Phase II Study of Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 Kettering Male Life Expectancy tool:

∙ https://www.mskcc.org/nomograms/prostate

• If using a life expectancy table, life expectancy should be adjusted using the clinician's assessment of overall health as follows: best quartile of health - add 50%; worst quartile of health - subtract 50%; and middle two quartiles of health - no adjustment. See the NCCN Prostate Cancer Guidelines for more information.

‣ Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

⁃ Patients who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:

• With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for 14 weeks after the final dose of study treatment. Men must refrain from donating sperm during this same period.

• With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 14 weeks after the final dose of study treatment to avoid potential exposure to the embryo.

• The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.

‣ Patients who are able to comply with follow-up visits and treatment plans.

⁃ Patients who are able to give informed consent.

Locations
United States
Washington, D.c.
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
NOT_YET_RECRUITING
Washington D.c.
MedStar Washington Hospital Center
NOT_YET_RECRUITING
Washington D.c.
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
Contact Information
Primary
Oncology Clinical Research Referral Office
OncologyResearchReferral@hmhn.org
551-996-1777
Time Frame
Start Date: 2025-03-05
Estimated Completion Date: 2029-03
Participants
Target number of participants: 54
Treatments
Experimental: Lu-177-PSMA-617 Treatment
Patients will receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week)
Related Therapeutic Areas
Sponsors
Collaborators: Lombardi Comprehensive Cancer Center, Novartis
Leads: Hackensack Meridian Health

This content was sourced from clinicaltrials.gov