Clinical trial NCT04240327: Marker Driven Selection of Patients for Prostate Biopsy and Management
Official title: Marker Driven Selection of Patients for Prostate Biopsy and Management: The University of Miami MDSelect Protocol
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: PSA
Elevated PSA
Prostate Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-01-27
Enrollment: 289
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be targeted for enrollment from a consecutive cohort of men who are referred to the University of Miami for prostate cancer evaluation and management, which includes internal and external physician referrals, most often due to an increased PSA, and/or abnormal digital rectal exam (DRE).

Brief 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 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Negative Predictive Value (NPV) for ruling out GG2+ prostate cancer via Habitat Risk Score (HRS) MRI Interpretation software combined with a panel of blood and urine biomarkers, versus via standard of care (SoC) MRI interpretation with PIRADS v2.
timeFrame: Up to 24 months
Secondary outcomes:
measure: NPV for ruling out GG2+ prostate cancer via HRS MRI Interpretation software versus via SoC MRI interpretation with PIRADS v2
timeFrame: Up to 24 months
measure: NPV for ruling out GG2+ prostate cancer by a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2
timeFrame: Up to 24 months
measure: NPV for ruling out clinically significant prostate cancer via HRS MRI interpretation software combined with a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sanoj Punnen, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: