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.

PRACTICAL ASPECTS OF ACTIVE SURVEILLANCE
If you choose active surveillance, a PSA test will be performed every three months in the first two years and every six months thereafter. These visits are called laboratory (lab) visits and you will not have direct contact with your physician. At 6, 12, 18 and 24 months, and annually thereafter evaluation visits will be scheduled. This means you will then visit your physician. Please find the time schedule on the next page. At the evaluation visits, not only a PSA test is performed, but a physical examination is performed as well. The physical examination includes a digital rectal examination. Additionally, after 1, 4, 7 and 10 years, and every five years thereafter a repeat biopsy is scheduled. You physician will explain and evaluate all parameters and will advise you what to do. If the situation is stable he will advise you to continue on active surveillance; otherwise deferred treatment is advised.

Years in which no standard biopsy is scheduled (table 1), a situation can occur in which the PSA-test and the physical examination will not provide the physician with enough information. In these circumstances, an additional repeat biopsy may be advised. Supported by the additional information from the biopsy, your physician can then provide you with a well informed advice about your prostate cancer.

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WHAT HAPPENS IF YOU DO NOT WANT TO PARTICIPATE?
If you decide not to participate in this project, you will receive standard care. Please note that this decision will not have any consequences for the quality of care you will receive. Alternative options can be discussed with your physician.

COSTS, FEE AND TIME INVOLVED
There are no extra costs associated with this research project. Furthermore will you not receive a fee for participation. The follow-up schedule for active surveillance is very similar to that after treatment, so the only additional time commitment of this study is the extra biopsies, but there are overall time savings for you because treatment is avoided or delayed.

CONFIDENTIALITY
Your personal information, which will be gathered for the study can only be accessed by a limited number of persons, and only after you have given a written consent for it. These persons are members of the research team, the medical inspection and members of the ethical board. Access can be necessary to study the quality and reliability of the research project. The law on protection of personal information and the privacy rules of the hospital will be obeyed.

A unique identification number will substitute personal information. Only that number will be used in analyses and scientific publications. Only those who know which number corresponds to which patient (the study physicians data managers and your physician) can make the link to you as a person. The data will be stored for 15 years after the research project has ended, but only if you give consent for it.

The board of directors of your hospital has approved this research project after the ethical board has studied and approved it. The international guidelines for this type of research will be obeyed carefully.

VOLUNTARY PARTICIPATION
Participation in this project is completely voluntarily. If you do not want to participate, you do not have to explain why. If you give us your consent, but after reconsideration decide that you do not want to participate anymore, it is possible to withdraw your consent at any time, without giving a reason. The research project will be executed by its initial plan, although there are circumstances in which we feel it is necessary to change the initial plan. In that case, modifications will be discussed with you; so you can decide whether you still want to participate. If your personal safety is in danger, your physician will end your participation to this project.

ADDITIONAL INFORMATION
Please feel free to contact your physician or the study physician if you have any questions or critics about the research project after having read this information. Questions can be directed to the following physicians:

For the Netherlands:
Drs. L. Bokhorst (MD), tel. +31 10 - 463 22 42
Drs. J. Salman (MD), tel. +31 10 - 463 22 43
Prof. dr. C.H. Bangma, urologist (MD, PhD), tel. +31 10 – 463 31 32

You can always contact the urologist on call by dialing the central hospital number:

If you are in doubt about participation to this project and want to talk to an independent physician, who has no connections to the project, please contact dr. P.C.M.S. Verhagen. He is an urologist at the Erasmus MC, University Medical Center and can be reached on tel. 010 -463 31 32. Dr. Verhagen can also be contacted if you have questions you would rather not pose to your own physician or the physician of the study.

If you are not content with the research project or the treatment received, you can contact the independent commission for complaints, which can be reached at tel. 010 – 463 31 98.