MP46-04 RESULTS OF THE PCM-204 PHASE 2B TRIAL OF PARTIAL-GLAND ABLATION FOR MEN WITH INTERMEDIATE-RISK PROSTATE CANCER WITH PADELIPORFIN (WST11 OR TOOKAD) VASCULAR-TARGETED PHOTODYNAMIC THERAPY

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy (MP46)1 Sep 2021MP46-04 RESULTS OF THE PCM-204 PHASE 2B TRIAL OF PARTIAL-GLAND ABLATION FOR MEN WITH INTERMEDIATE-RISK PROSTATE CANCER WITH PADELIPORFIN (WST11 OR TOOKAD) VASCULAR-TARGETED PHOTODYNAMIC THERAPY Jonathan Coleman, Daniel Sjoberg, Quinlan Demac, Catriona Odea, Marlena McGill, Andrew Tracey, Lucas Nogueira, Andrew Vickers, Connie Estes, Jamie Kawwas, Nicole Benfante, Susan Slovin, Samson Fine, Oguz Akin, John Mulhall, Jaspreet Sandhu, Alvin Goh, Timothy Donahue, Brett Carver, Vincent Laudone, Behfar Ehdaie, Kwanghee Kim, Avigdor Scherz, Peter Scardino, and James Eastham Jonathan ColemanJonathan Coleman More articles by this author , Daniel SjobergDaniel Sjoberg More articles by this author , Quinlan DemacQuinlan Demac More articles by this author , Catriona OdeaCatriona Odea More articles by this author , Marlena McGillMarlena McGill More articles by this author , Andrew TraceyAndrew Tracey More articles by this author , Lucas NogueiraLucas Nogueira More articles by this author , Andrew VickersAndrew Vickers More articles by this author , Connie EstesConnie Estes More articles by this author , Jamie KawwasJamie Kawwas More articles by this author , Nicole BenfanteNicole Benfante More articles by this author , Susan SlovinSusan Slovin More articles by this author , Samson FineSamson Fine More articles by this author , Oguz AkinOguz Akin More articles by this author , John MulhallJohn Mulhall More articles by this author , Jaspreet SandhuJaspreet Sandhu More articles by this author , Alvin GohAlvin Goh More articles by this author , Timothy DonahueTimothy Donahue More articles by this author , Brett CarverBrett Carver More articles by this author , Vincent LaudoneVincent Laudone More articles by this author , Behfar EhdaieBehfar Ehdaie More articles by this author , Kwanghee KimKwanghee Kim More articles by this author , Avigdor ScherzAvigdor Scherz More articles by this author , Peter ScardinoPeter Scardino More articles by this author , and James EasthamJames Eastham More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002067.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Padeliporfin (WST11) vascular-targeted photodynamic therapy (VTP) has shown significant clinical benefit as a localized partial gland ablation (PGA) therapy when compared to active surveillance for low-risk prostate cancer, by curbing progression and the need for radical treatment, leading to its regulatory approval in Europe. This Phase 2b trial prospectively investigated WST11-VTP for intermediate-risk cancers. METHODS: 50 men with unilateral Grade Group 2 (GG2) cancers (Gleason 3+4) evaluated with MRI and ultrasound-guided (TRUS) biopsy were treated with up to 2 sessions of unilateral PGA using padeliporfin VTP. Eligibility criteria included <cT2b, PSA <10, and fusion biopsy for PIRADS 3+ lesions on pretreatment MRI. Contralateral very low–risk disease was observed. MRI and systematic, 14-core TRUS biopsy (+/- fusion) were performed 3 and 12 months after treatment, evaluating for Gleason Grade 4 or 5 (≥GG2) cancer as the primary endpoint. Additional data included adverse events and patient-reported quality of life. The study was powered using β=0.2 to reject the null hypothesis (r≤70%), using a one-sided exact binomial test with 5% alpha risk. To be valid, 44 evaluable patients were required by the 12-month primary endpoint. Treatment safety and patient-reported quality of life for sexual and urinary function were assessed with validated questionnaires (IIEF-15 and IPSS, respectively). RESULTS: 46 men were evaluable for the 12-month primary endpoint. Before 12 months, 1 man proceeded to prostatectomy (treatment failure), 2 men refused 12-month biopsy, and 1 man died of COVID-19. 12/49 (24%) underwent per-protocol second hemi-ablation treatment for GG2 tumor at 3 months: 9 for residual cancer and 4 with newly identified contralateral GG2 tumors (1 bilateral). 45 of the 46 evaluable men underwent 12-month biopsy: 38 (83%) had no Gleason grade 4 or 5 cancer, including 11/12 (92%) patients receiving 2 treatments. By 3 months, median decline in IIEF-5 score from baseline was -1.0 (IQR -7,0). Median improvement in IPSS score was -1.0 (IQR -1,5), with pad-free continence observed in 100% of patients. Median change in IIEF score by 12-months was -1.0 (IQR -5,0). Grade 3 treatment-related adverse events occurred in 6 (12%) patients; all procedure-related prostate/pelvic pain resolved by 3 weeks. CONCLUSIONS: These positive trial results show that WST11-VTP is effective for PGA of intermediate-risk prostate cancer with minimal toxicity including impact on urinary and sexual function, consistent with the Phase 3 trial results in low-risk disease. Based on these data this therapy bears consideration for approval as a conservative therapeutic option for selected cases of intermediate risk disease. Source of Funding: Thompson Family Foundation, Steba Biotech © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e814-e815 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jonathan Coleman More articles by this author Daniel Sjoberg More articles by this author Quinlan Demac More articles by this author Catriona Odea More articles by this author Marlena McGill More articles by this author Andrew Tracey More articles by this author Lucas Nogueira More articles by this author Andrew Vickers More articles by this author Connie Estes More articles by this author Jamie Kawwas More articles by this author Nicole Benfante More articles by this author Susan Slovin More articles by this author Samson Fine More articles by this author Oguz Akin More articles by this author John Mulhall More articles by this author Jaspreet Sandhu More articles by this author Alvin Goh More articles by this author Timothy Donahue More articles by this author Brett Carver More articles by this author Vincent Laudone More articles by this author Behfar Ehdaie More articles by this author Kwanghee Kim More articles by this author Avigdor Scherz More articles by this author Peter Scardino More articles by this author James Eastham More articles by this author Expand All Advertisement Loading ...

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