A Single-Arm, Open-Label, Prospective, Phase 0 Trial Evaluating the Safety and Efficacy of Salvage 177Lu-PSMA-I&T in Prostate Specific Antigen (PSA) Biochemical Failure After Radical Prostatectomy for High-Risk Prostate Cancer

The primary objective is to determine the serum PSA response following a single cycle of 177Lu-PSMA-I&T at 3-months in men with undetectable PSA biochemical failure after radical prostatectomy.

This study aims to assess whether a single dose of 177 Lutetium-PSMA-targeted therapy is safe and effective as a treatment for men who have developed biochemical failure after having a radical prostatectomy. Who is it for? You may be eligible for this study if you are a male aged 18 years or older who has recently undergone a radical prostatectomy (surgery to remove the prostate) due to a diagnosis of high or very high risk prostate cancer. Participants will undergo blood tests and MR imaging to determine whether they meet the additional criteria of biochemical failure. Study details All participants who choose to enrol in this study will receive a single dose of 177 Lutetium-PSMA-targeted therapy that will be administered intravenously (through a vein). Please note that any participants who are eligible for this study will need to pay out-of-pocket for the study treatment (177-Lu-PSMA-I&T) as well as the post-operative mpMRI (multiparametric Magnetic Resonance Imaging of the prostate). It is anticipated that the single dose will be administered over a 10-minute period followed by a saline (neutral fluid) flush. Participants will then be asked to provide blood samples at 3 months post-dose, and then every 4 months for up to 3 years post-dose. Participants will also be asked to complete a questionnaire about their health at 30 days, and then every 3-6 months for up to 3 years post-dose. Additional imaging scans will also be collected at 3 months post-dose, with the potential for further imaging to be determined by the treating clinician. It is hoped this research will determine whether a single dose of 177 Lutetium-PSMA-targeted therapy is safe and whether it has a positive impact on resistant prostate cancer. If this study does show that the drug is safe and effective, a larger study to examine potential benefits in more patients may proceed.