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.
Single group
Lu-17-PSMA-617
DrugLu-17-PSMA-617 administration
Prostate cancer down-staging following treatment with Lu-177-PSMA-617 (PluvictoⓇ) defined by Gleason Grade Group
Staging of prostate cancer is based on the correlation to Gleason Grade Group (GG) according to the American Joint Committee on Cancer (AJCC; 8TH edition, 2017) staging system for prostate cancer (see Appendix A). Prostate cancer downstaging is defined as the post-treatment stage less than the pre-treatment stage. Different downstaging thresholds will be applied including: * Complete downstaging (CD) is defined as no visible tumor in surgical sample; * Good response (GR) is defined as downstaging from high risk disease (GG4 or greater) to intermediate risk pathologic disease (GG2 or GG3 disease); and * Very good response (VGR) is defined as downstaging from high-risk disease (GG4 or greater) to low risk pathologic disease (GG1 disease).
Prostate cancer down-staging following treatment with Lu-177-PSMA-617 (PluvictoⓇ) as defined by margin status, T staging, and seminal vesicle involvement
Staging of prostate cancer is based on the American Joint Committee on Cancer (AJCC; 8TH edition, 2017) combining the TNM staging system for prostate cancer with the Gleason Grade Group (GG)
Decrease in PSMA-avid tumor load
Decrease in PSMA-avid tumor load is measured by comparing the extent of PSMA-avid tumor before and after Lu-177-PSMA-617 (PluvictoⓇ). High PSMA-avidity is defined as more than 2 times the liver activity. Low PSMA-avidity is defined as less than 2 times liver activity. The volumes of PSMA-avid disease will be summed up to quantify the extent of PSMA-avid tumor load before and after Lu-177-PSMA-617 (PluvictoⓇ). PSMA-positive disease is measured using 68Ga-PSMA-11 PET/CT scan.
Safety of radical prostatectomy assessed by surgical delay time
The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the surgical delay time. Surgical delay time is defined as days between the last dose of Lu-177-PSMA-617 (PluvictoⓇ) and the date of radical prostatectomy. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.
Safety of radical prostatectomy assessed by rate of intraoperative and postoperative complications
The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the rate of intraoperative and postoperative complications. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.
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Hackensack Meridian Health
Lead sponsor
Lombardi Comprehensive Cancer Center
Collaborator
Novartis
Collaborator
