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

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

Recruiting
35 years and older
Male
Phase N/A

Overview

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.

Eligibility

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

Study details
    Malignant neoplasm of prostate

NCT04472338

University of Washington

16 February 2024

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