PSMA-PET to Guide Prostatectomy: A Sub-study
Study on Imaging Techniques for Prostate Cancer Surgery
Clinton Bahler, MD
Primary Investigator
Brief description of study
This sub-study consists of a single treatment group of men that require a PET scan to guide their radical prostatectomy, every subject will receive an MRI and the PSMA (prostate specific membrane antigen) PET scan prior to their surgery to determine if the PSMA PET scan is helpful in detecting prostate cancer at the edge of the prostate and guiding surgical treatment. The main outcome of this study is to review the sensitivity/specificity for extra-prostatic extension at the nerve bundles. A secondary goal for this cohort is to measure the proportion of patients whose treatment plan would be changed by PSMA-PET measured through changes in resection plans that affect one of 4 critical regions for quality of life.
Detailed description of study
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.
- This is a Sub-study of “PSMA-PET to Guide Prostatectomy: A Randomized Trial” (IRB# 13892, NCT #05381103).
- This allows men requiring PSMA-PET scan as standard of care due to concern for metastasis (cannot be randomized in an ethical manner in the opinion of the treating surgeon) to enroll.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Prostate Cancer
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Age: 18 years - 100 years
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Gender: Male
Inclusion Criteria:
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
- Baseline sexual function (IIEF-EF > 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
- The patient desires to maintain erections following treatment
- 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.
- Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.
Exclusion Criteria:
- Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).
- 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.
This study investigates the use of a special scan called PSMA PET to guide surgery for prostate cancer. The purpose is to find out if the PSMA PET scan can better detect cancer near the edge of the prostate and help doctors plan the surgery. Prostate cancer is a disease where cells in the prostate grow out of control. In this study, some patients will have both an MRI and a PSMA PET scan before their surgery, while others will only have the MRI. The study will compare these imaging tests to see which one is better at showing where the cancer is located.
Participants in the study will undergo imaging tests before their surgery. The main test being studied is the PSMA PET scan, which is compared with the MRI scan. The results of these scans will be checked against the actual findings during surgery to see how accurate they are. The study will also look at whether the scan results change the surgical plan for the patient.
- Who can participate: Men with certain types of prostate cancer and specific Gleason scores who plan to have surgery to remove the prostate within 90 days can join. They must also have baseline sexual function and either have had or plan to have an MRI.
- Study details: Participants will receive an MRI and a PSMA PET scan before surgery. The study will compare the results of these scans to see if they assist in planning the surgery better. The PSMA PET scan is a special test to find cancer cells.
