Status:
RECRUITING
PSMA-PET to Guide Prostatectomy
Lead Sponsor:
Five Eleven Pharma, Inc.
Collaborating Sponsors:
Indiana University
Conditions:
Prostate Cancer
Eligibility:
MALE
40-80 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT05381103
Start Date
October 1 2021
End Date
December 1 2028
Last Update
January 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202