PSMA-PET to Guide Prostatectomy
Recruiting · NCT05381103 · Interventional (participants receive a specific treatment) · Lead sponsor: Five Eleven Pharma, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PSMA-PET and SOC MRISOC MRI
What this trial is about
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.
Who can take part
Age range
40 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
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, since MRI is required for comparison).
- 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 is running
1 location listed across 1 US state.
- Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine - Indianapolis, Indiana, United States