An Early Phase 1 interventional study of Ga-68 PSMA11 and F-18 PSMA 1007 in Prostate Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Mayo Clinic · Early Phase 1, Interventional, and Diagnostic
Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 250 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. > 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)
Exclusion Criteria:
Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT
Drug: Ga-68 PSMA11
F-18 Labeled PSMA 1007 PET/CT
Drug: F-18 PSMA 1007
Ga-68 PSMA11 PET/CT for detection of tumor location
F-18 PSMA 1007 PET/CT for detection of tumor location
Tumor Detection on PET/CT
Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.
Time frame: 12 Months post PET/CT
Impact of PSMA and C-11 choline PET on clinical management
Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management
Time frame: 12 Months
Incidence of adverse events attributable to PSMA
Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Time frame: 12 Months
Plan to share: Yes — The IPD data from this trial will be available to other researchers that will collate similar data from multiple sites to provide data to the FDA.
Supporting information: Study protocol, Csr
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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