Clinical trial NCT04472338: Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
Official title: PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Carcinoma
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Canary Foundation
name: CureBRCA
First posted: 2020-07-15
Enrollment: 450
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Germline carriers of pathogenic or likely pathogenic mutations in genes associated with increased risk of prostate cancer

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* People with prostates ≥40 years of age
* Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk.

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.

Primary outcomes:
measure: Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Heather H. Cheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: