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Active, Not Recruiting

NCT Number: NCT04240327

Marker Driven Selection of Patients for Prostate Biopsy and Management

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

PsA Elevated PSA Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male participant, aged 40-85 years.
  • In good general health as evidenced by medical history.
  • 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).
  • Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers.

Exclusion criteria

  • Previous or current history of prostate cancer or treatment for prostate cancer.
  • Previous history of pelvic radiation.
  • Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity.
  • Inability to undergo blood draw or biopsy of the prostate as per protocol.
  • Prior MRI guided biopsy of the prostate for prostate cancer evaluation.
  • Previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial.
  • 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.
  • Patients with impaired decision-making capacity.

Treatment and study plan

Primary outcomes

  1. Negative Predictive Value (NPV) for ruling out GG2+ prostate cancer via Habitat Risk Score (HRS) MRI Interpretation software combined with a panel of blood and urine biomarkers, versus via standard of care (SoC) MRI interpretation with PIRADS v2.

    Time frame: Up to 24 months

    The investigators will assess whether automated quantitative HRS MRI interpretation software combined with a panel of blood and urine biomarkers incrementally improves the negative predictive value for ruling out GG2+ cancer on prostate biopsy by 30% or more above standard of care (SoC) MRI interpretation with PIRADS v2.

Secondary outcomes

  1. NPV for ruling out GG2+ prostate cancer via HRS MRI Interpretation software versus via SoC MRI interpretation with PIRADS v2

    Time frame: Up to 24 months

    The investigators will assess whether automated quantitative HRS MRI interpretation software can incrementally improve the negative predictive value (NPV) for ruling out GG2+ cancer on prostate biopsy by 20% or more above SoC MRI interpretation with PIRADS v2.

  2. NPV for ruling out GG2+ prostate cancer by a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2

    Time frame: Up to 24 months

    The investigators will assess whether a panel of blood and urine biomarkers can incrementally improve the negative predictive value (NPV) for ruling out GG2+ cancer on prostate biopsy by 10% or more above SoC MRI interpretation with PIRADS v2.

  3. NPV for ruling out clinically significant prostate cancer via HRS MRI interpretation software combined with a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2

    Time frame: Up to 24 months

    The investigators will assess whether automated quantitative HRS MRI interpretation software combined with a panel of blood and urine biomarkers incrementally improves the negative predictive value for ruling out clinically significant prostate cancer (defined as any GG2+ cancer OR 50% or more cores of GG1 cancer) on prostate biopsy by 30% or more above standard of care MRI interpretation with PIRADS v2

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: MDSelect

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2020
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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