An Exploration of Genetic Testing for Prostate Cancer Susceptibility

Prostate Cancer Clinical Trial

Official title:

An Exploration of Factors Affecting Interest and Uptake of Genetic Testing for Prostate Cancer Susceptibility: The Clinical Application of Genetic Testing for Lower Risk Cancer Predisposition Genes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00997464
• Other study ID #: CCR3200
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2009
• Last updated: October 16, 2009
• Start date: August 2009
• Est. completion date: February 2011

Study information

• Verified date: October 2009
• Source: Royal Marsden NHS Foundation Trust
• Contact: Dr Rosalind Eeles
• Phone: 02086613642
• Email: rosalind.eeles[@]icr.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 69 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease Susceptibility
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether cancer worry changes between the two time-points (measured using the Impact of Event Scale)			No
Secondary	Why are men interested/ not interested in seeking genetic profiling for prostate cancer, and what might be the uptake of such testing?			No
Secondary	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			No
Secondary	Is there a relationship between a family history of cancer, cancer worry, and a persons intention to seek genetic testing?			No
Secondary	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			No