PSMA-PET to Guide Prostatectomy

NCT05381103 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IU_CLN02_EPE
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Change in treatment plan

  1 month

• Ratio of positive surgical margins to nerve bundles spared

  1 month

• EPE detection

  1 month

• Incontinence bother

  18 months

• Incontinence: using 0-1 pads per day

  18 months

Study Arms (2)

PSMA-PET and SOC MRI prior to surgery

EXPERIMENTAL

Diagnostic Test: PSMA-PET and SOC MRI

SOC MRI prior to surgery

ACTIVE COMPARATOR

Diagnostic Test: SOC MRI

Interventions

PSMA-PET and SOC MRI DIAGNOSTIC_TEST

60 min continuous acquisition of PET data after 3-6 mCI injection of \[68Ga\]P16-093 followed by contrast-CT

PSMA-PET and SOC MRI prior to surgery

SOC MRI DIAGNOSTIC_TEST

Standard of care MRI

SOC MRI prior to surgery

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Baseline sexual function (IIEF-EF \> 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
• The patient desires to maintain erections following treatment
• 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.
• Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.

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 is not allowed, since MRI is required for comparison).
• 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

• Five Eleven Pharma, Inc.: lead
• Indiana University: collaborator

Study Sites (1)

Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

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

Study Officials

• Clinton Bahler, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Lehman

CONTACT

317-274-1791; jgeck@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 19, 2022
• Study Start: October 1, 2021
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 31, 2025

Record last verified: 2024-10

Locations

US (1)