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The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Institute of Cancer Research, United Kingdom
Sponsor:
Collaborators:
Cancer Research UK
Royal Marsden NHS Foundation Trust
Ronald and Rita McAulay Foundation
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT00261456
First received: December 1, 2005
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

The IMPACT study is an international targeted prostate screening study of men at increased prostate cancer risk due to the presence of known pathogenic mutations in BRCA1 and BRCA2 genes.

There are only approximately 150 men with a known BRCA1 or BRCA2 mutation in the UK. Research has shown that these men are at an increased risk of developing prostate cancer but more information is needed about the pathogenesis of prostate cancer in this defined group and the role of screening in these men. The study will offer annual PSA screening to these men to determine the incidence of prostate cancer in this group. The study will also look at new markers of early prostate cancer in this cohort.

The power calculations for this study are 850 carriers and 850 controls (age-matched men without BRCA1/2 mutations). It is therefore essential to gain international collaboration to meet the target of recruiting 850 men with these known mutations and a control group of 850 men who have tested negative for a known familial mutation.


Condition Intervention
Prostate Cancer in BRCA1 and BRCA2 Carriers
Behavioral: PSA test
Procedure: Prostate Biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer: Targeted Screening in BRCA1/2 Mutation Carriers & Controls

Resource links provided by NLM:


Further study details as provided by Institute of Cancer Research, United Kingdom:

Biospecimen Retention:   Samples With DNA

Whole blood, Serum, Plasma, Urine, Prostate tissue.


Estimated Enrollment: 1700
Study Start Date: October 2005
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BRCA1/2 carriers
Carriers of a BRCA1 or BRCA2 mutation.
Behavioral: PSA test
Patients tested for their level of Prostate Specific Antigen.
Procedure: Prostate Biopsy
A Prostate biopsy is given as an option to the patient if their PSA level is raised or at the end of 5 years screening.
BRCA1/2/non Carriers
Do not carry a mutation in either the BRCA1 or 2 genes that has been found in other members of the family.
Behavioral: PSA test
Patients tested for their level of Prostate Specific Antigen.
Procedure: Prostate Biopsy
A Prostate biopsy is given as an option to the patient if their PSA level is raised or at the end of 5 years screening.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Any patient that meets the eligibility criteria and maybe attending a genetics clinic at a number of international centres that have gone through ethical approval.

Criteria

Inclusion Criteria:

  • Male carriers of a known pathogenic BRCA1/2 mutations or men testing negative for a known BRCA1/2 mutation in their family
  • Aged between 40-69 years old
  • WHO performance status 0-2
  • No previous history of prostate cancer
  • No previous prostate biopsy for raised PSA
  • Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule
  • Fully informed, written consent according to ICH/EU GCP and national/local regulations before subject registration.

Exclusion Criteria:

  • Previous cancer with terminal prognosis of less than 5 years
  • Previous prostate cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261456

Contacts
Contact: Rosalind A Eeles, FRCP FRCR 44 208 661 3642 rosalind.eeles@icr.ac.uk
Contact: Elizabeth K Bancroft, RGN MMedSci 44 207 808 2136 elizabeth.bancroft@rmh.nhs.uk

Locations
United Kingdom
Cancer Genetics Unit, Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Rosalind A Eeles, FRCP FRCR    44 208 661 3642    rosalind.eeles@icr.ac.uk   
Contact: Elizabeth K Bancroft, RGN MMedSci    44 207 808 2136    elizabeth.bancroft@icr.ac.uk   
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Cancer Research UK
Royal Marsden NHS Foundation Trust
Ronald and Rita McAulay Foundation
Investigators
Principal Investigator: Rosalind A Eeles, FRCP FRCR Institute of Cancer Research and Royal Marsden Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT00261456     History of Changes
Other Study ID Numbers: 05/MRE07/25, CCR2598
Study First Received: December 1, 2005
Last Updated: November 27, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Institute of Cancer Research, United Kingdom:
Prostate cancer
BRCA1
BRCA2
prostate screening
PSA
prostate biopsy

Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease
Prostatic Neoplasms
Disease Attributes
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014