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Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

NCT06084338 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-31

No results posted yet for this study

Summary

This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer.

All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.

Conditions

Interventions

RADIATION

stereotactic ablative radiotherapy

Metastasis directed

DRUG

Pluvicto

PSMA targeted radiopharmaceutical therapy

DRUG

topical testosterone

Topical testosterone 1.62% gel

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Nicholas George Nickols, MD PhD · VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2027-11-29
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06084338 on ClinicalTrials.gov