PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
Prostate Cancer
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- ≥ 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 Criteria:
- 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.
Sites / Locations
- Indiana University Health North Hospital
- Indiana University Health Hospital
- Indiana University Health Methodist Hospital
- Indiana University Melvin and Bren Simon Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Prostate cancer- men being treated with radical prostatectomy
Prostate cancer- men undergoing cancer screening or active surveillance
Prostate cancer- focal therapy
Men being treated for prostate cancer with radical prostatectromy were enrolled in this arm.
Men undergoing cancer screening or active surveillance were enrolled in this arm.
Men undergoing focal therapy with high intensity focused ultrasound are in this group.