RECRUITING

Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr

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Conditions

Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr

Quick Facts

Study Start:2024-02-26
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05948657

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.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males aged ≥ 18.
  2. * 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).
  3. * PSA \< 20 ng/ml.
  4. * Ability to undergo yearly PSMA-PET CT.
  5. * Ability to undergo yearly prostate mpMRI.
  6. * Ability to undergo transrectal or transperineal template and fusion prostate biopsy.
  7. * Ability to complete HRQOL surveys (EPIC, IPSS, IIEF-5).
  8. * Willingness to undergo yearly prostate biopsies.
  1. * History of prior treatment for prostate cancer.
  2. * History of systemic therapy for prostate cancer.
  3. * Inability to undergo transrectal ultrasound.
  4. * Life expectancy less than 10 years.
  5. * Not interested in pursuing active surveillance.

Contacts and Locations

Study Contact

Pragya Yadav, Ph.D.
CONTACT
646-962-2199
pry2003@med.cornell.edu
Sharanya Chandrasekhar, M.S.
CONTACT
646-962-3110
shc2043@med.cornell.edu

Principal Investigator

Timothy Mcclure, M.D.
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Himanshu Nagar, M.D.
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

UCLA
Los Angeles, California, 90005
United States
UCSF
San Francisco, California, 94143
United States
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, 10065
United States
Case Western University Hospitals
Cleveland, Ohio, 44106
United States
UT Southwestern
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Timothy Mcclure, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University
  • Himanshu Nagar, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

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 Registration Dates

Study Start Date2024-02-26
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-02-26
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Cancer