PD17-09 PROSPECTIVE RANDOMIZED TRIAL OF PARTIAL GLAND ABLATION WITH VASCULAR-TARGETED PHOTOTHERAPY VERSUS ACTIVE SURVEILLANCE FOR LOW RISK PROSTATE CANCER: 5 YEAR RESULTS

Abstract

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy I (PD17)1 Apr 2020PD17-09 PROSPECTIVE RANDOMIZED TRIAL OF PARTIAL GLAND ABLATION WITH VASCULAR-TARGETED PHOTOTHERAPY VERSUS ACTIVE SURVEILLANCE FOR LOW RISK PROSTATE CANCER: 5 YEAR RESULTS Inderbir Gill*, Peter Scardino, Andre Luis Abreu, and Rahmene Azzouzi Inderbir Gill*Inderbir Gill* More articles by this author , Peter ScardinoPeter Scardino More articles by this author , Andre Luis AbreuAndre Luis Abreu More articles by this author , and Rahmene AzzouziRahmene Azzouzi More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000860.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: PCM301 randomized 413 men with low risk prostate cancer (PCa) with ≤3 positive cores, 3-5mm max cancer core length (CCL), to partial gland ablation (PGA) with vascular-targeted photodynamic therapy (VTP: n=207) or active surveillance (AS: n=206) and followed them for 2 years. We report 5 year rates of conversion to radical therapy (RT) in each arm and for those with histologic disease progression (DP) prior to RT from PCM301, an extension study. METHODS: PCM301 subjects who did not withdraw consent were eligible for PCM301 5FU, which followed men for an additional 5 years. DP was defined as any of the following: >3 cores positive; any Gleason Grade Group ≥ 2 cancer; any CCL >5 mm; PSA>10 ng/mL on 3 consecutive occasions; any cT3; metastasis; or PCa related death, whichever came first. The absolute risk reductions for VTP vs. AS were computed by Kaplan-Meier analysis and a Cox proportional hazards model with a two-sided, unstratified log-rank test, including treatment effect, was performed to give a hazard ratio (HR) for conversion to RT in the VTP vs AS arms. RESULTS: Data were available for 318 subjects at month (M) 36, 301 at M 48, and 270 at M 60; VTP: 141 (68%) and AS: 129 (62%). The figures show the intent to treat analysis of rates of conversion to RT for (A) all subjects and (B) only those with DP prior to RT. Overall, 142 patients converted to RT: VTP: 50 (24%), AS: 92 (44%). The median time to RT was not reached in either arm due to the high proportion of censored observations. The absolute risk reduction for conversion to RT for VTP vs. AS remained stable from M 24 (25%) through M 36 (27%), M 48 (25%), and M 60 (24%). The HR for RT after VTP vs AS was 0.41 (95% CI, 0.29-0.58; p<0.0001). RT following DP was reported in 105 subjects: VTP: 39 (19%), AS: 66 (32%). The median time to initiation of RT after DP was not reached. The absolute risk reduction remained stable: 19%, 20%, 20% and 19% at M 24, M 36, M 48 and M 60, respectively. The HR for RT following DP for VTP vs. AS was 0.44 (95% CI, 0.30-0.66; p<0.001). CONCLUSIONS: Avoiding RT with its attendant morbidity is the major clinical benefit of VTP PGA for men with low risk PCa. Compared to AS, VTP significantly and durably reduced RT conversion for all subjects and those with objective DP. Source of Funding: Steba Biotech © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e372-e373 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Inderbir Gill* More articles by this author Peter Scardino More articles by this author Andre Luis Abreu More articles by this author Rahmene Azzouzi More articles by this author Expand All Advertisement PDF downloadLoading ...