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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: 68Ga-PSMA-11 PET Scan

• Registration Number: NCT04936334
• Lead Sponsor: Clinton Bahler

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-11
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-19
• Study First Posted: 2021-06-23
• Primary Completion: 2022-07-18
• Study Completion: 2022-07-19
• Results First Submitted: 2023-05-16
• Results First Submitted QC: 2023-07-26
• Results First Posted: 2023-07-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

Inclusion Criteria

• 1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:

  2. > 3 cores of Gleason 3+4 or

  3. NCCN unfavorable intermediate risk or

  4. NCCN high-risk or

  5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy	68Ga-PSMA-11 PET Scan	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

Primary Outcome Measures

Name	Time	Method
Specificity of PSMA-PET and MRI	Pre-surgery prediction.	Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.
Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension	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.	Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles

Secondary Outcome Measures

Name	Time	Method
1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET	60 Days	Rate of treatment changes

Trial Locations

Locations (1)

Indiana University Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States