Comparing Carboplatin and Cabazitaxel versus 177Lu-PSMA-617 for Treating Aggressive Metastatic Castrate-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating treatments for metastatic castrate-resistant prostate cancer mCRPC in participants whose cancer no longer responds to hormone therapy and docetaxel, and who have prostate-specific membrane antigen PSMA positive tumors. This phase 2 trial aims to determine which treatment works best among options including cabazitaxel combined with carboplatin versus 177Lu-PSMA-617. The study addresses the challenge of finding effective therapies as mCRPC typically has a poor prognosis with limited survival despite available treatments. Participants will be randomly assigned to receive either cabazitaxel with carboplatin or 177Lu-PSMA-617. The cabazitaxel and carboplatin regimen involves intravenous infusions every three weeks for up to 10 cycles or until disease progression or unacceptable side effects occur. The 177Lu-PSMA-617 treatment is given intravenously every six weeks for up to 6 cycles or until progression or toxicity. Both treatments are investigational in this setting and administered under medical supervision. During the study, participants will undergo evaluations including PSA blood tests to measure treatment response at baseline and 12 weeks after starting treatment. Additional outcomes monitored include progression-free survival and time until the need for next cancer therapy. Researchers will also assess safety and tolerability. The study duration varies by participant depending on treatment cycles and disease progression, with regular clinical assessments to monitor health and treatment effects throughout the trial period.

Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer