UpFrontPSMA: A randomized phase II study of sequential 177Lu-PSMA617 and docetaxel versus docetaxel in metastatic hormone-naive prostate cancer (mHNPC).
Arun Azad, Nattakorn Dhiantravan, Louise Emmett, Anthony M Joshua, Ian Vela, David A Pattison, Roslyn J Francis, Scott Williams, Shahneen Kaur Sandhu, Ian D Davis, Nitika Neha, Mathias Bressel, Declan G Murphy, Michael S Hofman
JOURNAL OF CLINICAL ONCOLOGY | LIPPINCOTT WILLIAMS & WILKINS | Published : 2021
TPS180 Background: 177Lu‐PSMA-617 (Lu-PSMA) is a radiolabeled small-molecule that binds with high affinity to PSMA enabling highly targeted delivery of beta radiation to prostate cancer cells. In metastatic castration-resistant prostate cancer, Lu-PSMA showed superior activity to Cabazitaxel in the TheraP trial. Although androgen deprivation therapy (ADT) + Docetaxel is a standard of care for de novo high-volume mHNPC, outcomes remain sub-optimal for many patients. We hypothesize that Lu-PSMA prior to docetaxel will achieve a higher undetectable PSA rate at 12 months compared to docetaxel alone in men with newly-diagnosed high-volume mHNPC. Methods: UpFrontPSMA is an open label, randomized,..View full abstract
Up Front PSMA is an investigator-led, academic trial sponsored by Peter MacCallum Cancer Centre in collaboration with ANZUP Cancer Trials Group with study coordination provided by the Centre for Biostatistics and Clinical Trials (BaCT) Clinical trial information: NCT04343885.