PSMA-PET to Guide Prostatectomy: A Randomized Trial
Five Eleven Pharma, Inc.
Summary
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.
Eligibility
- Age range
- 40–80 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 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 w…
Interventions
- Diagnostic TestPSMA-PET and SOC MRI
60 min continuous acquisition of PET data after 3-6 mCI injection of \[68Ga\]P16-093 followed by contrast-CT
- Diagnostic TestSOC MRI
Standard of care MRI
Location
- Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of MedicineIndianapolis, Indiana