Journal article
TheraP: a randomized phase 2 trial of 177Lu-PSMA-617 theranostic treatment vs cabazitaxel in progressive metastatic castration-resistant prostate cancer (Clinical Trial Protocol ANZUP 1603)
MS Hofman, L Emmett, J Violet, A Y. Zhang, NJ Lawrence, M Stockler, RJ Francis, A Iravani, S Williams, A Azad, A Martin, M McJannett, ID Davis
BJU International | WILEY | Published : 2019
DOI: 10.1111/bju.14876
Abstract
Objective: To assess the activity and safety of cabazitaxel chemotherapy vs that of treatment with 177Lu-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 177Lu-PSMA-617 therapy in the treatment of men with mCRPC. Key eligibility criteria include prior docetaxel chemotherapy, rising prostate-specific antigen (PSA) level..
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Awarded by Novartis
Funding Acknowledgements
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.