RECRUITING

EDRN Prostate MRI Biomarker Study

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

The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy setting given the availability of validated prostate cancer early detection markers is uncertain.This study will allow investigators to determine if prostate MRI is superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial biopsy setting.

Official Title

EDRN Prostate MRI Biomarker Study and Reference Set

Quick Facts

Study Start:2019-02-04
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03784924

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
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men with suspected but undiagnosed prostate cancer
  2. * To be scheduled/scheduled for biopsy as routine clinical care
  1. * Inability to obtain blood and urine per SOP or conduct an attentive DRE
  2. * Unable to undergo/tolerate a prostate MRI or failure to conduct the MRI
  3. * Prior diagnosis of prostate cancer
  4. * Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one year prior to consent date)
  5. * Participating in clinical trial for prostate disease
  6. * Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift
  7. * Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose

Contacts and Locations

Study Contact

Jackie Dahlgren
CONTACT
206-667-3438
jdahlgre@fredhutch.org

Principal Investigator

John T Wei, MD, MS
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • John T Wei, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

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 Date2019-02-04
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2019-02-04
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Prostate cancer
  • psa
  • early detection
  • MRI

Additional Relevant MeSH Terms

  • PSA
  • Prostate Cancer