Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
Trial Parameters
Brief Summary
Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperative prostate biopsy score of Gleason 8 (GS8) (Grade group 4 \[GG4\]) or higher. Patients also need to have a positive PSMA scan on 68-Ga-PSMA-11 PET/CT scan.
Eligibility Criteria
Inclusion Criteria: * Patients age 18 or older. * Patients with histologically confirmed adenocarcinoma of the prostate. * Patients with high-risk disease defined as a preoperative prostate biopsy of Gleason Score 8 (GS8) (Grade group 4 \[GG4\]) or higher. Men with evidence of lymph node involvement at or below the bifurcation of the common iliac arteries (cN1) on PET-CT 68Ga-PSMA-11 are eligible. * Pre-operative, pre-treatment PSMA scan with high expression in prostate confirmed by PET/CT 68Ga-PSMA-11 (greater than liver). Patients must not have any other PET FDG-positive sites outside the prostate. * Patients who are able and willing to undergo surgery. * Patients with a life expectancy of greater than 10 years. Life expectancy can be estimated using any 1 of the following tools: * The Social Security Administration tables: https://www.ssa.gov/OACT/STATS/table4c6.html * The WHO's Life Tables by country: https://apps.who.int/gho/data/view.main.60000?lang=en * The Memorial Sloan Ketter