Back to resultsThe Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68Ga-PSMA-11 PET Scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. 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 3. 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:
1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
2. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).
3. 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.
Sites / Locations
- Indiana University Health University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy
Arm Description
1. 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
Outcomes
Primary Outcome Measures
Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension
Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles
Specificity of PSMA-PET and MRI
Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.
Secondary Outcome Measures
1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET
Rate of treatment changes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04936334
Brief Title
The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer
Official Title
The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
July 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Clinton Bahler
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.
Masking
None (Open Label)
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.
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy
Arm Type
Experimental
Arm Description
1. 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 Type
Diagnostic Test
Intervention Name(s)
68Ga-PSMA-11 PET Scan
Intervention Description
Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.
Primary Outcome Measure Information:
Title
Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension
Description
Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles
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.
Title
Specificity of PSMA-PET and MRI
Description
Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.
Time Frame
Pre-surgery prediction.
Secondary Outcome Measure Information:
Title
1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET
Description
Rate of treatment changes
Time Frame
60 Days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. 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 3. 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:
1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
2. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).
3. 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.
Facility Information:
Facility Name
Indiana University Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer
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