follow-up.

Methods And Materials: From 1994-2001, xxxx randomized 2028 men from 212 North American institutions with T1b-T2b, N0 prostate adenocarcinoma and PSA≤20ng/mL to RT-alone or RT plus short-term ADT. Patients were stratified by PSA, tumor-grade, and surgical versus clinical nodal staging. ADT was flutamide with either goserelin or leuprolide for 4 months. Prostate RT (66.6 Gy) was started after two months. OS was calculated at the date of death from any cause or at last follow-up. Secondary endpoints were DSM, BF, LP and DM. Acute and late toxic effects were assessed using **** toxicity scales.

Results: Median follow-up in surviving patients was 14.8 years (0.16-21.98). 10-year and 18-year OS was 56% and 23% with RT-alone versus 63% and 23% with combined-therapy (HR 0.94, 95%CI: 0.85-1.05, p=0.94). The hazards were not proportional (p=0.003). Estimated restricted-mean-survival-time at 18 years was 11.8 years (95%CI: 11.4-12.1) with combined-therapy versus 11.3 years with RT-alone (95%CI: 10.9-11.6, p=0.05). 10-year and 18-year DSM was 7% and 14% with RT-alone versus 3% and 8% with combined-therapy (HR=0.56, 95%CI: 0.41-0.75, p<0.01). DM and BF favored combined-therapy at 18 years. Rates of late grade ≥3 hepatic, gastrointestinal and genitourinary toxicity were ≤1%, 3%, 8% with combined-therapy versus ≤1%, 2%, 5% with RT-alone.

Conclusions: Further follow-up demonstrates that OS converges at approximately 15 years, by which point the administration of 4 months of ADT had conferred an estimated additional 6 months of life.
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http://dx.doi.org/10.1016/j.ijrobp.2021.08.031DOI Listing
September 2021

Salvage High-Dose-Rate Brachytherapy for Recurrent Prostate Cancer After Definitive Radiation.

Pract Radiat Oncol 2021 May 30. Epub 2021 May 30.

Department of Radiation Oncology, University of California, San Francisco, California. Electronic address:

Purpose: Salvage high-dose-rate brachytherapy (sHDRBT) for locally recurrent prostate cancer after definitive radiation is associated with biochemical control in approximately half of patients at 3 to 5 years. Given potential toxicity, patient selection is critical. We present our institutional experience with sHDRBT and validate a recursive partitioning machines model for biochemical control.

Materials And Methods: We performed a retrospective analysis of 129 patients who underwent whole-gland sHDRBT between 1998 and 2016. We evaluated clinical factors associated with biochemical control as well as toxicity.

Results: At diagnosis the median prostate-specific antigen (PSA) was 7.77 ng/mL. A majority of patients had T1-2 (73%) and Gleason 6-7 (82%) disease; 71% received external beam radiation therapy (RT) alone, and 22% received permanent prostate implants. The median disease-free interval (DFI) was 56 months, and median presalvage PSA was 4.95 ng/mL. At sHDRBT, 46% had T3 disease and 51% had Gleason 8 to 10 disease. At a median of 68 months after sHDRBT, 3- and 5-year disease-free survival were 85% (95% CI, 79-91) and 71% (95% CI, 62-79), respectively. Median PSA nadir was 0.18 ng/mL, achieved a median of 10 months after sHDRBT. Patients with ≥35%+ cores and a DFI <4.1 years had worse biochemical control (19% vs 50%, P = .02). Local failure (with or without regional/distant failure) was seen in 11% of patients (14/129), and 14 patients (11%) developed acute urinary obstruction requiring Foley placement and 19 patients (15%) developed strictures requiring dilation.

Conclusions: sHDRBT is a reasonable option for patients with locally recurrent prostate cancer after definitive RT. Those with <35%+ cores or an initial DFI of ≥4.1 years may be more likely to achieve long-term disease control after sHDRBT.
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http://dx.doi.org/10.1016/j.prro.2021.04.007DOI Listing
May 2021

Radiotherapy of oligometastatic prostate cancer: a systematic review.

Radiat Oncol 2021 Mar 9;16(1):50. Epub 2021 Mar 9.

Department of Radiation Oncology, University Hospital, LMU Munich, Marchioninistr. 15, 81377, Munich, Germany.

Background: Due to improved imaging sensitivity, the term "oligometastatic" prostate cancer disease is diagnosed more often, leading to an increasing interest in metastasis-directed therapy (MDT). There are two types of radiation based MDT applied when treating oligometastatic disease: (1) stereotactic body radiation therapy (SBRT) generally used for bone metastases; or (2) SBRT for isolated nodal oligometastases combined with prophylactic elective nodal radiotherapy. This review aims to summarize current evidence data, which may shed light on the optimal management of this heterogeneous group of patients.

Methods: A systematic review of the Medline database through PubMed was performed according to PRISMA guidelines. All relevant studies published up to November 2020 were identified and screened. Fifty-six titles were included. Besides outcome parameters, different prognostic and predictive factors were assessed, including site of metastases, time between primary treatment and MDT, use of systemic therapies, hormone sensitivity, as well as pattern of recurrence.

Findings: Evidence consists largely of retrospective case series and no consistent precise definition of oligometastasis exists, however, most investigators seem to acknowledge the need to distinguish between patients presenting with what is frequently called "synchronous" versus "metachronous" oligometastatic disease. Available data on radiotherapy as MDT demonstrate high local control rates and a small but relevant proportion of patients without progressive disease after 2 years. This holds true for both hormone sensitive and castration resistant prostate cancer diseases. The use of Ga-PSMA PET/CT for staging increased dramatically. Radiation doses and field sizes varied considerably among the studies. The search for relevant prognostic and predictive factors is ongoing.

Conclusions: To our best knowledge this review on oligometastatic prostate cancer included the largest number of original articles. It demonstrates the therapeutic potential and challenges of MDT for oligometastatic prostate cancer. Prospective studies are under way and will provide further high-level evidence.
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http://dx.doi.org/10.1186/s13014-021-01776-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7941976PMC
March 2021

Radiation Delay Is Okay, but Where Is the Evidence?

JAMA Oncol 2021 Mar;7(3):463-464

Helen Diller Family Comprehensive Cancer Center, Department of Radiation Oncology, University of California, San Francisco.

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http://dx.doi.org/10.1001/jamaoncol.2020.7612DOI Listing
March 2021

Considering benefit and risk before routinely recommending SpaceOAR.

Lancet Oncol 2021 01;22(1):11-13

Department of Radiation Oncology, Medical College of Wisconsin, WI 53226, USA.

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http://dx.doi.org/10.1016/S1470-2045(20)30639-2DOI Listing
January 2021

Stereotactic Body Radiation Therapy and High-Dose-Rate Brachytherapy Boost in Combination With Intensity Modulated Radiation Therapy for Localized Prostate Cancer: A Single-Institution Propensity Score Matched Analysis.

Int J Radiat Oncol Biol Phys 2021 06 30;110(2):429-437. Epub 2020 Dec 30.

Department of Radiation Oncology, University of California San Francisco, San Francisco, California. Electronic address:

Purpose: To perform a propensity-score matched analysis comparing stereotactic body radiation therapy (SBRT) boost and high-dose-rate (HDR) boost for localized prostate cancer.

Methods And Materials: A single-institution retrospective chart review was conducted of men treated with pelvic external beam radiation therapy (EBRT) and SBRT boost (21 Gy and 19 Gy in 2 fractions) to the prostate for prostate cancer. A cohort treated at the same institution with HDR brachytherapy boost (19 Gy in 2 fractions) was compared. Propensity-score (PS) matching and multivariable Cox regression were used for analysis. Outcomes were biochemical recurrence freedom (BCRF) and metastasis freedom (MF).

Results: One hundred thirty-one men were treated with SBRT boost and 101 with HDR boost with median follow-up of 73.4 and 186.0 months, respectively. In addition, 68.8% of men had high-risk and 26.0% had unfavorable-intermediate disease, and 94.3% received androgen deprivation therapy. Five- and 10-year unadjusted BCRF was 88.8% and 85.3% for SBRT and 91.8% and 74.6% for HDR boost (log-rank P = .3), and 5- and 10-year unadjusted MF was 91.7% and 84.3% for SBRT and 95.8% and 82.0% for HDR (log-rank P = .8). After adjusting for covariates, there was no statistically significant difference in BCRF (hazard ratio [HR] 0.81; 95% confidence interval [CI], 0.37-1.79; P = .6) or MF (HR 1.07; 95% CI, 0.44-2.57; P = .9) between SBRT and HDR boost. Similarly, after PS matching, there was no statistically significant difference between SBRT and HDR (BCRF: HR 0.66, 0.27-1.62, P = .4; MF: HR 0.84, 0.31-2.26, P = .7). Grade 3+ genitourinary and gastrointestinal toxicity in the SBRT cohort were 4.6% and 1.5%, and 3.0% and 0.0% in the HDR cohorts (P = .4, Fisher exact test).

Conclusions: SBRT boost plus pelvic EBRT for prostate cancer resulted in similar BCRF and MF to HDR boost in this single institution, PS matched retrospective analysis. Toxicity was modest. Prospective evaluation of SBRT boost for the treatment of unfavorable-intermediate and high-risk prostate cancer is warranted.
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http://dx.doi.org/10.1016/j.ijrobp.2020.12.034DOI Listing
June 2021

Prostate Radiotherapy With Adjuvant Androgen Deprivation Therapy (ADT) Improves Metastasis-Free Survival Compared to Neoadjuvant ADT: An Individual Patient Meta-Analysis.

J Clin Oncol 2021 01 4;39(2):136-144. Epub 2020 Dec 4.

Medical College of Wisconsin, Milwaukee, WI.

Purpose: There remains a lack of clarity regarding the influence of sequencing of androgen deprivation therapy (ADT) and radiotherapy (RT) on outcomes in prostate cancer (PCa). Herein, we evaluate the optimal sequencing of ADT with prostate-directed RT in localized PCa.

Methods: MEDLINE (1966-2018), Embase (1982-2018), ClinicalTrials.gov, and conference proceedings (1990-2018) were searched to identify randomized trials evaluating the sequencing, but not duration, of ADT with RT. Two randomized phase III trials were identified, and individual patient data were obtained: Ottawa 0101 and NRG Oncology's Radiation Therapy Oncology Group 9413. Ottawa 0101 randomly assigned patients to neoadjuvant or concurrent versus concurrent or adjuvant short-term ADT. Radiation Therapy Oncology Group 9413, a 2 × 2 factorial trial, included a random assignment of neoadjuvant or concurrent versus adjuvant short-term ADT. The neoadjuvant or concurrent ADT arms of both trials were combined into the neoadjuvant group, and the arms receiving adjuvant ADT were combined into the adjuvant group. The primary end point of this meta-analysis was progression-free survival (PFS).

Results: The median follow-up was 14.9 years. Overall, 1,065 patients were included (531 neoadjuvant and 534 adjuvant). PFS was significantly improved in the adjuvant group (15-year PFS, 29% 36%, hazard ratio [HR], 1.25 [95% CI, 1.07 to 1.47], = .01). Biochemical failure (subdistribution HR [sHR], 1.37 [95% CI, 1.12 to 1.68], = .002), distant metastasis (sHR, 1.40 [95% CI, 1.00 to 1.95], = .04), and metastasis-free survival (HR, 1.17 [95% CI, 1.00 to 1.37], = .050) were all significantly improved in the adjuvant group. There were no differences in late grade ≥ 3 gastrointestinal (2% 3%, = .33) or genitourinary toxicity (5% 5%, = .76) between groups.

Conclusion: The sequencing of ADT with prostate-directed RT has significant association with long-term PFS and MFS in localized PCa. Our findings favor use of an adjuvant over a neoadjuvant approach, without any increase in long-term toxicity.
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http://dx.doi.org/10.1200/JCO.20.02438DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8189640PMC
January 2021

Long-Term Results of NRG Oncology/RTOG 0321: A Phase II Trial of Combined High Dose Rate Brachytherapy and External Beam Radiation Therapy for Adenocarcinoma of the Prostate.

Int J Radiat Oncol Biol Phys 2021 07 10;110(3):700-707. Epub 2020 Nov 10.

Cedars-Sinai Medical Center.

Purpose: To report the long-term outcome of patients with prostate cancer treated with external beam radiation therapy and high dose rate (HDR) brachytherapy from a prospective multi-institutional trial conducted by NRG Oncology/RTOG.

Methods And Materials: Patients with clinically localized (T1c-T3b) prostate cancer without prior history of transurethral resection of prostate or hip prosthesis were eligible for this study. All patients were treated with a combination of 45 Gy in 25 fractions from external beam radiation therapy and one HDR implant delivering 19 Gy in 2 fractions. Adverse events (AE) were collected using Common Toxicity Criteria for Adverse Events, version 3. Cumulative incidence was used to estimate time to severe late gastrointestinal (GI)/genitourinary (GU) toxicity, biochemical failure, disease-specific mortality, local failure, and distant failure. Overall survival was estimated using the Kaplan-Meier method.

Results: One hundred and twenty-nine patients were enrolled from July 2004 to May 2006. AE data was available for 115 patients. Patients were National Comprehensive Cancer Network (NCCN) intermediate to very high risk. The median age was 68, T1c-T2c 91%, T3a-T3b 9%, PSA ≤10 70%, PSA >10 to ≤20 30%, GS 6 10%, GS 7 72%, and GS 8 to 10 18%. Forty-three percent of patients received hormonal therapy. At a median follow-up time of 10 years, there were 6 (5%) patients with grade 3 GI and GU treatment-related AEs, and no late grade 4 to 5 GI and GU AEs. At 5 and 10 years, the rate of late grade 3 gastrointestinal and genitourinary AEs was 4% and 5%, respectively. Five- and 10-year overall survival rates were 95% and 76%. Biochemical failure rates per Phoenix definition at 5 and 10 years were 14% and 23%. The 10-year rate of disease-specific mortality was 6%. At 5 and 10 years, the rates of distant failure were 4% and 8%, respectively. The rates of local failure at 5 and 10 years were 2% at both time points.

Conclusions: Combined modality treatment using HDR prostate brachytherapy leads to excellent long-term clinical outcomes in this prospective multi-institutional trial.
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http://dx.doi.org/10.1016/j.ijrobp.2020.11.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8107184PMC
July 2021

Phase II trial of SM-88, a cancer metabolism based therapy, in non-metastatic biochemical recurrent prostate cancer.

Invest New Drugs 2021 Apr 13;39(2):499-508. Epub 2020 Sep 13.

Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Background Androgen deprivation therapy (ADT) is a standard treatment for high-risk biochemically-recurrent, non-metastatic prostate cancer (BRPC) but is not curative and associated with toxicity. Racemetyrosine (SM-88) is an amino-acid analogue used with methoxsalen, phenytoin, and sirolimus (MPS) to enhance SM-88 activity. Method A phase 1b/2, open-label trial in BRPC and rising PSA. Patients were given daily SM-88 (230 mg BID), methoxsalen (10 mg), phenytoin (50 mg), and sirolimus (0.5 mg)). Outcome measures included changes in PSA, circulating tumor cells (CTCs) and imaging. Results 34 subjects were screened, 23 treated and 21 remained on study for ≥12 weeks. The median PSA was 6.4 ng/ml (range 1.7-80.1); doubling-time 6.2 months (range 1.4-36.6) and baseline testosterone 319.1 ng/ml (range 2.5-913.7). Median duration of therapy was 6.5 months (2.6-14.0). CTCs (median 48.5 cells/4 ml (range 15-268) at baseline) decreased a median of 65.3% in 18 of 19 patients. For patients who achieved an absolute CTC nadir count of <10 cells/4 ml (n = 10), disease control was 100% i.e. no metastases or PSA progression, while on trial (p = 0.005). PSA fell by ≥50% in 4.3% (1 subject). No patients developed metastatic disease while on treatment (metastases free survival =100%). There were no treatment-related adverse events (AEs) and quality of life was unchanged from baseline on the EORTC QLQ-C30 and QLQ-PR25. Testosterone levels rose slightly on SM-88 and were unrelated to efficacy or toxicity. Conclusions Use of SM-88 was associated with disease control while maintaining QOL. SM-88 may delay the need for ADT and the associated hormonal side effects. Larger trials are planned.Trial registration number, date of registration - NCT02796898, June 13, 2016.
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http://dx.doi.org/10.1007/s10637-020-00993-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7960617PMC
April 2021

Dramatic response to combination pembrolizumab and radiation in metastatic castration resistant prostate cancer.

Ther Adv Med Oncol 2020 25;12:1758835920936084. Epub 2020 Aug 25.

Department of Medicine, Division of Hematology/Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, 550 16th Street, Box 3211, San Francisco, CA, 94158, USA.

Immune checkpoint inhibitors targeting PD-1 and PD-L1 have demonstrated anti-tumor activity in several advanced solid malignancies. In previously treated metastatic castration resistant prostate cancer (mCRPC), a small subset of patients have a therapeutic response to checkpoint inhibition. Those who do respond to anti-PD-1/PD-L1 therapy have a marked, durable response to treatment, suggesting some derive long-term benefit from immune checkpoint blockade. In other cancers, one strategy to increase the efficacy of immune checkpoint blockade is to combine it with a pro-immune stimulatory agent, such as radiation. Here we present a case of a patient with heavily treated mCRPC who had a significant tumor response to concurrent pembrolizumab and radiation therapy to the primary prostatic mass. We review the growing evidence supporting the use of this combination therapy in other cancers and its potential benefit and safety in mCRPC. Our report highlights a potential therapeutic approach that should be further investigated in previously treated mCRPC.
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http://dx.doi.org/10.1177/1758835920936084DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7450451PMC
August 2020

Editorial Comment.

Authors:
Mack Roach

J Urol 2020 11 10;204(5):954. Epub 2020 Sep 10.

Radiation Oncology and Urology, University of California, San Francisco, San Francisco, California.

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http://dx.doi.org/10.1097/JU.0000000000001201.01DOI Listing
November 2020

Delaying Dilemmas: Coronavirus Complications Impacting the Management of Prostate Cancer.

Int J Radiat Oncol Biol Phys 2020 10;108(2):337

Department of Radiation Oncology, University of California San Francisco, San Francisco, California. Electronic address:

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http://dx.doi.org/10.1016/j.ijrobp.2020.07.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462932PMC
October 2020

Assessment of Postprostatectomy Radiotherapy as Adjuvant or Salvage Therapy in Patients With Prostate Cancer: A Systematic Review.

JAMA Oncol 2020 Nov;6(11):1793-1800

Robert H. Lurie Comprehensive Cancer Center, Division of Hematology/Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

Importance: After radical prostatectomy, adverse pathologic features and postoperative prostate-specific antigen (PSA) levels can herald disease recurrence or progression. Postoperative radiotherapy (RT) remains beneficial in this setting.

Objective: To examine the evidence supporting the use of postoperative RT as well as recent advances that help determine timing, scope, and use in combination with androgen deprivation therapy (ADT) with or without lymphatic irradiation.

Evidence Review: A search was conducted of MEDLINE (Ovid), Embase (Elsevier), and the Cochrane Library (Wiley) databases, in addition to clinical trial registries. The reference list of included studies was reviewed for relevant articles. The search was limited to studies published between January 1, 2014, and December 31, 2019.

Findings: After 548 citations were screened, 27 articles were selected for inclusion. In addition to conventional imaging, positron-emission tomographic (PET)-based radiotracers can aid in disease localization. While PET imaging may influence management with RT, studies are underway examining this issue, and several limitations must be considered, such as limited detectability at lower PSA levels and regional sensitivity. Available genomic classifiers can risk stratify patients or assess potential added benefit of RT. Prospective validation is underway with cooperative group trials. Adjuvant RT, on the basis of adverse pathologic features (such as extraprostatic extension or positive margins) is beneficial in terms of disease control, but it is unclear whether this therapy translates into more meaningful clinical benefit (eg, improved overall survival and a reduction in metastasis), which has been demonstrated by only 1 older, prospective randomized study. Preliminary data suggest that for a relatively favorable-risk population (low Gleason score but with positive margins), PSA monitoring may be a reasonable alternative in some men. Use of androgen deprivation therapy and lymphatic irradiation should be considered in higher-risk cohorts (those with high PSA, high Gleason score, seminal vesicle invasion or node positivity) in conjunction with postoperative RT.

Conclusions And Relevance: The findings of this review suggest that postprostatectomy RT should be considered for men with prostate cancer in the setting of adverse pathologic features; in carefully selected patients with favorable characteristics, close PSA monitoring is an option. Androgen deprivation therapy and pelvic lymphatic irradiation should be considered for higher risk cohorts (eg, higher PSA values, higher Gleason score). PET imaging and molecular studies remain unproven as decision tools.
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http://dx.doi.org/10.1001/jamaoncol.2020.2832DOI Listing
November 2020

Clinical recommendations in the management of advanced prostate cancer: International Gastrointestinal, Liver and Uro-oncology (IGILUC 2019) experts.

World J Urol 2021 May 8;39(5):1421-1429. Epub 2020 Jul 8.

Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Purpose: Advancements in the diagnosis and treatment of prostate cancer (PC) have rapidly progressed through the past years. Various factors should be taken into account while treating individual patients to ensure optimal and careful decision making. The purpose of this consensus review is to summarize the current practice patterns when managing patients with advanced prostate cancer (APC) as there is still a lack of or very limited evidence on its clinical management in some areas.

Methods: Pre-defined questions were shared with experts prior to the consensus session that took place in Cairo, Egypt in April 2019 during the 8th International gastrointestinal, liver and uro-oncology conference (IGILUC). Voting was based mainly on the expert opinions of the panel after a thorough discussion and review of available evidence from guidelines or best evidence available concerning the topic at hand.

Results: A strong consensus or unanimity was reached on 47% of the proposed questions. Notably, the panelists reached consensus on several topics based on high-level expert opinion. These findings contribute in several ways to our understanding of the management of PC and provide a basis for future recommendations. There was also a lack of consensus on other several topics, which suggests the need for further supporting data addressing these knowledge gaps.

Conclusion: This review offers a thorough understanding of APC practice and offers insight on the various opinions shared amongst experts in the field that can serve as guidance regionally and deepens our understanding of disease management globally.
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http://dx.doi.org/10.1007/s00345-020-03328-3DOI Listing
May 2021

The Roach Equation: Value of Old Clinical Tools in the Era of New Molecular Imaging.

J Nucl Med 2020 09 22;61(9):1292-1293. Epub 2020 May 22.

Department of Radiation Oncology and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California

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http://dx.doi.org/10.2967/jnumed.120.246736DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456176PMC
September 2020

Addition of Androgen-Deprivation Therapy or Brachytherapy Boost to External Beam Radiotherapy for Localized Prostate Cancer: A Network Meta-Analysis of Randomized Trials.

J Clin Oncol 2020 09 12;38(26):3024-3031. Epub 2020 May 12.

Department of Radiation Oncology, University of Michigan, Ann Arbor, MI.

Purpose: In men with localized prostate cancer, the addition of androgen-deprivation therapy (ADT) or a brachytherapy boost (BT) to external beam radiotherapy (EBRT) have been shown to improve various oncologic end points. Practice patterns indicate that those who receive BT are significantly less likely to receive ADT, and thus we sought to perform a network meta-analysis to compare the predicted outcomes of a randomized trial of EBRT plus ADT versus EBRT plus BT.

Materials And Methods: A systematic review identified published randomized trials comparing EBRT with or without ADT, or EBRT (with or without ADT) with or without BT, that reported on overall survival (OS). Standard fixed-effects meta-analyses were performed for each comparison, and a meta-regression was conducted to adjust for use and duration of ADT. Network meta-analyses were performed to compare EBRT plus ADT versus EBRT plus BT. Bayesian analyses were also performed, and a rank was assigned to each treatment after Markov Chain Monte Carlo analyses to create a surface under the cumulative ranking curve.

Results: Six trials compared EBRT with or without ADT (n = 4,663), and 3 compared EBRT with or without BT (n = 718). The addition of ADT to EBRT improved OS (hazard ratio [HR], 0.71 [95% CI, 0.62 to 0.81]), whereas the addition of BT did not significantly improve OS (HR, 1.03 [95% CI, 0.78 to 1.36]). In a network meta-analysis, EBRT plus ADT had improved OS compared with EBRT plus BT (HR, 0.68 [95% CI, 0.52 to 0.89]). Bayesian modeling demonstrated an 88% probability that EBRT plus ADT resulted in superior OS compared with EBRT plus BT.

Conclusion: Our findings suggest that current practice patterns of omitting ADT with EBRT plus BT may result in inferior OS compared with EBRT plus ADT in men with intermediate- and high-risk prostate cancer. ADT for these men should remain a critical component of treatment regardless of radiotherapy delivery method until randomized evidence demonstrates otherwise.
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http://dx.doi.org/10.1200/JCO.19.03217DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8265327PMC
September 2020

Understanding High-Dose, Ultra-High Dose Rate, and Spatially Fractionated Radiation Therapy.

Int J Radiat Oncol Biol Phys 2020 07 13;107(4):766-778. Epub 2020 Apr 13.

Division of Cancer Treatment and Diagnosis, Rockville, Maryland.

The National Cancer Institute's Radiation Research Program, in collaboration with the Radiosurgery Society, hosted a workshop called Understanding High-Dose, Ultra-High Dose Rate and Spatially Fractionated Radiotherapy on August 20 and 21, 2018 to bring together experts in experimental and clinical experience in these and related fields. Critically, the overall aims were to understand the biological underpinning of these emerging techniques and the technical/physical parameters that must be further defined to drive clinical practice through innovative biologically based clinical trials.
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http://dx.doi.org/10.1016/j.ijrobp.2020.03.028DOI Listing
July 2020

Management of Patients with Advanced Prostate Cancer: Report of the Advanced Prostate Cancer Consensus Conference 2019.

Eur Urol 2020 04 27;77(4):508-547. Epub 2020 Jan 27.

Division of Medical Oncology, National Cancer Centre, Singapore.

Background: Innovations in treatments, imaging, and molecular characterisation in advanced prostate cancer have improved outcomes, but there are still many aspects of management that lack high-level evidence to inform clinical practice. The Advanced Prostate Cancer Consensus Conference (APCCC) 2019 addressed some of these topics to supplement guidelines that are based on level 1 evidence.

Objective: To present the results from the APCCC 2019.

Design, Setting, And Participants: Similar to prior conferences, experts identified 10 important areas of controversy regarding the management of advanced prostate cancer: locally advanced disease, biochemical recurrence after local therapy, treating the primary tumour in the metastatic setting, metastatic hormone-sensitive/naïve prostate cancer, nonmetastatic castration-resistant prostate cancer, metastatic castration-resistant prostate cancer, bone health and bone metastases, molecular characterisation of tissue and blood, inter- and intrapatient heterogeneity, and adverse effects of hormonal therapy and their management. A panel of 72 international prostate cancer experts developed the programme and the consensus questions.

Outcome Measurements And Statistical Analysis: The panel voted publicly but anonymously on 123 predefined questions, which were developed by both voting and nonvoting panel members prior to the conference following a modified Delphi process.

Results And Limitations: Panellists voted based on their opinions rather than a standard literature review or formal meta-analysis. The answer options for the consensus questions had varying degrees of support by the panel, as reflected in this article and the detailed voting results reported in the Supplementary material.

Conclusions: These voting results from a panel of prostate cancer experts can help clinicians and patients navigate controversial areas of advanced prostate management for which high-level evidence is sparse. However, diagnostic and treatment decisions should always be individualised based on patient-specific factors, such as disease extent and location, prior lines of therapy, comorbidities, and treatment preferences, together with current and emerging clinical evidence and logistic and economic constraints. Clinical trial enrolment for men with advanced prostate cancer should be strongly encouraged. Importantly, APCCC 2019 once again identified important questions that merit assessment in specifically designed trials.

Patient Summary: The Advanced Prostate Cancer Consensus Conference provides a forum to discuss and debate current diagnostic and treatment options for patients with advanced prostate cancer. The conference, which has been held three times since 2015, aims to share the knowledge of world experts in prostate cancer management with health care providers worldwide. At the end of the conference, an expert panel discusses and votes on predefined consensus questions that target the most clinically relevant areas of advanced prostate cancer treatment. The results of the voting provide a practical guide to help clinicians discuss therapeutic options with patients as part of shared and multidisciplinary decision making.
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http://dx.doi.org/10.1016/j.eururo.2020.01.012DOI Listing
April 2020

Re: Identifying the Optimal Candidate for Salvage Lymph Node Dissection for Nodal Recurrence of Prostate Cancer: Results from a Large, Multi-institutional Analysis.

Eur Urol 2020 04 12;77(4):558-559. Epub 2019 Dec 12.

Department of Radiation Oncology and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA. Electronic address:

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http://dx.doi.org/10.1016/j.eururo.2019.11.027DOI Listing
April 2020

The association between BMI and BSA-temozolomide-induced myelosuppression toxicities: a correlative analysis of NRG oncology RTOG 0525.

Neurooncol Pract 2019 Dec 6;6(6):473-478. Epub 2019 Apr 6.

Baptist Hospital of Miami, FL.

Background: Fearing increased myelotoxicity, many practitioners adjust the body surface area (BSA)-calculated doses in obese patients. Regarding temozolomide (TMZ), a prior study suggested men with a BSA >2 m may experience increased toxicity; however, surprisingly, the inverse observation was noted in women, ie, BSA <2 m was associated with higher toxicity. To further clarify this issue, data derived from a large clinical trial were analyzed.

Methods: The incidence of grade 3 and 4 myelotoxicity in a newly diagnosed glioblastoma phase 3 trial (RTOG 0525) was statistically correlated with BMI and separately with BSA. All patients received radiation and TMZ followed by adjuvant standard dose TMZ vs dose-dense TMZ; dosing regimen-associated myelotoxicity and BMI/BSA were analyzed separately. was defined as a BMI ≥30.

Results: There was no statistically significant correlation between gender and BSA and the occurrence of myotoxicities. For the standard arm, surprisingly the incidence of grade 3/4 myotoxicities in patients with a BMI <30 was significantly higher than in patients with a BMI ≥30 (12% vs 1%, odds ratio [OR] 12.5, < .001). There was no significant difference between obese and nonobese patients (BMI "cut-point" of 30) in the dose-dense arm (OR = 0.9, 95% confidence interval: 0.4-1.6). The grade hematological 3/4 toxicity rate was significantly higher in women vs men (14% vs 8%) = .009 in spite of the lack of association between gender and BSA or BMI.

Conclusion: TMZ dosing based on actual BSA is recommended with the caveat that woman are likely at higher toxicity risk.
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http://dx.doi.org/10.1093/nop/npz006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899045PMC
December 2019

Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop.

J Urol 2020 01 10;203(1):115-119. Epub 2019 Sep 10.

United States Food and Drug Administration, Silver Spring, Maryland.

Purpose: The following is a summary of discussion at a United States FDA (Food and Drug Administration) public workshop reviewing potential trial designs and end points to develop therapies to treat localized prostate cancer.

Materials And Methods: The workshop focused on the challenge that drug and device development to treat localized prostate cancer has been limited by the large trial sizes and lengthy timelines required to demonstrate an improvement in overall or metastasis-free survival and by the lack of agreed on alternative end points. Additionally, evolving treatment paradigms in the management of localized prostate cancer include the widespread use of active surveillance of patients with low and some intermediate risk prostate cancer, and the availability of advances in imaging and genomics.

Results: The workshop addressed issues related to trial design in this setting. Attendees discussed several potential novel end points such as a delay of morbidity due to radiation or prostatectomy and pathological end points such as Gleason Grade Group upgrade.

Conclusions: The workshop provided an open forum for multiple stakeholder engagement to advance the development of effective treatment options for men with localized prostate cancer.
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http://dx.doi.org/10.1097/JU.0000000000000532DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8274949PMC
January 2020

Genomic Risk Predicts Molecular Imaging-detected Metastatic Nodal Disease in Prostate Cancer.

Eur Urol Oncol 2019 11 15;2(6):685-690. Epub 2019 Jan 15.

Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA; Department of Urology, University of California San Francisco, San Francisco, CA, USA. Electronic address:

Background: The Decipher genomic classifier (GC) is increasingly being used to determine metastasis risk in men with localized prostate cancer (PCa). Whether GCs predict for the presence of occult metastatic disease at presentation or subsequent metastatic progression is unknown.

Objective: To determine if GC scores predict extraprostatic Ga prostate-specific membrane antigen (Ga-PSMA-11) positron emission tomography (PET) positivity at presentation.

Design, Setting, And Participants: Between December 2015 and September 2018, 91 PCa patients with both GC scores and pretreatment Ga-PSMA-11 PET scans were identified. Risk stratification was performed using the National Comprehensive Cancer Network (NCCN), Cancer of the Prostate Risk Assessment (CAPRA), and GC scores.

Outcome Measurements And Statistical Analysis: Logistic regression was used to identify factors correlated with PSMA-positive disease.

Results And Limitations: The NCCN criteria identified 23 (25.3%) and 68 patients (74.7%) as intermediate and high risk, while CAPRA scores revealed 28 (30.8%) and 63 (69.2%) as low/intermediate and high risk, respectively. By contrast, only 45 patients (49.4%) had high-risk GC scores. PSMA-avid pelvic nodal involvement was identified in 27 patients (29.7%). Higher GC score was significantly associated with pelvic nodal involvement (odds ratio [OR] 1.38 per 0.1 units; p=0.009) and any PSMA-avid nodal involvement (pelvic or distant; OR 1.40 per 0.1 units; p=0.007). However, higher GC score was not significantly associated with PSMA-avid osseous metastases (OR 1.11 per 0.1 units; p=0.50). Limitations include selection bias for patients able to receive both tests and the sample size.

Conclusions: Each 0.1-unit increase in GC score was associated with an approximate 40% increase in the odds of PSMA-avid lymph node involvement. These data suggest that patients with GC high risk might benefit from more nodal imaging and treatment intensification, potentially via pelvic nodal dissection, pelvic nodal irradiation, and/or the addition of chemohormonal agents.

Patient Summary: Patients with higher genomic classifier scores were found to have more metastatic lymph node involvement on prostate-specific membrane antigen imaging.
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http://dx.doi.org/10.1016/j.euo.2018.11.002DOI Listing
November 2019

A Systematic Review of the Role of Definitive Local Treatment in Patients with Clinically Lymph Node-positive Prostate Cancer.

Eur Urol Oncol 2019 05 23;2(3):294-301. Epub 2019 Mar 23.

Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Department of Urology, Indiana University School of Medicine, Indianapolis, IN, USA.

Context: There is uncertainty regarding the oncologic effectiveness and the survival advantage of local treatment (LT) in men with clinically lymph node-positive (cN+) prostate cancer (PCa).

Objective: To systematically review the current literature comparing oncologic outcomes associated with the use of any form of LT for PCa patients with cN+ disease.

Evidence Acquisition: A computerized bibliographic search of the Medline, Embase, and Cochrane databases was performed for all studies reporting comparative oncologic outcomes of LT±androgen deprivation therapy (ADT) versus ADT alone. LT included both radical prostatectomy (RP) and radiotherapy (RT). Using the methodology recommended by the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, we identified five nonrandomized comparative retrospective studies published between 1999 and 2018, which were eligible for inclusion in this systematic review. A narrative review and risk-of-bias assessment were performed to determine the impact of LT on recurrence-free survival, cancer-specific survival (CSS), and overall survival (OS).

Evidence Synthesis: Four studies compared the use of RT±ADT versus ADT alone, whereas one study compared any form of LT±ADT versus ADT alone. Different statistical strategies were used in the included studies to account for baseline measured and unmeasured confounders. Overall, the use of RT and, generally speaking, any form of LT was associated with an OS as well as a CSS benefit over ADT alone, without any clear superiority shown either by RP±ADT or by RT±ADT.

Conclusions: Our systematic review suggests an advantage in terms of both OS and CSS for men with cN+ PCa receiving LT. However, these results should be interpreted with caution due to the low level of evidence of available reports.

Patient Summary: We reviewed the studies that assessed the role of local treatment in men with prostate cancer and with clinical evidence of lymph node involvement at diagnosis. We found that local treatment was constantly associated with recurrence-free, cancer-specific, and overall survival benefits throughout the included studies.
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http://dx.doi.org/10.1016/j.euo.2019.02.001DOI Listing
May 2019

Association of Black Race With Prostate Cancer-Specific and Other-Cause Mortality.

JAMA Oncol 2019 07;5(7):975-983

Department of Radiation Oncology, University of Michigan, Ann Arbor.

Importance: Black men are more likely to die of prostate cancer than white men. In men with similar stages of disease, the contribution of biological vs nonbiological differences to this observed disparity is unclear.

Objective: To quantify the association of black race with long-term survival outcomes after controlling for known prognostic variables and access to care among men with prostate cancer.

Design, Setting, And Participants: This multiple-cohort study included updated individual patient-level data of men with clinical T1-4N0-1M0 prostate cancer from the following 3 cohorts: Surveillance, Epidemiology, and End Results (SEER [n = 296 273]); 5 equal-access regional medical centers within the Veterans Affairs health system (VA [n = 3972]); and 4 pooled National Cancer Institute-sponsored Radiation Therapy Oncology Group phase 3 randomized clinical trials (RCTs [n = 5854]). Data were collected in the 3 cohorts from January 1, 1992, through December 31, 2013, and analyzed from April 27, 2017, through April 13, 2019.

Exposures: In the VA and RCT cohorts, all patients received surgery and radiotherapy, respectively, with curative intent. In SEER, radical treatment, hormone therapy, or conservative management were received.

Main Outcomes And Measures: Prostate cancer-specific mortality (PCSM). Secondary measures included other-cause mortality (OCM). To adjust for demographic-, cancer-, and treatment-related baseline differences, inverse probability weighting (IPW) was performed.

Results: Among the 306 100 participants included in the analysis (mean [SD] age, 64.9 [8.9] years), black men constituted 52 840 patients (17.8%) in the SEER cohort, 1513 (38.1%) in the VA cohort, and 1129 (19.3%) in the RCT cohort. Black race was associated with an increased age-adjusted PCSM hazard (subdistribution hazard ratio [sHR], 1.30; 95% CI, 1.23-1.37; P < .001) within the SEER cohort. After IPW adjustment, black race was associated with a 0.5% (95% CI, 0.2%-0.9%) increase in PCSM at 10 years after diagnosis (sHR, 1.09; 95% CI, 1.04-1.15; P < .001), with no significant difference for high-risk men (sHR, 1.04; 95% CI, 0.97-1.12; P = .29). No significant differences in PCSM were found in the VA IPW cohort (sHR, 0.85; 95% CI, 0.56-1.30; P = .46), and black men had a significantly lower hazard in the RCT IPW cohort (sHR, 0.81; 95% CI, 0.66-0.99; P = .04). Black men had a significantly increased hazard of OCM in the SEER (sHR, 1.30; 95% CI, 1.27-1.34; P < .001) and RCT (sHR, 1.17; 95% CI, 1.06-1.29; P = .002) IPW cohorts.

Conclusions And Relevance: In this study, after adjustment for nonbiological differences, notably access to care and standardized treatment, black race did not appear to be associated with inferior stage-for-stage PCSM. A large disparity remained in OCM for black men with nonmetastatic prostate cancer.
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http://dx.doi.org/10.1001/jamaoncol.2019.0826DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6547116PMC
July 2019

Optimizing Imperfect Patient Management Recommendations Post-prostatectomy.

Eur Urol Oncol 2018 05 15;1(1):19-20. Epub 2018 May 15.

Department of Preventive and Restorative Dental Sciences, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA; Department of Epidemiology and Biostatistics, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.

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http://dx.doi.org/10.1016/j.euo.2018.03.014DOI Listing
May 2018

Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology.

J Natl Compr Canc Netw 2019 05;17(5):479-505

Stanford Cancer Institute.

The NCCN Guidelines for Prostate Cancer include recommendations regarding diagnosis, risk stratification and workup, treatment options for localized disease, and management of recurrent and advanced disease for clinicians who treat patients with prostate cancer. The portions of the guidelines included herein focus on the roles of germline and somatic genetic testing, risk stratification with nomograms and tumor multigene molecular testing, androgen deprivation therapy, secondary hormonal therapy, chemotherapy, and immunotherapy in patients with prostate cancer.
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http://dx.doi.org/10.6004/jnccn.2019.0023DOI Listing
May 2019

Stampede to Cure.

Authors:
Yun R Li Mack Roach

Int J Radiat Oncol Biol Phys 2019 06;104(2):264

Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California; Department of Radiation Oncology, University of California San Francisco, San Francisco, California.

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http://dx.doi.org/10.1016/j.ijrobp.2018.09.046DOI Listing
June 2019

Prostate-Specific Antigen After Neoadjuvant Androgen Suppression in Prostate Cancer Patients Receiving Short-Term Androgen Suppression and External Beam Radiation Therapy: Pooled Analysis of Four NRG Oncology Radiation Therapy Oncology Group Randomized Clinical Trials.

Int J Radiat Oncol Biol Phys 2019 08 6;104(5):1057-1065. Epub 2019 Apr 6.

Cedars-Sinai Medical Center, Los Angeles, California.

Purpose: To validate whether prostate-specific antigen (PSA) level after neoadjuvant androgen suppression (neoAS) is associated with long-term outcome after neoAS and external beam radiation therapy (RT) with concurrent short-term androgen suppression (AS) in patients with prostate cancer.

Methods And Materials: This study included 2404 patients. The patients were treated with neoAS before RT and concurrent AS (without post-RT AS) and were pooled from NRG Oncology/RTOG trials 9202, 9408, 9413, and 9910. Multivariable models were used to test associations between the prespecified dichotomized post-neoAS, pre-RT PSA level (≤0.1 vs >0.1 ng/mL) groupings, and clinical outcomes.

Results: The median follow-up for surviving patients was 9.4 years. The median post-neoAS, pre-RT PSA level was 0.3 ng/mL, with 32% of patients having levels ≤0.1 ng/mL. Race, Gleason score, tumor stage, node stage, pretreatment PSA level, and duration of neoAS were associated with the groups of patients with PSA levels ≤0.1 and >0.1 ng/mL. In univariate analyses, post-neoAS, pre-RT PSA level >0.1 ng/mL was associated with increased risks of biochemical failure (hazard ratio [HR], 2.04; P < .0001); local failure (HR, 2.51; P < .0001); distant metastases (HR, 1.73; P = .0006); cause-specific mortality (HR, 2.36; P < .0001); and all-cause mortality (HR, 1.24; P = .005). In multivariable models that also included baseline and treatment variables, post-neoAS, pre-RT PSA level >0.1 ng/mL was independently associated with increased risk of biochemical failure (HR, 2.00; P < .0001); local failure (HR, 2.33; P < .0001); and cause-specific mortality (HR, 1.75; P = .03).

Conclusions: Patients with a PSA level >0.1 ng/mL after neoAS and before the start of RT had less favorable clinical outcomes than patients whose PSA level was ≤0.1 ng/mL. The role of post-neoAS, pre-RT PSA level relative to PSA levels obtained along the continuum of medical care is not presently defined but could be tested in future clinical trials.
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http://dx.doi.org/10.1016/j.ijrobp.2019.03.049DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6646073PMC
August 2019

Surgery Versus Radiation for High-risk Prostate Cancer: The Fight Continues. But Is It Time To Call a Draw and Reach Consensus?

Eur Urol 2019 04 11;75(4):556-557. Epub 2019 Jan 11.

Departments of Radiation Oncology & Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.

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http://dx.doi.org/10.1016/j.eururo.2018.12.032DOI Listing
April 2019

Impact of Staging Ga-PSMA-11 PET Scans on Radiation Treatment Plansin Patients With Prostate Cancer.

Urology 2019 03 21;125:154-162. Epub 2018 Dec 21.

University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; Department of Radiology and Biomedical Imaging, University of California, San Francisco, CA; Department of Radiology, San Francisco VA Medical Center, San Francisco, CA. Electronic address:

Objective: To evaluate the impact of staging Ga-PSMA-11 PET imaging on radiotherapy (RT) dose and volumes in patients with prostate cancer.

Methods: Forty-five patients (89% high or very high risk by NCCN criteria) who underwent Ga-PSMA-11 PET imaging prior to definitive treatment for prostate cancer between December 2015 and December 2016 were included. Locations of Ga-PSMA-11-avid lesions were compared to Radiation Therapy Oncology Group consensus pelvic nodal volumes (clinical target volume [CTV]); coverage of lesions outside the consensus CTV was considered a major change, while dose-escalation to lesions within the consensus CTV was considered a minor change.

Results: All patients had Ga-PSMA-11 PET uptake in the prostate. Twenty-five patients (56%) had N1/M1a disease on Ga-PSMA-11 PET scan, of whom 21 (47%) were previously N0. Six patients (13%) had bone metastases on Ga-PSMA-11 PET scan, of whom 4 had prior negative bone scans. Eight patients (18%) had lymph node metastases outside the consensus CTV. Twelve patients (27%) received a RT boost to nodes within the consensus CTV. Six patients (13%) had limited bone metastases treated with focal RT. Overall PSMA PET imaging resulted in major and/or minor changes to RT plans in 24 patients (53%).

Conclusion: Ga-PSMA-11 PET imaging resulted in RT changes in 53% of patients. Prospective investigation is needed to evaluate the clinical benefit of RT changes based on staging Ga-PSMA-11 PET imaging.
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http://dx.doi.org/10.1016/j.urology.2018.09.038DOI Listing
March 2019
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