Marker Driven Selection of Patients for Prostate Biopsy and Management, University of Miami MDSelect Study

PRIMARY OBJECTIVE:

I. To assess whether an automated quantitative HRS MRI interpretation software combined with a panel of blood and urine biomarkers can incrementally improve the negative predictive value for ruling out (grade group 2 or higher) GG2+ cancer on prostate biopsy by 30% or more above standard of care MRI interpretation with PIRADSv2.

SECONDARY OBJECTIVES:

I. To assess whether an automated quantitative HRS MRI interpretation software can incrementally improve the negative predictive value for ruling out GG2+ cancer on prostate biopsy by 20% or more above standard of care MRI interpretation with PIRADSv2.

II. To assess whether a panel of blood and urine biomarkers can incrementally improve the negative predictive value for ruling out GG2+ cancer on prostate biopsy by 10% or more above standard of care MRI interpretation with PIRADSv2.

III. To assess whether automated quantitative HRS MRI interpretation software combined with a panel of blood 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 grade group 1 [GG1] cancer) on prostate biopsy by 30% or more above standard of care MRI interpretation with PIRADSv2.

EXPLORATORY OBJECTIVES:

I. To assess whether an automated quantitative HRS MRI interpretation software combined with a panel of blood and urine biomarkers can incrementally improve the negative predictive value for ruling out GG2+ OR intermediate/genomic risk cancer on prostate biopsy by 30% or more above standard of care MRI interpretation with PIRADSv2.

II. To evaluate various biopsy strategies (template alone, template + PIRADS targets, HRS + PIRADSv2 targets alone, or template + HRS targets + PIRADS targets) to evaluate differences in biopsies avoided, core biopsies required and GG2+ cancers detected and missed.

III. To evaluate associations between serial biomarker scores and the detection of GG2+ cancer on the second biopsy in men who were found to have either indolent cancer or no cancer on the first biopsy in the trial.

OUTLINE:

Participants undergo mpMRI with standard of care PIRADSv2 and HRS interpretation, and then undergo standard of care biopsy of prostate and collection of tissue samples at baseline and at 6-24 months. Patients also undergo collection of blood and urine samples at baseline and at 6, 12, 18, and 24 months after initial biopsy.

After completion of study, participants may be followed up periodically.