- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05381103
PSMA-PET to Guide Prostatectomy
February 14, 2024 updated by: Five Eleven Pharma, Inc.
PSMA-PET to Guide Prostatectomy: A Randomized Trial
In this study, 288 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
288
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Lehman
- Phone Number: 317-274-1791
- Email: jgeck@iu.edu
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
-
Contact:
- Mark Green, Ph.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 of Gleason 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 erectile dysfunction OR mild-to-moderate erectile dysfunction (International Index of Erectile Function-Erectile Function domain ≥ 17). AND
- The patient desires to maintain erections following treatment.
Exclusion Criteria:
- Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days
- Patient is unable to tolerate remaining still on the bed of the PET or MRI camera, due to physical limitations or claustrophobia.
- c. Significant acute or chronic medical condition in the subject that could compromise the objectives of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PSMA-PET and SOC MRI prior to surgery
|
60 min continuous acquisition of PET data after 3-6 mCI injection of [68Ga]P16-093 followed by contrast-CT
|
Active Comparator: SOC MRI prior to surgery
|
Standard of care MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IIEF-EF sub scale score
Time Frame: 1 month
|
International Index Erectile Function-Erectile Function sub scale score.
Maximum score is 30 with higher score indicating better outcomes.
|
1 month
|
IIEF-EF sub scale score
Time Frame: 3 months
|
International Index Erectile Function-Erectile Function sub scale score.
Maximum score is 30 with higher score indicating better outcomes.
|
3 months
|
IIEF-EF sub scale score
Time Frame: 6 months
|
International Index Erectile Function-Erectile Function sub scale score.
Maximum score is 30 with higher score indicating better outcomes.
|
6 months
|
IIEF-EF sub scale score
Time Frame: 12 months
|
International Index Erectile Function-Erectile Function sub scale score.
Maximum score is 30 with higher score indicating better outcomes.
|
12 months
|
IIEF-EF sub scale score
Time Frame: 18 months
|
International Index Erectile Function-Erectile Function sub scale score.
Maximum score is 30 with higher score indicating better outcomes.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in treatment plan
Time Frame: 1 month
|
Proportion of patients whose treatment plan would be changed by PSMA-PET.
Treatment changes are defined as any change in surgical resection plan that affects one of 4 critical regions for quality of life
|
1 month
|
Ratio of positive surgical margins to nerve bundles spared
Time Frame: 1 month
|
1 month
|
|
EPE detection
Time Frame: 1 month
|
Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles
|
1 month
|
Incontinence bother
Time Frame: 18 months
|
Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2
|
18 months
|
Incontinence: using 0-1 pads per day
Time Frame: 18 months
|
Expanded Prostate Cancer Index Composite (EPIC-26) question 3
|
18 months
|
Urgency/frequency
Time Frame: 18 months
|
Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5
|
18 months
|
Erectile dysfunction: ability to achieve erection sufficient for penetration
Time Frame: 18 months
|
IIEF question 3
|
18 months
|
Overall mental and physical health
Time Frame: 18 months
|
Short Form quality of life questionnaire (SF-36)
|
18 months
|
Surgical margins
Time Frame: 1 month
|
postive surgical margin rates
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Clinton Bahler, MD, Indiana University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
March 31, 2028
Study Registration Dates
First Submitted
April 29, 2022
First Submitted That Met QC Criteria
May 15, 2022
First Posted (Actual)
May 19, 2022
Study Record Updates
Last Update Posted (Estimated)
February 15, 2024
Last Update Submitted That Met QC Criteria
February 14, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IU_CLN02_EPE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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