Marker Driven Selection of Patients for Prostate Biopsy and Management: The University of Miami MDSelect Protocol

Marker Driven Selection of Patients for Prostate Biopsy and Management

Sponsors

Lead sponsor: University of Miami

Collaborator: National Cancer Institute (NCI)

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

Overall Status Not yet recruiting
Start Date June 2020
Completion Date June 2025
Primary Completion Date June 2025
Study Type Observational
Primary Outcome
Measure Time Frame
Negative Predictive Value (NPV) for ruling out GG2+ prostate cancer via Habitat Risk Score (HRS) MRI Interpretation software combined with a panel of blood biomarkers, versus via standard of care (SoC) MRI interpretation with PIRADS v2. Up to 24 months
Secondary Outcome
Measure Time Frame
NPV for ruling out GG2+ prostate cancer via HRS MRI Interpretation software versus via SoC MRI interpretation with PIRADS v2 Up to 24 months
NPV for ruling out GG2+ prostate cancer by a panel of blood biomarkers versus via SoC MRI interpretation with PIRADS v2 Up to 24 months
NPV for ruling out clinically significant prostate cancer via HRS MRI interpretation software combined with a panel of blood biomarkers versus via SoC MRI interpretation with PIRADS v2 Up to 24 months
Enrollment 300
Condition
Eligibility

Sampling method: Non-Probability Sample

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.

Gender: Male

Minimum age: 40 Years

Maximum age: 85 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Sanoj Punnen, MD, MAS Principal Investigator University of Miami
Overall Contact

Last name: Sanoj Punnen, MD, MAS

Phone: 305-243-3246

Email: [email protected]

Location
facility contact investigator University of Miami Sanoj Punnen, MD, MAS 305-243-3246 [email protected] Sanoj Punnen, MD, MAS Principal Investigator
Location Countries

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Miami

Investigator full name: Sanoj Punnen, MD, MAS

Investigator title: Associate Professor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: 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

Acronym MDSelect
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov