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PSMA-PET CT Imaging for Prostate Cancer (ESCAPE Trial)
N/A
Recruiting
Led By Timothy Mcclure, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if a non-invasive imaging test can detect prostate cancer that would need treatment in men on active surveillance.
Who is the study for?
Men over 18 with low or favorable intermediate-risk prostate cancer, as defined by NCCN guidelines, can join. They must have a PSA level under 20 ng/ml and be able to undergo yearly PSMA-PET CT scans, prostate biopsies, and mpMRI. Those not interested in active surveillance or with prior treatments for prostate cancer cannot participate.
What is being tested?
The trial is testing the effectiveness of PSMA-PET CT scans in monitoring patients with low to intermediate-risk prostate cancer who are on active surveillance. The goal is to see if this imaging technique can reliably detect the absence of significant cancer progression.
What are the potential side effects?
While the document does not specify side effects related to PSMA-PET CT scans directly, generally such procedures may include discomfort at injection site, allergic reaction to contrast agents used during imaging, and exposure to radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Negative predictive value (NPV)
Secondary study objectives
Number of negative scans on PSMA-PET
Number of negative scans on both PSMA-PET and mpMRI
Number of negative scans on mpMRI
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PSMA-PET CTExperimental Treatment1 Intervention
Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,546 Total Patients Enrolled
49 Trials studying Prostate Cancer
34,458 Patients Enrolled for Prostate Cancer
Timothy Mcclure, M.D.Principal InvestigatorWeill Medical College of Cornell University
Himanshu Nagar, M.D.Principal InvestigatorWeill Medical College of Cornell University
6 Previous Clinical Trials
317 Total Patients Enrolled
3 Trials studying Prostate Cancer
305 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man aged 18 or older.I do not want to wait and watch my condition without treatment.My prostate cancer is confirmed low or favorable intermediate risk without aggressive features.I have received systemic therapy for prostate cancer.I have been treated for prostate cancer before.I can have a yearly prostate MRI.I can have a specialized prostate biopsy.I am willing to have yearly prostate biopsies.I cannot have a transrectal ultrasound.I can have a yearly PSMA-PET CT scan.
Research Study Groups:
This trial has the following groups:- Group 1: PSMA-PET CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.