Status:
COMPLETED
PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
Lead Sponsor:
Indiana University
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low ...
Detailed Description
This is a prospective, single arm, phase 2 clinical trial. This patient population will have low (1 = Gleason 3 + 3) or intermediate risk (2 = 3 + 4; 3 = 4 + 3) prostate cancer. It will also enroll th...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Must provide written informed consent
- Presence of low or intermediate risk prostate cancer or at risk of having intermediate risk cancer
- a. Intermediate risk prostate cancer: i. Grade group 2 = 3 + 4, or ii. Grade group 3 = 4 + 3 b. At Risk of intermediate risk prostate cancer: i. 4K score ≥ 20%, or ii. Select MDx ≥ 20%, or iii. PSA Density ≥ 0.15 iv. Grade group 1= 3+3 (iv. Note: Where multiple cancer lesions are present on biopsy, it is allowable to have Gleason 8 or 9 cancer lesions if they are in addition to the intermediate risk cancer as described above.)
- Scheduled for MRI or has recently completed SOC MRI (within 6 months) for further biopsy, or surgical removal, or focal therapy.
- Willing and able to lie still for approximately 50 minutes in an enclosed space for the CT.
Exclusion
- Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed).
- Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03429244
Start Date
April 15 2019
End Date
May 1 2022
Last Update
May 8 2023
Active Locations (4)
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1
Indiana University Health North Hospital
Carmel, Indiana, United States, 46032
2
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
3
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
4
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202