An Exploration of Genetic Testing for Prostate Cancer Susceptibility

• Conditions: Prostate Cancer

• Registration Number: NCT00997464
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

Study of the factors that affect interest in - and uptake of - genetic testing for variants that predispose to prostate cancer from the perspective of the patient.

Detailed Description

This study will use a mixed methods approach to follow men as they move through the genetic testing process, from initial contact through to receiving their genetic testing results. A questionnaire will be used to measure variables at both baseline and after proceeding through the testing process. A small cohort of men will be invited to be interviewed to gather some in depth qualitative data about the issues that have arisen during the study process.

Study Timeline

• Study Start: 2009-08
• Status Verified: 2009-10
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-16
• Last Update Submitted: 2009-10-16
• Study First Posted: 2009-10-19
• Last Update Posted: 2009-10-19
• Primary Completion: 2011-02
• Study Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Men with a positive family history of prostate cancer. The definition of a positive family history will be: Men with a first degree relative with prostate cancer diagnosed at <70 years; Men with two relatives with prostate cancer where at least on is diagnosed at <70 years; Men with three relatives with prostate cancer diagnosed at any age
• Age 40-69 years
• No previous biopsy for raised PSA
• Absence of any psychological, familial, sociological or geographic situation potentially hampering compliance with the study protocol and follow-up schedule.

Exclusion Criteria

• Previous prostate cancer
• Men from families where there is known to be a mutation in a high-risk prostate cancer gene
• Men who have had a prostate biopsy within the last 12 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whether cancer worry changes between the two time-points (measured using the Impact of Event Scale)

Secondary Outcome Measures

Name	Time	Method
Why are men interested/ not interested in seeking genetic profiling for prostate cancer, and what might be the uptake of such testing?
What are the expectations of this testing from the perspective of the user, what are the perceived benefits and limitations of testing and how do these change through the testing process
Is there a relationship between a family history of cancer, cancer worry, and a persons intention to seek genetic testing?
How would the information provided by such a test be used by the individual and the family and how could this impact upon the healthcare system

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom