Hackensack Meridian Health
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.
The PRELUDE trial is a prospective, non-randomized, single-arm, phase 2 interventional study to assess the oncological outcomes after 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at 6-week intervals before prostatectomy in patients with high risk localized prostate cancer. Patients who meet all the inclusion criteria for the study will be enrolled to receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week). Six weeks after the second cycle of Lu-177-PSMA-617 (PluvictoⓇ), patients will be eligible for radical prostatectomy…
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 p…
Lu-17-PSMA-617 administration
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