Prostate Screening for Men With Inherited Risk of Developing Aggressive Prostate Cancer, PATROL Study
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ClinicalTrials.gov Identifier: NCT04472338 |
Recruitment Status :
Recruiting
First Posted : July 15, 2020
Last Update Posted : December 9, 2022
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Condition or disease | Intervention/treatment |
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Prostate Carcinoma | Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration |
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.
After completion of study, participants are followed up annually.
Study Type : | Observational |
Estimated Enrollment : | 450 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | PATROL: Prostate Screening for Men With Inherited Risk of Developing Aggressive Prostate Cancer |
Actual Study Start Date : | May 21, 2020 |
Estimated Primary Completion Date : | August 31, 2023 |
Estimated Study Completion Date : | August 31, 2023 |

Group/Cohort | Intervention/treatment |
---|---|
Screening (biospecimen collection)
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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Procedure: Biospecimen Collection
Undergo collection of blood, urine, and/or tissue samples Other: Laboratory Biomarker Analysis Correlative studies Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
- Clinical variables as predictors of prostate cancer diagnosis [ Time Frame: Up to 3 years ]Descriptive statistics, parametric and non-parametric statistical tests will be used to summarize the clinical variables as predictors of prostate cancer diagnosis during the early detection study.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Provided documented informed consent according to local Institutional Review Board for acquisition of clinical and research specimens
- Documented germline pathogenic or likely pathogenic mutation/variant in a known or suspected cancer predisposition gene: BRCA2, BRCA1, ATM, CHEK2, PALB2, MLH1, MSH2, MSH6, PMS2, TP53, HOXB13, additional genes included at investigators discretion
- No prior diagnosis of invasive prostate adenocarcinoma
- No active malignancy within 1 year of entry. Active malignancy is defined as those malignancies requiring treatment with anti-cancer therapy or in the event of indolent malignancies, having measurable disease. Exceptions to this exclusion include: myelodysplasia, treated non-melanoma skin cancer, completely resected stage 0 or 1 melanoma, carcinoma in situ
- Life expectancy at least 5 years
- Participant is accessible and compliant for follow-up
- Willing and able to undergo screening procedures, including digital rectal exam (DRE) and prostate biopsy, if indicated by study criteria
Exclusion Criteria:
- Unwillingness, inability or medical contraindication to undergo screening procedures, including prostate biopsy, if indicated by study criteria
- Life expectancy < 5 years
- Prior diagnosis of prostate cancer

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): NCT04472338
Contact: Study Team Coordinator | 206-598-0850 | patrolstudy@uw.edu |
United States, Washington | |
Fred Hutch/University of Washington Cancer Consortium | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Study Team Coordinator 206-598-0850 patrolstudy@uw.edu | |
Principal Investigator: Heather H. Cheng |
Principal Investigator: | Heather H. Cheng | Fred Hutch/University of Washington Cancer Consortium |
Responsible Party: | University of Washington |
ClinicalTrials.gov Identifier: | NCT04472338 |
Other Study ID Numbers: |
RG1004195 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 ) |
First Posted: | July 15, 2020 Key Record Dates |
Last Update Posted: | December 9, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |