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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: 68Ga-PSMA-11 PET Scan

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

  1. > 3 cores of Gleason 3+4 or
  2. NCCN unfavorable intermediate risk or
  3. NCCN high-risk or
  4. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinton Bahler

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): July 19, 2022

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 19, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: IUSCCC-0760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No