Prostate Cancer Clinical Trial
Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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There are 2 Locations for this study
Los Angeles California, 90095, United States
San Francisco California, 94115, United States
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