PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT07550517
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • High-Risk Localized Prostate Cancer

Eligibility Criteria

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

Interventions

  • EBRT + 6 mo ADT + 177Lu-PSMA-617 — DRUG
    In Arm A, 177Lu-PSMA-617 will be given as intravenous infusion every 6 weeks, up to 4 cycles. Cycle 1 Day 1 (C1D1) of 177Lu-PSMA-617 will start at least 2 weeks after ADT, and EBRT will start at least 2 weeks after C1D1.
  • EBRT + 24 mo ADT — RADIATION
    In Arm B, EBRT will start 3-7 weeks after Day 1 of ADT.

Study Details

This research is being done to find out if the study drug, 177Lu-PSMA-617, given before and during standard of care External Beam Radiation Therapy (EBRT) treatment, with a shorter course of Androgen Deprivation Therapy (ADT) (6 months) is (1) safe and effective compared to standard of care alone, and (2) can reduce the side effects caused by long-term (24 months) ADT in men with high risk localized prostate cancer.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2032
Completion
Apr 30, 2033

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (EBRT + 6 mo ADT + 177Lu-PSMA-617)
    Participants will receive EBRT + 6 mo ADT + 177Lu-PSMA-617
  • Active Comparator: Arm B (EBRT + 24 mo ADT)
    Participants will receive EBRT + 24 mo ADT

Primary Outcome Measure

Rate of testosterone recovery (TR) [ Time Frame: Post randomization up to 3 years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287-

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By research site
Johns Hopkins University· Baltimore, MD