Marker Driven Selection of Patients for Prostate Biopsy and Management (MDSelect)

University of Miami

Status: Enrolling

Conditions: Elevated PSA; Prostate Cancer; PSA

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04240327

U01CA239141-01A1 (U.S. NIH Grant/Contract)

NCI-2020-05157 (Registry Identifier)

20190864

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

GG2+ Prostate Cancer Risk

Description:

Participants at risk for Grade Group 2 (GG2+) prostate cancer. Participants will be followed for up to two years to rule out the presence of GG2+ prostate cancer