Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study

University of Washington

Status: Enrolling

Conditions: Prostate Carcinoma

Treatments: Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04472338

NCI-2020-04602 (Registry Identifier)

RG1004195 (Other Identifier)

P50CA097186 (U.S. NIH Grant/Contract)

8760 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

450 participants in 1 patient group

Screening (biospecimen collection)

Description:

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:

Procedure: Biospecimen Collection

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis