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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04602 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 8760 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| RG1004195 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P50CA097186 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Canary Foundation | OTHER |
| CureBRCA | UNKNOWN |
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This study investigates ways to detect prostate cancer earlier in people at genetic risk for disease that forms, grows, or spreads quickly (aggressive). Studying samples of blood, urine, and/or tissue in the laboratory may help doctors further understand the genetics of prostate cancer and help identify ways to detect cancer earlier, thereby improving treatment and methods of early detection in the future.
OUTLINE:
Participants undergo collection of blood, urine, and/or tissue samples every 6-12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 3-9 months after completion of curative therapy for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (biospecimen collection) | Participants undergo collection of blood, urine, and/or tissue samples every 12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 12 months after completion of curative therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood, urine, and/or tissue samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds | To estimate PPVs of age-based PSA thresholds for biopsy referral in this patient population, will first fit a logistic regression model to estimate the odds that biopsy leads to a prostate cancer diagnosis. The regression will have a binary indicator of prostate cancer diagnosis as the response variable, patient age at biopsy (categorized as < 50, 50-59, or >= 60 years to correspond to the age-based PSA thresholds) as a fixed effect, and a unique patient identifier as a random effect to account for possibly repeated biopsies. Will then convert the estimated odds that biopsy leads to a prostate cancer diagnosis within each age category into corresponding probabilities of this outcome-i.e., PPV point estimates and associated 95% confidence intervals-using the inverse logit function. | Up to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
People with prostates
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Germline carriers of pathogenic or likely pathogenic mutations in genes associated with increased risk of prostate cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Team Coordinator | Contact | 206-210-4040 | patrol@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heather H. Cheng, MD, PhD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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Blood, urine, tissue
| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| Northwestern | Recruiting | Chicago | Illinois | 60611 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
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| University of Pennsylvania/Abramson Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Texas Health Science Center at San Antonio | Terminated | San Antonio | Texas | 78229 | United States |
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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