PSMA-PET to Guide Prostatectomy

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

PSMA-PET to Guide Prostatectomy: A Randomized Trial

PSMA-PET to Guide Prostatectomy

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Significant prostate cancer:
  • 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.
  • 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.

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Five Eleven Pharma, Inc.,

Clinton Bahler, MD, PRINCIPAL_INVESTIGATOR, Indiana University School of Medicine

Study Record Dates

2028-12-01