TheraP: a randomized phase 2 trial of Lu-177-PSMA-617 theranostic treatment vs cabazitaxel in progressive metastatic castration-resistant prostate cancer (Clinical Trial Protocol ANZUP 1603)
Michael S Hofman, Louise Emmett, John Violet, Alison Y Zhang, Nicola J Lawrence, Martin Stockler, Roslyn J Francis, Amir Iravani, Scott Williams, Arun Azad, Andrew Martin, Margaret McJannett, Ian D Davis
BJU International | WILEY | Published : 2019
OBJECTIVE: To assess the activity and safety of cabazitaxel chemotherapy vs that of treatment with 177 Lu-PSMA-617, a novel radiolabelled small molecule that binds with high affinity to prostate-specific membrane antigen (PSMA), in men with metastatic castration-resistant prostate cancer (mCRPC) who have received prior docetaxel treatment. PATIENTS AND METHODS: The TheraP trial (ANZUP 1603) is an open-label, randomized, stratified, two-arm multicentre phase 2 trial comparing the activity and safety of cabazitaxel chemotherapy vs 177 Lu-PSMA-617 therapy in the treatment of men with mCRPC. Key eligibility criteria include prior docetaxel chemotherapy, rising prostate-specific antigen (PSA) lev..View full abstract
Awarded by NHMRC Practitioner Fellowship
TheraP is a partnership between the ANZUP Trials Group and the Prostate Cancer Foundation of Australia (PCFA) with support from the Australian Nuclear Science and Technology Organisation (ANSTO), Endocyte Inc., a Novartis Company, Movember, The Distinguished Gentleman's Ride, It's a Bloke Thing and CAN4CANCER. Michael Hofman is supported by a Clinical Fellowship from the Peter MacCallum Foundation. Ian Davis is supported by an NHMRC Practitioner Fellowship (APP1102604). ANZUP acknowledges funding from Support for Cancer Clinical Trial program, Cancer Australia.