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.
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 with a prior history of prostate cancer treatment.
Patients with previous treatment with PSMA-targeted radioligand therapy or any of the following within 6 months of enrollment confirmation: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation.
Patients with distant disease (outside of local lymph nodes).
Significant bone marrow impairment defined by leukocytes <3,000/mcL, absolute neutrophil count (ANC) <1,500/mcL, and platelet count lower than 70,000/mcL.
Hackensack Meridian Health
Lead sponsor
Lombardi Comprehensive Cancer Center
Collaborator
Novartis
Collaborator