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 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:
- 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.