Clinical Trial · NCT04936334

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

Overview

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.

Sponsor

Indiana University

Phase

Phase 2

ClinicalTrials.gov

NCT04936334

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Eligibility

Inclusion

NCCN unfavorable intermediate risk or
\> 3 cores of Gleason 3+4 or
1\. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:
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

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.