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

STATUS

Recruiting
participants needed

450
sponsor

University of Washington

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Updated on 19 February 2024

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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 Identifier	NCT04472338
Sponsor	University of Washington
Last Modified on	19 February 2024

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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

How to participate?

Step 1 Connect with a study center

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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

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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Step 4 Get your study results

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