Marker Driven Selection of Patients for Prostate Biopsy and Management

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    300
  • sponsor
    University of Miami
Updated on 19 February 2024
testosterone
prostate specific antigen
tumor markers
digital rectal examination
digital rectal exam
biopsy of prostate
multiparametric magnetic resonance imaging

Summary

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 biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpMRI with the Prostate Imaging Reporting and Data System (PIRADS).

Details
Condition Malignant neoplasm of prostate, PROSTATE SPECIFIC ANTIGEN, Prostatic disorder, Elevated PSA
Age 40-85 years
Clinical Study IdentifierNCT04240327
SponsorUniversity of Miami
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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