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Prostate Screening for Men With Inherited Risk of Developing Aggressive Prostate Cancer, PATROL Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04472338
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This study investigates ways to detect prostate cancer earlier in men who are at increased genetic risk of developing prostate cancer 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.

Condition or disease Intervention/treatment
Prostate Carcinoma Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration

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.

After completion of study, participants are followed up annually.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.
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




Primary Outcome Measures :
  1. 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
Blood, urine, tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
Germline carriers of pathogenic or likely pathogenic mutations in genes associated with increased risk of prostate cancer: (BRCA2, BRCA1, CHEK2, PALB2, ATM, HOXB13, MSH2, MSH6, MLH1, PMS2, TP53)
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Study Team Coordinator 206-598-0850 patrolstudy@uw.edu

Locations
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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         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Heather H. Cheng Fred Hutch/University of Washington Cancer Consortium
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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 )
P30CA015704 ( U.S. NIH Grant/Contract )
P50CA097186 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases