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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA239141-01A1 | U.S. NIH Grant/Contract | View source | |
| NCI-2020-05157 | Registry Identifier | NCI Clinical Trials Reporting Program (NCI CTRP) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | 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 and urine biomarkers, versus via standard of care (SoC) MRI interpretation with PIRADS v2. | 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. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| NPV for ruling out GG2+ prostate cancer via HRS MRI Interpretation software versus via SoC MRI interpretation with PIRADS v2 | 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. | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Sanoj Punnen, MD, MAS | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Biopsy Tissue, blood and urine
| NPV for ruling out GG2+ prostate cancer by a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2 | 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. | Up to 24 months |
| 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 | 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 | Up to 24 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |