PSMA-PET to Guide Prostatectomy
C
Clinton Bahler, MD
Primary Investigator
Enrolling By Invitation
40-80 years
Male
Phase
2/3
288 participants needed
3 Locations
Overview
In this study, 288 patients will be randomized 1:1 to either having only the standard of careRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (andRI) 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 impactingual patient outcomes.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Prostate Cancer
-
Age: Between 40 Years - 80 Years
-
Gender: Male
Inclusion Criteria:
- Men diagnosed with prostate cancer who choose radical prostatectomy
- Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% OR ≥3 cores ofGleason 3+4 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 erectiledysfunction OR mild-to-moderate erectile dysfunction (International Index of ErectileFunction-Erectile Function domain ≥ 17). AND
- The patient desires to maintain erections following treatment.
Exclusion Criteria:
- Participation in another investigational trial involving research exposure to ionizingdiation concurrently or within 30 days
- Patient is unable to tolerate remaining still on the bed of the PET or MRI camera, duehysical limitations or claustrophobia.
- c. Significant acute or chronic medical condition in the subject that could compromisehe objectives of the study.
Updated on
15 May 2024.
Study ID: IU_CLN02_EPE
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