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Marker Driven Selection of Patients for Prostate Biopsy and Management

Marker Driven Selection of Patients for Prostate Biopsy and Management

Non Recruiting
40-85 years
Male
Phase N/A

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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).

Eligibility

Inclusion 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.

Exclusion Criteria:

  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.

Study details
    PSA
    Elevated PSA
    Prostate Cancer

NCT04240327

University of Miami

20 August 2025

FAQs

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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