Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jonsson Comprehensive Cancer Center
With
National Cancer Institute (NCI)
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.
Age
Any age
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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 may not be 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.
Clareo Health | Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy
