Phase 3 Study Comparing Standard and Adaptive Dosing of Lutetium 177 Lu PSMA Radioligand Therapy in Advanced Hormone-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating whether adjusting the timing of doses for the prostate cancer drug Lutetium 177 Lu PSMA RLT can improve quality of life without reducing lifespan in patients with hormone-resistant prostate cancer that may have spread nearby or to distant sites. This phase III trial compares the standard dosing schedule with an adaptive dosing approach based on disease activity. The study focuses on patients whose cancer cells express a protein called PSMA, which the drug targets. Participants first receive two doses of Lutetium 177 Lu PSMA RLT intravenously every 6 weeks. Those showing sufficient PSA decline then enter a randomized phase where one group continues standard dosing every 6 weeks for up to four more doses, while the other group has treatment delayed and resumed adaptively based on PSA levels and clinical signs. Throughout the trial, patients undergo blood tests, CT scans, bone scans, PSMA PET scans during screening, and MRI if indicated. Treatment continues unless disease progresses or unacceptable side effects occur. During the study, participants have regular PSA monitoring, blood samples collected, and imaging tests to assess disease status and side effects. Quality of life, overall survival, pain severity, and treatment toxicity are measured up to several years. After treatment, patients are followed every 12 weeks until disease progression and then every 6 months for up to 5 years. The study aims to understand if adaptive dosing can maintain survival while improving life quality for men with advanced prostate cancer.

Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial