NCT04240327Active, not recruiting
Marker Driven Selection of Patients for Prostate Biopsy and Management
Marker Driven Selection of Patients for Prostate Biopsy and Management: The University of Miami MDSelect Protocol
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 289 (actual)
- First submitted
- 20 Jan 2020
- Start date
- 29 Jun 2020
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- University of Miami
- Diseases
- Prostate cancer
- NCT number
- NCT04240327
What you commit to
- Study type: Observational
- Participants enrolled: 289
- From 29 Jun 2020 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current history of prostate cancer or treatment for prostate cancer.
- Previous history of pelvic radiation.
- 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.
Other illness
- Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity.
- 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.
Other
- Inability to undergo blood draw or biopsy of the prostate as per protocol.
- Patients with impaired decision-making capacity.
Who the study is looking for
- 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.
Age in the registry: 40 years to 85 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.