Researcher's Frequently Asked Questions

A1. My centre is interested in joining the IMPACT study – what is the next step?

If you are interested in joining the IMPACT study, please contact the IMPACT coordinator directly by phone, email or written correspondence. Unfortunately the IMPACT coordinator is only able to correspond in English. If this is not convenient, it may be worth looking at the local contact information section for the contact details of a local member of the IMPACT team.

A2. I am a Clinician/Researcher considering taking part in IMPACT. What departments/personnel do I need to have contact with in order to participate in IMPACT?

In order to be able to recruit patients, a centre interested in participating in IMPACT must have access to the following: A Geneticist, Oncologist, Urologist, and someone to co-ordinate the research. If you are interested in participating in the new Prostate Cancer markers part of the study you must also have access to laboratory facilities (centrifuge and -80°C freezer).

Some members of the IMPACT team are only involved in an advisory capacity however, and are not directly involved in patient recruitment. If you are unable to recruit patients but are interested in participating, please contact us.

A3. How is the IMPACT study funded?

Funding has been secured to carry out IMPACT in Australia. We are currently in the process of applying for funding for all other centres, but, where possible, we would be grateful if you could explore the option of securing funding locally.

A4. Is the IMPACT study currently being run in my country?

A list of all the Research Centres, with contact details, which are currently participating in the IMPACT study, is available in the local contact information section of this website. For each country involved in the study a chief investigator will be appointed, the contact details of whom will also be listed in the local contact information section.

A5. What does being the principle investigator for IMPACT in my country entail?

The Institute of Cancer Research (ICR) is the main sponsor of the IMPACT study, and Dr Rosalind Eeles is the project's Chief Investigator, but in each country a principal investigator will be appointed to ensure that all centres within that country comply with the IMPACT guidelines. The institution which employs this individual will take responsibility, as the local sponsor organisation, to set up agreements between the collaborating centre and the ICR indicating their consent to comply with European Good Clinical Practice guidelines; two documents, the Material Transfer Agreement and Sponsorship Agreement will need to be signed by ICR and the local site before recruitment can commence (these documents are available for download in the restricted section of the website - appendix P and Appendix Q of the protocol respectively).

A6. How long will the IMPACT study be running?

The IMPACT study is expected to run for at least 10 years in the first instance. Participants will have their PSA levels monitored annually for a total of 5 yrs, and will be followed up for a further 5 yrs. Ethical approval has been obtained in the UK for the first 5 years, and an application for the follow-up will be submitted at the end of this period.

A7. How will IMPACT study participants be recruited?

Men who are eligible to take part in the study are identified and contacted through collaborating genetics clinics. They are given a copy of the patient information sheet, which they are asked to read. If they express interest in participating in the study, an appointment is made with a member of the local research team to discuss the project and answer any question(s) the patient may have. The patient is asked to sign a consent form before he is allowed to take part.

A8. What information is available for IMPACT study participants?

There are several sources of information available to the participant including the public information section of this website and patient information sheet (to aid accessibility these will be translated into French, German and Polish during the initial phase of website development). Further languages may follow.

There is also a local telephone contact point, details of which can be found in the local contact information section of this website.

A9. What are the eligibility criteria for IMPACT participants?

Full details of the IMPACT study’s eligibility criteria are available in both the Researcher and Public sections of this website.

A10. What PSA level will be used as the threshold for biopsy, and why has this threshold been chosen?

The IMPACT Steering committee has decided to set the threshold for biopsy at 3ng/ml, which is in line with that of the ERSPC European and ProtecT UK screening studies. One widely accepted threshold for biopsy is 4.0ng/ml, but because IMPACT will be screening a relatively young population of men (a younger age of onset can be seen in this population of men), and PSA level is age-related, a lower threshold was felt to be appropriate to maximise prostate cancer detection at the earliest possible stage.

A11. What alternatives to the PSA Screening tests will the IMPACT study investigate?

There has been considerable debate over the reliability of PSA as a marker of prostate cancer (please refer to the PSA Screening section of this website for further information). IMPACT will be investigating several new markers of prostate cancer in the research setting and in collaboration with other research groups. This is the reason why blood and urine samples are collected for research.

A12. Why are both urine and blood samples taken annually?

The results of the ERSPC and ProtecT studies have suggested an appropriate PSA level for biopsy in the general population to be 3.0ng/ml with a screening interval of 4 years. (Otto and de Koning, 2004; Postma et al, 2004).

It is believed that the population of men which is being targeted by the IMPACT study may have a higher risk of developing prostate cancer (and develop it at an earlier age). We will use a screening interval of one year to establish a pattern of PSA in each individual over a 5 year period and see if this is different between the case and control groups. In addition, blood and urine samples are taken with the aim of investigating potential new markers of prostate cancer, which could be used in addition to the PSA test.

A13. How should the blood/urine samples be stored, and what happens to them after they’ve been taken?

Each centre will need to identify someone locally who is able to process the samples:

1. The samples are collected and processed as per sample collection protocol (see Appendix G of the IMPACT protocol, which is available for download in the restricted section of this website). Access to a -80C freezer and a centrifuge are necessary.

2. The blood for the PSA test should be sent to your local biochemistry lab.

A14. What happens to a patient who is found to have a raised PSA?

Patients with a raised PSA will be referred to an urologist for biopsy. The biopsy should be carried out using specific IMPACT guidelines (see appendix H of the IMPACT protocol, which is available for download in the restricted section of this website). The urologist will take 10 biopsy cores, plus two extra for research purposes with the patient’s consent. If cancer is detected, treatment will be carried out according to local guidelines.

A15. What happens if the PSA quality control test demonstrates a PSA of over 3ng/ml but the local biochemistry lab shows the PSA to be under 3ng/ml?

This is very unlikely to happen as all of the centres undergo regular quality control by a central laboratory based in the UK. Clinical intervention will be guided by the local result, but if this does happen to be very different, we will discuss the situation with your doctors and yourself.

A16. Why aren’t carriers of other prostate cancer predisposition genes being targeted?

Previous published research has suggested that these two genes are linked to an increased risk of prostate cancer. In some populations there have been reports that alterations in other genes may predispose to prostate cancer. These leads will be looked at in other populations to determine if they confer an increased risk in other countries. At the moment IMPACT is recruiting carriers of alterations in BRCA1 and BRCA2 but in other countries other gene alteration carriers may be included as these data are published.

A17. I am interested in taking part in the IMPACT study but BRCA testing does not currently take place in my country. What assistance can be offered to me?

We suggest that you may want to contact an existing collaborator for advice on how to set up BRCA testing in your country or access it from elsewhere or contact the IMPACT coordinator.

A18. How should the prostate biopsies be performed?

Prostate biopsy should be carried out using specific IMPACT guidelines (see appendix H of the IMPACT protocol, which is available for download in the restricted section of this website). The urologist will take 10 biopsy cores, plus two extra for research purposes only, with the Patient’s consent.

A19. Why is there a special protocol for the prostate biopsies?

A special protocol for prostate biopsy (see appendix H of the IMPACT protocol, which is available for download in the restricted section of this website) has been recommended to ensure standardisation of prostate cancer detection and research. The steering committee has decided on this specific protocol based on considerations of best practice.

We would like to hear from you if you have a question which you feel should be included in the Frequently Asked Questions section of this website.

Please email any suggestions to the IMPACT website administrator (in English only please).

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