PSMA-PET to Guide Prostatectomy

Study Overview
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Brief Summary
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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.

Official Title
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PSMA-PET to Guide Prostatectomy: A Randomized Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: PSMA-PET and SOC MRI
* Diagnostic Test: SOC MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men diagnosed with prostate cancer who choose radical prostatectomy Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% OR ≥3 cores of Gleason 3+4 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 erectile dysfunction OR mild-to-moderate erectile dysfunction (International Index of Erectile Function-Erectile Function domain ≥ 17). AND The patient desires to maintain erections following treatment. Exclusion Criteria: Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days Patient is unable to tolerate remaining still on the bed of the PET or MRI camera, due to physical limitations or claustrophobia. c. Significant acute or chronic medical condition in the subject that could compromise the objectives of the study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSMA-PET and SOC MRI prior to surgery<br> | Diagnostic Test: PSMA-PET and SOC MRI<br>* 60 min continuous acquisition of PET data after 3-6 mCI injection of [68Ga]P16-093 followed by contrast-CT<br>|
| Active Comparator: SOC MRI prior to surgery<br> | Diagnostic Test: SOC MRI<br>* Standard of care MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF-EF sub scale score | International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes. | 1 month | 
| IIEF-EF sub scale score | International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes. | 3 months | 
| IIEF-EF sub scale score | International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes. | 6 months | 
| IIEF-EF sub scale score | International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes. | 12 months | 
| IIEF-EF sub scale score | International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in treatment plan | 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 | 1 month | 
| Ratio of positive surgical margins to nerve bundles spared |  | 1 month | 
| EPE detection | Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles | 1 month | 
| Incontinence bother | Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2 | 18 months | 
| Incontinence: using 0-1 pads per day | Expanded Prostate Cancer Index Composite (EPIC-26) question 3 | 18 months | 
| Urgency/frequency | Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5 | 18 months | 
| Erectile dysfunction: ability to achieve erection sufficient for penetration | IIEF question 3 | 18 months | 
| Overall mental and physical health | Short Form quality of life questionnaire (SF-36) | 18 months | 
| Surgical margins | postive surgical margin rates | 1 month |