PSMA-PET to Guide Prostatectomy
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: PSMA-PET and SOC MRIDiagnostic Test: SOC MRI
- Registration Number
- NCT05381103
- Lead Sponsor
- Five Eleven Pharma, Inc.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 288
-
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
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PSMA-PET and SOC MRI prior to surgery PSMA-PET and SOC MRI - SOC MRI prior to surgery SOC MRI -
- Primary Outcome Measures
Name Time Method IIEF-EF sub scale score 18 months International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
- Secondary Outcome Measures
Name Time Method Surgical margins 1 month postive surgical margin rates
Change in treatment plan 1 month Proportion of patients whose treatment plan would be changed by PSMA-PET. Treatment changes are defined as any change in surgical resection plan that affects one of 4 critical regions for quality of life
Ratio of positive surgical margins to nerve bundles spared 1 month EPE detection 1 month Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles
Incontinence bother 18 months Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2
Incontinence: using 0-1 pads per day 18 months Expanded Prostate Cancer Index Composite (EPIC-26) question 3
Urgency/frequency 18 months Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5
Erectile dysfunction: ability to achieve erection sufficient for penetration 18 months IIEF question 3
Overall mental and physical health 18 months Short Form quality of life questionnaire (SF-36)
Trial Locations
- Locations (1)
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States