68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer

Status: complete

This clinical trial investigates the effect of 68Ga-PSMA-11 positron emission tomography (PET) in surgery guidance in prostate cancer. The imaging agent, 68Ga-PSMA-11, seeks to identify prostate cancer based on its expression of a specific protein target, prostate-specific membrane antigen (PSMA), which is known to be present at high levels on the surface of most prostate cancer cells. 68Ga-PSMA-11 PET may provide the surgeon with additional information about the cancer’s location that may help guide the surgeon as they attempt to preserve muscle and nerve tissue near the prostate while also attempting to remove all of the cancer. This study aims to look at how well the pre-surgery PET scan predicts the local spread of prostate cancer beyond prostate boundaries.

Inclusion Criteria

Men diagnosed with clinically significant prostate cancer and are scheduling prostatectomy
Prostate pathology results consistent with: * >= 3 cores of Gleason 3+4 or * National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk or * NCCN high-risk or * NCCN very-high risk
Scheduled for standard of care magnetic resonance imaging (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 MRI

Exclusion Criteria

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 this 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

PRIMARY OBJECTIVE:

I. Evaluate PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on the whole-mount pathology gold standard.

SECONDARY OBJECTIVES:

I. 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) right nerve bundle, 3) left nerve bundle, 4) urethral sphincter.

II. Compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.

III. Assess quality of life changes from preoperative baseline: Index for Erectile Function (IEF)-15 (erectile function score), Expanded Prostate Cancer Index Composite (EPIC)-26 (pad use), Short Form (SF)-36 (overall mental and physical health domains).

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV) then undergo PET/computed tomography (CT) over 45 minutes. Patients then undergo surgery.

After completion of study treatment, patients are followed up at 1, 3, 6 months and 1 year.

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68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer

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