PSMA-PET to Guide Prostatectomy: A Sub-study
Clinton Bahler, MD
Primary Investigator
Brief description of study
What is the purpose of this 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
What will happen during the study?
- Phase II, single blind, single arm trial with longitudinal outcome.
- 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: Cancer
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Age: 18 years - 100 years
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Gender: Male
Men diagnosed with prostate cancer who choose radical prostatectomy and meet the following criteria:
1) Inclusion criteria: Patient must meet all inclusion criteria (a-f)
a. Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% OR Gleason 3+4 ≥1 core with ≥50% overall 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.
b. 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).
c. The patient desires to maintain erections following treatment.
d. 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.
e. Prostatectomy candidate per treating uro-oncologist with prostatectomy planned within 90 days of consent.
f. Patient REQUIRES PSMA-PET as part of standard of care in the judgement of the treating surgeon OR patient already has a PSMA-PET as part of standard-of-care
2) Exclusion Criteria:
a. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
b. Does not meet safety criteria for MRI and/or PET scan (e.g. metal implant that is not allowed, severe claustrophobia, unable to lie flat, etc.).
c. 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.
