ACTIVE_NOT_RECRUITING

Marker Driven Selection of Patients for Prostate Biopsy and Management

Talk to us

Conditions

PSAElevated PSAProstate Cancer

Quick Navigation

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 purpose of this research study is to determine if the interpretation of multiparametric MRI (mpMRI) with an algorithm called habitat risk score (HRS) in combination with a panel of blood and urine biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpMRI with the Prostate Imaging Reporting and Data System (PIRADS).

Official Title

Marker Driven Selection of Patients for Prostate Biopsy and Management: The University of Miami MDSelect Protocol

Quick Facts

Study Start:2020-06-29
Study Completion:2027-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04240327

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:40 Years to 85 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male participant, aged 40-85 years.
  2. 2. In good general health as evidenced by medical history.
  3. 3. Referred for a biopsy of the prostate for evaluation of prostate cancer due to elevated or increasing prostate-specific antigen (PSA) or an abnormal digital rectal exam (DRE).
  4. 4. Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers.
  1. 1. Previous or current history of prostate cancer or treatment for prostate cancer.
  2. 2. Previous history of pelvic radiation.
  3. 3. Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity.
  4. 4. Inability to undergo blood draw or biopsy of the prostate as per protocol.
  5. 5. Prior MRI guided biopsy of the prostate for prostate cancer evaluation.
  6. 6. Previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial.
  7. 7. Standard contraindications to MRI, such as allergies to contrast die, renal toxicity, ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted) will prevent eligibility and will be applied for all protocol-related MRIs.
  8. 8. Patients with impaired decision-making capacity.

Contacts and Locations

Principal Investigator

Sanoj Punnen, MD, MAS
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Sanoj Punnen, MD, MAS, PRINCIPAL_INVESTIGATOR, University of Miami

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 Date2020-06-29
Study Completion Date2027-06-01

Study Record Updates

Study Start Date2020-06-29
Study Completion Date2027-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • PSA
  • Elevated PSA
  • Prostate Cancer