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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240327
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 15, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sanoj Punnen, MD, MAS, University of Miami

Study Description
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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).

Condition or disease
PSA Elevated PSA Prostate Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Marker Driven Selection of Patients for Prostate Biopsy and Management: The University of Miami MDSelect Protocol
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
GG2+ Prostate Cancer Risk
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


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: Up to 24 months ]
    The investigators will assess whether automated quantitative HRS MRI interpretation software combined with a panel of blood and urine biomarkers incrementally improves the negative predictive value for ruling out GG2+ cancer on prostate biopsy by 30% or more above standard of care (SoC) MRI interpretation with PIRADS v2.


Secondary Outcome Measures :
  1. NPV for ruling out GG2+ prostate cancer via HRS MRI Interpretation software versus via SoC MRI interpretation with PIRADS v2 [ Time Frame: Up to 24 months ]
    The investigators will assess whether automated quantitative HRS MRI interpretation software can incrementally improve the negative predictive value (NPV) for ruling out GG2+ cancer on prostate biopsy by 20% or more above SoC MRI interpretation with PIRADS v2.

  2. NPV for ruling out GG2+ prostate cancer by a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2 [ Time Frame: Up to 24 months ]
    The investigators will assess whether a panel of blood and urine biomarkers can incrementally improve the negative predictive value (NPV) for ruling out GG2+ cancer on prostate biopsy by 10% or more above SoC MRI interpretation with PIRADS v2.

  3. 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 [ Time Frame: Up to 24 months ]
    The investigators will assess whether automated quantitative HRS MRI interpretation software combined with a panel of blood and urine 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 GG1 cancer) on prostate biopsy by 30% or more above standard of care MRI interpretation with PIRADS v2


Biospecimen Retention:   Samples With DNA
Biopsy Tissue, blood and urine

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240327


Contacts
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Contact: Elena M Cortizas, MS 305-243-6438 ecortizas@med.miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Elena M Cortizas, MS    305-243-6438    ecortizas@med.miami.edu   
Principal Investigator: Sanoj Punnen, MD, MAS         
Sponsors and Collaborators
University of Miami
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sanoj Punnen, MD, MAS University of Miami
More Information
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Responsible Party: Sanoj Punnen, MD, MAS, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04240327    
Other Study ID Numbers: 20190864
U01CA239141-01A1 ( U.S. NIH Grant/Contract )
NCI-2020-05157 ( Registry Identifier: NCI Clinical Trials Reporting Program (NCI CTRP) )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases