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Principal Investigators: 
Mrs. M.J. Roobol, Prof. Dr.
+31 10 70 33 271
Mr. C.H. Bangma, Prof. Dr. M.D.
+31 10 70 33 607
Database management:
Mr. Henk Luiting M.D.
+31 10 70 33 571
Site management:
Mr. W. Roobol
UK version PIF
  Thu 14 Sep 2006 (2778 )
PATIENT INFORMATION FORM

"Prostate cancer: active surveillance with the possibility for deferred treatment"


Dear participant,

Your physician has already informed you about participation in the above-mentioned medical research project. In order to make a careful decision whether to participate in this study we would like to provide further details. You can (re)read it and discuss it with relatives, friends and other people. If you have further questions about the project, please do not hesitate to contact one of the physicians mentioned in the last part of this form.

INTRODUCTION
Although prostate cancer is the most frequently diagnosed cancer type in older men, only a small proportion of those diagnosed with prostate cancer will die from it. Moreover most men who have prostate cancer, die with prostate cancer and not from prostate cancer. This is not only the result of the current early detection of prostate cancer, but also a result of the slow growth patterns most prostate cancers have. In some cases, prostate cancers have such a slow growth pattern men will not develop symptoms from their prostate cancer during their lives. Because we are increasingly capable of selecting these men at the time of diagnosis, an active surveillance strategy with the possibility of deferred curative treatment if it is necessary has been developed, and may be of benefit.

ACTIVE SURVEILLANCE
Active surveillance is the initial active observation of the cancer, rather than immediate active treatment (i.e. surgery or radiation of the prostate). Of course, only men who are selected according to our strict criteria are suitable for this. These criteria are the results of thorough research efforts. If you have these criteria, the risk of a fast growing prostate cancer is minimal.

In some instances the treating physician advises you to have a repeat biopsy in the weeks after diagnosis, to get additional information about your prostate cancer. However, it is still possible to participate in this project without the additional repeat biopsy. You can indicate this on the ‘informed consent’ form.

By regular PSA tests (Prostate Specific Antigen), physical examinations and repeat biopsies, your physician is provided with a lot of information about the state of your prostate cancer. At fixed moments in time, it is evaluated whether it is appropriate to continue on active surveillance or to undergo treatment for your situation. Page 3 of this form shows a time schedule, which indicates when you will receive which examination. If you choose active surveillance, it doesn’t mean you will not be treated, but treatment is only provided once you really seem to need it.

PURPOSE OF THE PROJECT
The goal of this research project is to study differences between men who elect immediate treatment and those who elect to postpone treatment for their prostate cancer. This will be measured by means of the need for treatment, spread of the cancer, death from prostate cancer and quality of life. Until now, the studies that have looked at this would suggest there is no difference between the two groups.

PRO’S AND CON’S OF ACTIVE SURVEILLANCE
As long as no treatment for your prostate cancer is needed, the major advantage of active surveillance is to avoid side effects which prostate cancer treatments can have, such as incontinence and/or impotence.

However, you should realize that by choosing active surveillance, you would be living with a cancer, which is initially not being treated. This knowledge can be an emotional burden for some men.

PROSTATE SPECIFIC ANTIGEN
PSA is a protein that is solely produced by the prostate. The amount of PSA available in blood is a measure for the amount of PSA produced by the prostate. Changes in the PSA level therefore roughly reflect the activity of your prostate cancer. Based on these changes in PSA, together with the physical examination and additional examinations if needed, your physician will advise you what to do.
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