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
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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