The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer

Study Overview
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Brief Summary
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Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard). Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4). Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments. Assess quality of life changes from preoperative baseline.

Official Title
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The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: 68Ga-PSMA-11 PET Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with: > 3 cores of Gleason 3+4 or NCCN unfavorable intermediate risk or NCCN high-risk or NCCN very-high risk 3. Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months). Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI 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 could affect prostate imaging). 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.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy<br>1. Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery | Diagnostic Test: 68Ga-PSMA-11 PET Scan<br>* Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension | Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles | The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery. | 
| Specificity of PSMA-PET and MRI | Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard. | Pre-surgery prediction. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET | Rate of treatment changes | 60 Days |