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