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

  • STATUS
    Recruiting
  • participants needed
    450
  • sponsor
    University of Washington
Updated on 19 February 2024
cancer
measurable disease
adenocarcinoma
cancer treatment
carcinoma
cancer therapy
digital rectal examination
digital rectal exam
adenocarcinoma of prostate
prostate carcinoma
biopsy of prostate
prostate cancer
CHEK2
ATM
BRCA1
PMS2
MSH2
BRCA2

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.

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.

Details
Condition Malignant neoplasm of prostate
Age 35years - 100years
Treatment Questionnaire Administration, Quality-of-Life Assessment, Biospecimen Collection, Laboratory Biomarker Analysis
Clinical Study IdentifierNCT04472338
SponsorUniversity of Washington
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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 mutations 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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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