Status:
NO_LONGER_AVAILABLE
Expanded Access [Ga-68] PSMA-11 PET Imaging
Lead Sponsor:
Mayo Clinic
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
In this expanded access IND study, Mayo Clinic in Rochester MN offers \[Ga-68\] PSMA-11 PET/CT or PET/MR imaging to patients who meet criteria.
Detailed Description
\[Ga-68\] PSMA-11 PET/CT and PET/MR imaging has been shown to allow for accurate detection of metastatic prostate cancer at the time of initial diagnosis and staging of patients with high-risk prostat...
Eligibility Criteria
Inclusion
- Participant Groups
- There are two participant groups; please refer to the inclusion details below:
- Group 1: Untreated High-Risk prostate cancer group (must meet at least one of the following inclusion criteria):
- Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more
- Pathologic criteria of International Society of Uropathology (ISUP) grade group 3-5 (ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10)
- Local staging of T3 or worse (Indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI)
- Biochemically Recurrent prostate cancer group (must meet one of the criteria):
- In patients who have undergone a prostatectomy, PSA \> 0.2 ng/ml on 2 consecutive tests
- In patients who have undergone definitive prostate radiation, PSA rise ≥ 2 ng/mL above the nadir PSA
- Exclusion Criteria: Current exclusion criteria for both groups includes:
- Patients unable to sign informed consent
- Patient with a life expectancy less than 6 months
- Additional exclusion criteria may be added based on demand
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04800068
Last Update
January 21 2022
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905