Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy

NCT03582774 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2025-05-13

No results posted yet for this study

Summary

This phase III trial studies how well Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT) works in diagnosing participants with prostate cancer that has come back after surgery. 68Ga-PSMA-11 are taken up by cancer cells. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread. Giving 68Ga-PSMA-11 with PET/CT may help doctors plan better for salvage radiation therapy in participants with recurrent prostate cancer.

Conditions

  • Recurrent Prostate Carcinoma

Interventions

OTHER

Best Practice

Undergo standard of care

PROCEDURE

Computed Tomography

Undergo PET/CT

RADIATION

Gallium Ga 68-labeled PSMA-11

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jeremie Calais · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2026-07-12
Completion
2027-07-12
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03582774 on ClinicalTrials.gov