What this study is
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.
What's being tested
- PSMA-PET and SOC MRI
Intervention · DIAGNOSTIC TEST
60 min continuous acquisition of PET data after 3-6 mCI injection of [68Ga]P16-093 followed by contrast-CT
- SOC MRI
Intervention · DIAGNOSTIC TEST
Standard of care MRI
Study details
- Official title
- PSMA-PET to Guide Prostatectomy: A Randomized Trial
- Sponsor
- Five Eleven Pharma, Inc.
- Conditions
- Prostate Cancer
- Enrolling
- 288 people
- Starts
- 2021-10-01
- Est. completion
- 2028-12-01
- Design
- Single-blind, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 80 YearsSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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 surgeryExcept: 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openGoodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
Indianapolis, Indiana, United States
- Mark Green, Ph.D · Contact
Recruiting
Study team
Sponsor
Five Eleven Pharma, Inc.
Study ID IU_CLN02_EPE
Principal investigator
Clinton Bahler, MD
Indiana University School of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.