Mp25-19 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 I (MP25)1 May 2024MP25-19 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 S. Fainberg, Behfar Ehdaie, Oguz Akin, Timothy Donahue, James Eastham, Connie Estes, Nicholas Fantanza, Samson Fine, Alvin Goh, Kwanghee Kim, Vincent Laudone, Nicole Liso, John P. Mulhall, Jamie Petrancosta, Jaspreet Sandhu, Peter Scardino, Avigdor Scherz, Susan Slovin, Andrew Vickers, and Jonathan Coleman Jonathan S. FainbergJonathan S. Fainberg , Behfar EhdaieBehfar Ehdaie , Oguz AkinOguz Akin , Timothy DonahueTimothy Donahue , James EasthamJames Eastham , Connie EstesConnie Estes , Nicholas FantanzaNicholas Fantanza , Samson FineSamson Fine , Alvin GohAlvin Goh , Kwanghee KimKwanghee Kim , Vincent LaudoneVincent Laudone , Nicole LisoNicole Liso , John P. MulhallJohn P. Mulhall , Jamie PetrancostaJamie Petrancosta , Jaspreet SandhuJaspreet Sandhu , Peter ScardinoPeter Scardino , Avigdor ScherzAvigdor Scherz , Susan SlovinSusan Slovin , Andrew VickersAndrew Vickers , and Jonathan ColemanJonathan Coleman View All Author Informationhttps://doi.org/10.1097/01.JU.0001008692.26556.39.19AboutPDF 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 (PC), by curbing disease progression and the need for definitive treatment. This Phase 2b trial investigated WST11-VTP for intermediate-risk PC and here we present 36 month follow up. METHODS: 50 men with unilateral Grade Group 2 (GG2) PC evaluated with MRI and ultrasound guided (TRUS) biopsy were treated with up to 2 sessions of unilateral VTP. Eligibility criteria included <cT2b, PSA<10, and fusion biopsy for PIRADS 3+ lesions on pretreatment MRI. Contralateral very low–risk disease (GG1) 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) PC as the primary endpoint. Additional biopsies were for-cause (clinical complete response or per standard of care for active surveillance candidates). Treatment safety and patient-reported quality of life for sexual and urinary function were assessed with validated questionnaires (IIEF-15 and IPSS). RESULTS: 48 men (96%) had 36-month data for review. Prior to 12 months, 1 patient had proceeded to radical prostatectomy (treatment failure), 12 patients (24%) underwent per-protocol second hemi-ablation for GG2 found at 3-month biopsy and 1 patient died due to COVID19. 20 patients underwent a subsequent MRI and biopsy. 1 patient had in-field GG3 at 2yr biopsy and underwent cryoablation. At 34 months, two patients underwent biopsy and had GG2; one recurrence was in-field, and one was both in and out of field. Functional outcomes at 36 months post-treatment included a mean decrease in IIEF-6 scores from baseline of 2.6 (±6.3). IPSS demonstrated an average improvement of 1.1 (±4.1); all patients maintained pad-free urinary continence. Overall, 38/48 (79%) evaluable men remained free from evidence of clinical disease progression after 36 months post-treatment. CONCLUSIONS: These positive trial results show that WST11-VTP is effective for PGA of intermediate-risk PC with minimal long-term toxicity and low impact on urinary and sexual function, consistent with the Phase 3 trial results in low-risk disease. Continued follow-up to the protocol defined 5-year endpoint is pending. Based on this data, this therapy bears consideration for approval as a conservative therapeutic option for selected cases of intermediate risk disease. Source of Funding: Steba Biotech © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e412 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Jonathan S. Fainberg More articles by this author Behfar Ehdaie More articles by this author Oguz Akin More articles by this author Timothy Donahue More articles by this author James Eastham More articles by this author Connie Estes More articles by this author Nicholas Fantanza More articles by this author Samson Fine More articles by this author Alvin Goh More articles by this author Kwanghee Kim More articles by this author Vincent Laudone More articles by this author Nicole Liso More articles by this author John P. Mulhall More articles by this author Jamie Petrancosta More articles by this author Jaspreet Sandhu More articles by this author Peter Scardino More articles by this author Avigdor Scherz More articles by this author Susan Slovin More articles by this author Andrew Vickers More articles by this author Jonathan Coleman More articles by this author Expand All Advertisement PDF downloadLoading ...