for males (full criteria)
at San Francisco, California and other locations
study started
estimated completion



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.

Official Title

Phase III Randomized Multicenter Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]


PRIMARY OBJECTIVE: I. Success rate of salvage radiation therapy (SRT) measured as biochemical progression-free survival after initiation of SRT. SECONDARY OBJECTIVES: I. Sub-group analysis of the primary endpoint (success rate of SRT) within the subgroup with baseline PSA ≥ 0.5 ng/ml II. 5-year biochemical progression-free survival rate (from date of randomization). III. Metastasis free survival. IV. Initiation of additional salvage therapy after completion of SRT. V. Change in initial treatment intent. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive standard of care SRT. ARM II: Participants receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist. After conclusion of PET/CT, participants are followed up periodically for up to 5 years.


Recurrent Prostate Carcinoma, PSMA, PET/CT, salvage radiation therapy, randomized trial, Prostatic Neoplasms, Edetic Acid, Gallium 68 PSMA-11, Best Practice, Computed Tomography, Gallium Ga 68-labeled PSMA-11, Positron Emission Tomography


You can join if…

Open to males

  • Histopathology proven prostate cancer.
  • Planned SRT for recurrence after primary prostatectomy.
  • Prostate-specific antigen (PSA) >= 0.1 ng/ml at time of enrollment.
  • Willingness to undergo radiotherapy.
  • Treating radiation oncologist intends to incorporate 68Ga-PSMA-11 PET/CT findings into the radiotherapy plan if patient undergoes 68Ga-PSMA-11 PET/CT.

You CAN'T join if...

  • Extra-pelvic metastasis on any imaging or biopsy.
  • Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT.
  • Contraindications to radiotherapy (including active inflammatory bowel disease).
  • Concurrent systemic therapy for prostate cancer with investigational agents.


  • UCSF Medical Center-Mount Zion
    San Francisco California 94115 United States
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles California 90095 United States


in progress, not accepting new patients
Start Date
Completion Date
Jonsson Comprehensive Cancer Center
Phase 3 Prostate Cancer Research Study
Study Type
Expecting 193 study participants
Last Updated