Study of Abemaciclib Followed by 177Lu-PSMA-617 to Treat Metastatic Castration-Resistant Prostate Cancer Previously Treated With Hormonal Agents and Chemotherapy

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of abemaciclib before lutetium Lu 177 vipivotide tetraxetan 177Lu-PSMA-617 in treating patients with metastatic castration resistant prostate cancer mCRPC that has spread to other parts of the body. This phase III study focuses on how abemaciclib, a kinase inhibitor targeting proteins involved in cancer cell growth, may enhance the effect of 177Lu-PSMA-617, a radioligand therapy that delivers targeted radiation to tumor cells expressing the PSMA receptor. Participants receive abemaciclib orally twice daily for 14 days followed by an intravenous infusion of 177Lu-PSMA-617 on day 15. This treatment cycle repeats every 6 weeks for up to 4 cycles, unless disease progresses or unacceptable side effects occur. The study includes dose escalation to determine the recommended phase II dose and evaluates changes in tumor PSMA uptake using PET scans. After treatment, participants enter a follow-up period including a visit 30 days later and long-term survival monitoring every 3 months. Throughout the study, patients undergo scans, blood tests, biopsies, and symptom assessments to measure treatment effects and safety. Researchers track PSA levels, tumor responses, progression-free survival, and overall survival. They also study changes in tumor biology and PSMA expression before and after treatment. Safety is monitored using standard criteria, and participants continue under observation until study conclusion or withdrawal.

Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer