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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA155301 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dutasteride Year 2 PCa | Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy. |
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| Placebo Year 2 no PCa, Year 4 PCa | Subject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy. |
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| Dutasteride Year 2 no PCa, Year 4 PCa | Subject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy. |
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| Placebo, Year 2 and 4 no PCa | Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy. |
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| Dutasteride, Year 2 and 4 no PCa | Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy. |
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| Placebo, Year 2 PCa | Subject assigned to placebo, prostate cancer found on Year 2 biopsy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutasteride | Drug | 0.5 mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue. | Year 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Multivariable treatment-response score between subjects who develop PCa while on dutasteride and those who do not. | Year 4 | |
| Magnitude of association between nuclear phenotype in benign biopsies, and subsequent risk of PCa in untreated men at elevated risk. |
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Inclusion Criteria:
Exclusion Criteria:
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Probability Sample
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| Name | Affiliation | Role |
|---|---|---|
| Peter H Gann, MD, ScD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | 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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| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial
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| Placebo | Drug | Placebo Comparator |
|
| Year 4 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |