PSMA-PET to Guide Prostatectomy

PSMA-PET to Guide Prostatectomy: A Randomized Trial

In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: PSMA-PET and SOC MRI; Diagnostic test: SOC MRI

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jennifer Lehman; Phone Number: 317-274-1791; Email: jgeck@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
      • Contact: Mark Green, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Significant prostate cancer:

   Gleason 3+4 ≥1 core with pattern 4 ≥20%

   Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR

   NCCN unfavorable intermediate risk OR

   Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND

2. Baseline sexual function (IIEF-EF > 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
3. The patient desires to maintain erections following treatment
4. Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant.
5. Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.

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 is not allowed, since MRI is required for comparison).
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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PSMA-PET and SOC MRI prior to surgery	Diagnostic test: PSMA-PET and SOC MRI; 60 min continuous acquisition of PET data after 3-6 mCI injection of [68Ga]P16-093 followed by contrast-CT
Active Comparator: SOC MRI prior to surgery	Diagnostic test: SOC MRI; Standard of care MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IIEF-EF sub scale score	International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.	1 month
IIEF-EF sub scale score	International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.	3 months
IIEF-EF sub scale score	International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.	6 months
IIEF-EF sub scale score	International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.	12 months
IIEF-EF sub scale score	International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in treatment plan	Proportion of patients whose treatment plan would be changed by PSMA-PET. Treatment changes are defined as any change in surgical resection plan that affects one of 4 critical regions for quality of life	1 month
Ratio of positive surgical margins to nerve bundles spared		1 month
EPE detection	Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles	1 month
Incontinence bother	Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2	18 months
Incontinence: using 0-1 pads per day	Expanded Prostate Cancer Index Composite (EPIC-26) question 3	18 months
Urgency/frequency	Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5	18 months
Erectile dysfunction: ability to achieve erection sufficient for penetration	IIEF question 3	18 months
Overall mental and physical health	Short Form quality of life questionnaire (SF-36)	18 months
Surgical margins	postive surgical margin rates	1 month

Collaborators and Investigators

• Sponsor: Five Eleven Pharma, Inc.
• Collaborators: Indiana University
• Investigators: Principal Investigator: Clinton Bahler, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 15, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IU_CLN02_EPE

Drug and device information, study documents

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