Using PSMA-PET imaging to improve prostate cancer surgery outcomes

PSMA-PET to Guide Prostatectomy: A Randomized Trial

This study is testing if adding a special PSMA PET scan to the usual MRI can help improve surgery results for men with prostate cancer.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 288 (estimated)
• Ages: 40 Years to 80 Years
• Sex: Male
• Sponsor: Five Eleven Pharma, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT05381103 on ClinicalTrials.gov

What this trial studies

This study involves 196 patients who will be randomly assigned to receive either the standard of care MRI or both the standard MRI and a PSMA PET scan prior to prostate surgery. The findings from the PET and MRI scans will be compared against whole mount pathology to validate their effectiveness. Additionally, the study will assess how these imaging results influence surgical plans and patient outcomes. The goal is to determine if incorporating PSMA PET imaging can enhance the surgical approach for prostate cancer patients.

Who should consider this trial

Good fit: Ideal candidates are men with significant prostate cancer who wish to maintain erectile function and are scheduled for prostatectomy.

Not a fit: Patients with advanced prostate cancer or those who do not desire to maintain erectile function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and better management of prostate cancer.

How similar studies have performed: Other studies have shown promising results with similar imaging approaches, indicating potential for success in this novel application.

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.

Where this trial is running

Indianapolis, Indiana

• Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)

Study contacts

• Principal investigator: Clinton Bahler, MD — Indiana University
• Study coordinator: Jennifer Lehman

Conditions Prostate Cancer