The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
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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 |
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 |
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.
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| 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 |
| 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 | |
| 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 Pathologic Processes Genital Neoplasms, Male |
Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013