Prostate Cancer Clinical Trial
PSMA-PET to Guide Prostatectomy
Summary
In this study, 288 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.
Eligibility Criteria
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 of Gleason 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 erectile dysfunction OR mild-to-moderate erectile dysfunction (International Index of Erectile Function-Erectile Function domain ≥ 17). AND
The patient desires to maintain erections following treatment.
Exclusion Criteria:
Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days
Patient is unable to tolerate remaining still on the bed of the PET or MRI camera, due to physical limitations or claustrophobia.
c. Significant acute or chronic medical condition in the subject that could compromise the objectives of the study.
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There is 1 Location for this study
Indianapolis Indiana, 46202, United States More Info
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