Expanding Indication Of Padeliporfin (Wst11) Vascular-Targeted Photodynamic Therapy: Results Of Prostate Cancer Latin-American Multicenter Study

Objectives: To explore the proportion of patients with higher risk localized prostate cancer (PCa) that would become safely biopsy negative 12 months after non-thermal focal therapy with padeliporfin vascular-targeted photodynamic therapy (VTP).Methods: Multicenter study in a scenario of prostate-specific antigen (PSA) <= 20 ng/ml and variable PCa target volumes Gleason pattern 3 or low-volume secondary Gleason pattern 4, all patients received VTP, consisting of intravenous 4 mg/kg padeliporfin activated by light-diffusing fibers in the prostate. The prostate was biopsied at baseline, months 6 and 12, PSA, patient-reported functional outcomes and quality of life (QoL) questionnaires were recorded at baseline, months 3, 6, and 12 and adverse events (AE) throughout the study.Results: In the intention-to-treat population (n = 81), the proportion of patients with negative biopsies at month 12 was 74% (60/81 patients; 95% CI: 63.1%, 83.2%). In the per-protocol population, the proportion was 79% (58/73 patients; 95% CI: 68.4%, 88.0%). Questionnaire results indicated a slight improvement in urinary function and limited deterioration in sexual function. No difference in QoL was observed over time. A total of 42/81 (52%) patients reported mild or moderate and 4 of 81 (4.9%) experienced serious AE, all resolved without sequelae. No phototoxicity, cardiovascular event, fistula or prolonged urinary incontinence, secondary cancer or death was reported.Conclusions: Results support the efficacy, safety, and QoL associated with padeliporfin focal treatment for low/intermediate risk localized PCa. (C) 2018 AEU. Published by Elsevier Espana, S.L.U. All rights reserved.