68Ga-PSMA-11 PET / CT in Diagnosing Participants with Recurrent Prostate Cancer After Radical Prostatectomy
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.
- 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.
- Extra-pelvic metastasis on any imaging or biopsy.
- Prior prostate-specific membrane antigen (PSMA) PET/CT.
- Prior pelvic external beam radiation therapy (RT).
- 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.
Locations & Contacts
Contact: Jeremie Calais
Trial Objectives and Outline
I. Success rate of salvage radiation therapy (SRT) measured as biochemical progression-free survival after initiation of SRT.
I. 5-year biochemical progression-free survival rate (from date of initiation of SRT).
II. Metastasis free survival.
III. Initiation of additional salvage therapy after completion of SRT.
IV. 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 at 1-3 days and periodically for up to 5 years.
Trial Phase & Type
No phase specified
UCLA / Jonsson Comprehensive Cancer Center
Secondary IDs NCI-2018-01518, NUC MED 18-000484
Clinicaltrials.gov ID NCT03582774