RecruitingProstate Cancer
PSMA-PET to Guide Prostatectomy
Eligible age
40–80 yrs
Accepts
Men
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.
Sponsor: Five Eleven Pharma, Inc.
You may qualify if…
- ✓ 1. Significant prostate cancer:
- ✓ Gleason 3+4 ≥1 core with pattern 4 ≥20%
- ✓ Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR
- ✓ NCCN unfavorable intermediate risk OR
- ✓ Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND
- ✓ 2. Baseline sexual function (IIEF-EF \> 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
- ✓ 3. The patient desires to maintain erections following treatment
- ✓ 4. Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant.
You may not qualify if…
- ✕ 1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- ✕ 2. Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).
- ✕ 3. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Where it's recruiting
Indiana
Indianapolis
Source: ClinicalTrials.gov · NCT05381103 · last updated 2025-01-31