PSMA-PET to Guide Prostatectomy
C
Clinton Bahler, MD
Primary Investigator
Enrolling By Invitation
40-80 years
Male
Phase
2/3
288 participants needed
4 Locations
Brief description of study
What is the purpose of this study?
This study will randomize subjects to either standard of care MRI prior to radical prostatectomy or standard of care MRI and the PSMA (prostate specific membrane antigen) PET scan prior to radical prostatectomy to see if this scan will be helpful in detecting prostate cancer and guiding surgical treatment. A goal for this cohort is to measure the frequency of treatment modifications that post preserve nerve tissue and minimize positive margins based on PSMA PET review, and measure if there is improved patient reported quality of life in the group with the PSMA-PET surgical planning when compared to standard of care measures.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- 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 of study
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
01 Aug 2024.
Study ID: IU_CLN02_EPE, IUSCCC-0790, 13892
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