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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04472338




Registration number
NCT04472338
Ethics application status
Date submitted
10/07/2020
Date registered
15/07/2020

Titles & IDs
Public title
Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
Scientific title
PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease
Secondary ID [1] 0 0
NCI-2020-04602
Secondary ID [2] 0 0
RG1004195
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Biospecimen Collection
Other interventions - Laboratory Biomarker Analysis
Other interventions - Quality-of-Life Assessment
Other interventions - Questionnaire Administration

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.


Treatment: Surgery: Biospecimen Collection
Undergo collection of blood, urine, and/or tissue samples

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Other interventions: Quality-of-Life Assessment
Ancillary studies

Other interventions: Questionnaire Administration
Ancillary studies
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds
Timepoint [1] 0 0
Up to 10 years

Eligibility
Key inclusion criteria
* People with prostates =40 years of age
* Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk.
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Prior diagnosis of prostate cancer
* Medical contraindication to any of the study procedures (e.g., prostate biopsy)
* For all cancer types except non-melanoma skin cancer, any cancer treatment with curative intent within the past 12 months (e.g., surgery, radiation, chemotherapy, immunotherapy)
* Prior or concurrent participation in an interventional clinical trial aimed at preventing cancer for people with germline variants associated with increased prostate cancer risk
* Unable to provide written informed consent
* Unable or unwilling to complete clinical care and study procedures as indicated by the study protocol.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2030
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Other
Name
University of Washington
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canary Foundation
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
CureBRCA
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Heather H. Cheng, MD, PhD
Address 0 0
Fred Hutch/University of Washington Cancer Consortium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Team Coordinator
Address 0 0
Country 0 0
Phone 0 0
206-598-0850
Fax 0 0
Email 0 0
patrolstudy@uw.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04472338