PSMA-PET to Guide Prostatectomy: A Randomized Trial
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.
• 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
• Baseline sexual function (IIEF-EF \> 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
• The patient desires to maintain erections following treatment
• 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.
• Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.