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

NCT04936334 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IUSCCC-0760
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET

  60 Days

Study Arms (1)

Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy

EXPERIMENTAL

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

Interventions

68Ga-PSMA-11 PET Scan DIAGNOSTIC_TEST

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.

Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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 could affect prostate imaging).
• \. 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.

Sponsors & Collaborators

• Clinton Bahler: lead

Study Sites (1)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Bahler CD, Tachibana I, Tann M, Collins K, Swensson JK, Green MA, Mathias CJ, Tong Y, Yong C, Boris RS, Brocken E, Hutchins GD, Sims JB, Hill DV, Smith N, Ferari C, Love H, Koch MO. Comparing Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen-Positron Emission Tomography for Prediction of Extraprostatic Extension of Prostate Cancer and Surgical Guidance: A Prospective Nonrandomized Clinical Trial. J Urol. 2024 Aug;212(2):290-298. doi: 10.1097/JU.0000000000004032. Epub 2024 May 24.

  PMID: 38785259 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Jennifer Lehman, RN, Senior Research Leader
• Organization: Indiana University, Department of Urology

jgeck@iu.edu

317-948-9575

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Two separate radiologists (one from Nuclear Medicine and one from MRI) will read images in a blinded fashion and provide their findings for the surgeons to use in treatment planning.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 23, 2021
• Study Start: June 11, 2021
• Primary Completion: July 18, 2022
• Study Completion: July 19, 2022
• Last Updated: August 3, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-08

Locations

US (1)