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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936334
• Other study ID #: IUSCCC-0760
• Status: Completed
• Phase: Phase 2
• Start date: June 11, 2021
• Est. completion date: July 19, 2022

Study information

• Verified date: August 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 19, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University Health University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Clinton Bahler

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET	Rate of treatment changes	60 Days