What this study is
This study will be assessing the ability of PSMA-PET CT to determine the absence of clinically significant prostate cancer in patients on active surveillance (AS) with low risk and favorable intermediate-risk prostate cancer.
What's being tested
- PSMA-PET CT
Intervention · DIAGNOSTIC TEST
Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
Study details
- Official title
- ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
- Sponsor
- Weill Medical College of Cornell University
- Conditions
- Prostate Cancer
- Enrolling
- 200 people
- Starts
- 2024-02-26
- Est. completion
- 2028-12
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- Males aged ≥ 18.
- Histologically confirmed low or favorable intermediate risk prostate cancer per NCCN guidelines. (Note: Grade Group 2 must have 20% or less involvement in every core and no presence of cribiform or intraductal carcinoma).
- PSA < 20 ng/ml.
- Ability to undergo yearly PSMA-PET CT.
- Ability to undergo yearly prostate mpMRI.
- Ability to undergo transrectal or transperineal template and fusion prostate biopsy.
- Willingness to undergo yearly prostate biopsies.
You can't join if
- History of prior treatment for prostate cancer.
- History of systemic therapy for prostate cancer.
- Inability to undergo transrectal ultrasound.
- Life expectancy less than 10 years.
- Not interested in pursuing active surveillance.
- Initial diagnosis of prostate cancer greater than 15 months.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openUCLA
Los Angeles, California, United States
- Sarah Yuan · Contactsay7008@med.cornell.edu
- Wayne Brisbane, M.D. · Principal investigator
Not yet recruitingUCSF
San Francisco, California, United States
- Sarah Yuan · Contactsay7008@med.cornell.edu
- Matthew Cooperberg, M.D. · Principal investigator
Not yet recruitingWeill Cornell Medicine - New York Presbyterian Hospital
New York, New York, United States
- Timothy McClure, M.D. · Contacttim9047@med.cornell.edu
- Timothy McClure, M.D. · Principal investigator
RecruitingUH Cleveland Medical Center
Cleveland, Ohio, United States
- Matt Ferrebee · ContactMatthew.Ferrebee@UHhospitals.org
- Jonathan Shoag, M.D. · Principal investigator
Recruiting
Study team
Sponsor
Weill Medical College of Cornell University
Study ID 23-03025893
Principal investigator
Timothy McClure, M.D.
Weill Medical College of Cornell University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.