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

NCT07550517 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-24

No results posted yet for this study

Summary

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.

Conditions

  • High-Risk Localized Prostate Cancer

Interventions

DRUG

EBRT + 6 mo ADT + 177Lu-PSMA-617

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.

RADIATION

EBRT + 24 mo ADT

In Arm B, EBRT will start 3-7 weeks after Day 1 of ADT.

Sponsors & Collaborators

Principal Investigators

  • Ana Kiess · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2032-04-30
Completion
2033-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07550517 on ClinicalTrials.gov