Back to resultsExpanded Access [Ga-68] PSMA-11 PET Imaging
Primary Purpose
Prostate Cancer
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
[Ga-68] PSMA-11 PET/CT
[Ga-68] PSMA-11 PET/MR
Sponsored by
About this trial
This is an expanded access trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04800068
Brief Title
Expanded Access [Ga-68] PSMA-11 PET Imaging
Official Title
Expanded Access [Ga-68] PSMA-11 PET Imaging
Study Type
Expanded Access
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
5. Study Description
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 prostate cancer and at the time of biochemical recurrence. In addition, available data show superiority of metastatic lesion detection with [Ga-68] PSMA-11 PET over conventional imaging. This improved lesion detection has a direct impact on selection of anti-cancer therapy and thus may improve patient outcomes.
Under expanded access IND, enrolled patients will receive a clinical [68Ga] PSMA-11 PET/CT or PET/MR for evaluation of their cancer. Imaging exams must be deemed clinically indicated by a referring provider. Patients will be responsible for the cost of the imaging exam. Access is limited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
[Ga-68] PSMA-11 PET/CT
Intervention Description
Imaging scan
Intervention Type
Diagnostic Test
Intervention Name(s)
[Ga-68] PSMA-11 PET/MR
Intervention Description
Imaging scan
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials.
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Expanded Access [Ga-68] PSMA-11 PET Imaging
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