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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Hackensack Meridian Health
Study ID
NCT06798558
Phase
PHASE2
Status
Recruiting
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Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lu-17-PSMA-617 — DRUG
    Lu-17-PSMA-617 administration

Study Details

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.

Key Dates

Start date
Mar 5, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Prostate cancer down-staging following treatment with Lu-177-PSMA-617 (PluvictoⓇ) defined by Gleason Grade Group [ Time Frame: Patients will undergo a PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington D.C.District of Columbia20057
Paul Leger, MD (PRINCIPAL_INVESTIGATOR)
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Ross Krasnow, MD (PRINCIPAL_INVESTIGATOR)
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601
Nitin Yerram, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center· Washington D.C., DCMedStar Washington Hospital Center· Washington D.C., DCJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJ

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