Marker Driven Selection of Patients for Prostate Biopsy and Management

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).

Conditions

PSA, Elevated PSA, Prostate Cancer

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Study Overview

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Study Details

Study overview

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).

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

Marker Driven Selection of Patients for Prostate Biopsy and Management

Condition
PSA
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male participant, aged 40-85 years.
  • 2. In good general health as evidenced by medical history.
  • 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. Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers.
  • 1. Previous or current history of prostate cancer or treatment for prostate cancer.
  • 2. Previous history of pelvic radiation.
  • 3. Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity.
  • 4. Inability to undergo blood draw or biopsy of the prostate as per protocol.
  • 5. Prior MRI guided biopsy of the prostate for prostate cancer evaluation.
  • 6. Previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial.
  • 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. Patients with impaired decision-making capacity.

Ages Eligible for Study

40 Years to 85 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Miami,

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

Study Record Dates

2025-06-01