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

Prostate Carcinoma Clinical Trial

Official title:

PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04472338
• Other study ID #: RG1004195
• Secondary ID: NCI-2020-0460287
• Status: Recruiting
• Start date: May 21, 2020
• Est. completion date: August 31, 2030

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: Study Team Coordinator
• Phone: 206-598-0850
• Email: patrolstudy[@]uw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: August 31, 2030
• Est. primary completion date: August 31, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

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)

• Unable to provide written informed consent

• Unable or unwilling to complete clinical care and study procedures as indicated by the study protocol.

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood, urine, and/or tissue samples

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Canary Foundation, CureBRCA, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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