Actively Recruiting
Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
Led by Hackensack Meridian Health · Updated on 2026-03-23
54
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
H
Hackensack Meridian Health
Lead Sponsor
L
Lombardi Comprehensive Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients age 18 or older.
- Histologically confirmed adenocarcinoma of the prostate.
- High-risk disease with preoperative Gleason Score 8 (Grade group 4) or higher.
- Positive PSMA PET/CT scan with high expression in prostate (greater than liver) and no other FDG-positive sites outside prostate.
- Eligible for and willing to undergo radical prostatectomy with pelvic lymph node dissection.
- Life expectancy greater than 10 years, estimated using approved life expectancy tools and adjusted for overall health.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Agree to remain abstinent or use effective contraception and refrain from sperm donation during treatment and for 14 weeks after final dose.
- Able to comply with follow-up visits and treatment plans.
- Able to give informed consent.
You will not qualify if you...
- Prior history of prostate cancer treatment.
- Previous PSMA-targeted radioligand therapy or certain radiotherapies within 6 months.
- Presence of distant metastatic disease beyond local lymph nodes.
- Significant bone marrow impairment (leukocytes <3,000/mcL, ANC <1,500/mcL, platelets <70,000/mcL).
- Significant liver function impairment (total bilirubin >1.5x ULN, ASL/ALT >3x ULN).
- Impaired kidney function (GFR <40 mL/min) or use of nephrotoxic drugs.
- Significant comorbidities making surgery unsafe.
- Evidence of metastatic disease such as enlarged lymph nodes outside local area or distant metastases.
- History of radiation or hormone therapy to the prostate.
- History of bleeding disorders or current anticoagulant therapy.
- Active infections or other contraindications for surgery.
- Unable or unwilling to give informed consent or comply with study requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
2
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20057
Not Yet Recruiting
3
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
O
Oncology Clinical Research Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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