TheraP: A randomized phase II trial of [177Lu]-PSMA-617 theranostic versus cabazitaxel in progressive metastatic castration-resistant prostate cancer.

• DOI: 10.1200/jco.2019.37.7_suppl.tps332
• Publication Date: 2019-03-07T21:26:33Z
• Authors: Michael Hofman; Louise Emmett; John A Violet; Nicola Jane Lawrence; Scott Williams; Martin R. Stockler; Roslyn J Francis; Amir Iravani; Alison Yan Zhang; Andrew James Martin; Arun Azad; Sonia Yip; Ailsa Langford; Margaret Mary McJ...; Ian D. Davis
• Keywords: Cabazitaxel; Clinical endpoint; Tolerability

TPS332 Background: Lutetium-177 [ 177 Lu]-PSMA-617 is a novel radiolabelled small molecule that binds with high affinity to prostate-specific membrane antigen (PSMA), which commonly overexpressed in prostate cancer. This treatment has demonstrated promising activity and tolerability men progressing after multiple lines of chemotherapy endocrine therapy. trial will determine the safety Lu-PSMA-617 compared cabazitaxel progressive metastatic castrate resistant Methods: TheraP an open-label, randomised, two-arm, multi-centre, phase 2 comparing experimental versus standard nd line cabazitaxel. Key eligibility criteria include prior docetaxel; rising serum PSA; sufficient PSMA avidity according central reviewed imaging PET/CT FDG PET/CT; no discordance between PET PET. The 200 participants randomised 1:1 ratio either intravenously every 6 weeks, 8.5 GBq for cycle 1, decreasing by 0.5 each subsequent cycle, up maximum cycles (experimental group); or, (20 mg/m ) 3 10 (standard group). In event exceptional response Lu]-PSMA-617, centrally-reviewed, post-therapy SPECT imaging, suspended but can recommence subsequently on progression. primary endpoint 50% or greater reduction from baseline PSA. Secondary endpoints overall survival, progression-free survival (PFS), PSA-PFS, pain-PFS, radiographic-PFS, health-related quality life, pain response, adverse events. outcomes patients excluded because discordant disease be reported as tertiary objective. study accrued 79 planned 29 January 2018 23 October 2018. Clinical information: NCT03392428.