The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Specificity of PSMA-PET and MRI
Study Overview
Brief Summary
Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard).
Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).
Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.
Assess quality of life changes from preoperative baseline.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
Two separate radiologists (one from Nuclear Medicine and one from MRI) will read images in a blinded fashion and provide their findings for the surgeons to use in treatment planning.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy
- •Prostate pathology results consistent with:
- •> 3 cores of Gleason 3+4 or
- •NCCN unfavorable intermediate risk or
- •NCCN high-risk or
- •NCCN very-high risk
- •Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months).
- •Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI
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 could affect prostate imaging).
- •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.
Arms & Interventions
Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy
- Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery
Intervention: 68Ga-PSMA-11 PET Scan (Diagnostic Test)
Outcomes
Primary Outcomes
Specificity of PSMA-PET and MRI
Time Frame: Pre-surgery prediction.
Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.
Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension
Time Frame: The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.
Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles
Secondary Outcomes
- 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET(60 Days)
Investigators
Clinton Bahler
Principal Investigator
Indiana University