PSMA-PET to Guide Prostatectomy

NCT ID: NCT05381103

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2028-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

PSMA-PET and SOC MRI prior to surgery

Group Type: EXPERIMENTAL

PSMA-PET and SOC MRI

Intervention Type: DIAGNOSTIC_TEST

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

SOC MRI prior to surgery

Group Type: ACTIVE_COMPARATOR

SOC MRI

Intervention Type: DIAGNOSTIC_TEST

Standard of care MRI

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

SOC MRI

Standard of care MRI

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: collaborator

Five Eleven Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinton Bahler, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Lehman

Role: CONTACT

jgeck@iu.edu

317-274-1791

Facility Contacts

Mark Green, Ph.D

Role: primary

Other Identifiers

IU_CLN02_EPE

Identifier Type: -

Identifier Source: org_study_id