PSMA-PET to Guide Prostatectomy
Conditions
Prostate CancerSummary
In this study, 288 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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Mark Green, Ph.D
Principal Investigator
- Clinton Bahler, MD
Eligibility Criteria
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 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.
5. Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.
Exclusion Criteria:
1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
2. Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).
3. 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.
Outcome Measures
Primary Outcome Measures
IIEF-EF sub scale score
IIEF-EF sub scale score
IIEF-EF sub scale score
IIEF-EF sub scale score
IIEF-EF sub scale score
Secondary Outcome Measures
Change in treatment plan
Ratio of positive surgical margins to nerve bundles spared
EPE detection
Incontinence bother
Incontinence: using 0-1 pads per day
Urgency/frequency
Erectile dysfunction: ability to achieve erection sufficient for penetration
Overall mental and physical health
Surgical margins
Timeline
Last Updated
October 30, 2024Start Date
May 19, 2022Today
January 16, 2025Completion Date ( Estimated )
March 31, 2028
Sponsors of this trial
Lead Sponsor
Five Eleven Pharma, Inc.Collaborating Sponsors
Indiana University