IMPACT

IMPACT, an international collaboration currently involving over 20 countries, aims to investigate the role of targeted prostate cancer screening in male BRCA1 and BRCA2 mutation carriers. 500 BRCA1 carriers, 350 BRCA2 carriers, and 850 controls (men who have tested negative for a pathogenic BRCA1 or BRCA2 mutation which is known to run in the family) will be recruited. (For more information please refer to our participant eligibility criteria.) The ERSPC study (European Randomized study of Screening for Prostate Cancer) and the British ProtecT study (Prostate testing for Cancer and Treatment) will also provide age matched controls.

Participants will take part in a targeted screening programme which is expected to run for a minimum of five years. They will be asked to undergo an annual blood PSA test and provide a urine specimen at their local research centre. Blood PSA levels will be analysed both locally and at a central reference laboratory to ensure quality control and standardisation of results.

Any participant with a blood PSA level above 3.0ng/ml will be offered a ten-core prostatic biopsy. A further 2 cores will be taken for research. Specific guidelines on how the biopsy should be performed are available in the IMPACT study protocol. (Please refer to the PSA screening section for an explanation of why the PSA threshold for biopsy was set at 3.0ng/ml).

If prostatic intraepithelial neoplasia (PIN) is found, or if the results of the biopsy are inconclusive, participants will be asked to undergo another biopsy after six weeks. Participants with a negative biopsy will be asked to continue with their annual PSA tests and will only be referred for a repeat biopsy if their PSA value increases by at least 50%.

Participants with a positive biopsy will be referred to their local urologist for treatment according to local policy and these patients will be monitored for at least five years after the trial has ended. Please refer to the Patient Journey section for more information.

In an attempt to identify new modifier genes or biomarkers for this population, whole blood, lymphocytes, serum, plasma, urine and prostate tissue specimens will also be collected where appropriate. These will be analysed using biochemical, proteomic, metabonomic and microarray approaches.

Additional information about the IMPACT study is available in the IMPACT study protocol, and other study documents, which can be accessed through the restricted area of this site. The restricted area is for use by current and potential IMPACT collaborators only. If you are considering joining the IMPACT study, and would like access to the restricted section of this site, please complete the on-line Registration form.

We have also provided a list of Frequently Asked Questions and IMPACT study publications for your information.

If you require more information about IMPACT, or you are interested in joining the study, then please contact the IMPACT coordinator. There is a list of criteria that research centres need to meet before they are eligible to join IMPACT, and the IMPACT study coordinator will be happy to discuss this with you.

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