Download "L-SELENIUM-BASED CHEMOPREVENTION OF PROSTATE

IRB Approval Date ____________
Version: Amendment #3 8/30/05
SWOG S9917
Southeast Cancer Control Consortium Consent Form
L-Selenium-Based Chemoprevention of Prostate Cancer Among Men with High Grade Prostatic
Intraepithelial Neoplasia
What Is A Research Study?
This is a clinical trial (a type of research study). Clinical trials include only patients who choose to take
part. Please take your time to make your decision. Discuss it with your family and friends.
You are being asked to take part in this study because you are a man age 40 or older who has never had
prostate cancer. Approximately one man in ten in your age group will develop prostate cancer. You
have high grade prostatic intraepithelial neoplasia (HGPIN). HGPIN is a condition that places you at
higher risk for getting prostate cancer. It does not mean that you will develop prostate cancer.
Why Is This Study Being Done?
The purpose of this study is to determine whether l-selenomethionine (commonly called selenium) can
prevent prostate cancer.
This research is being done because currently there is no way to prevent prostate cancer.
How Many People Will Take Part In The Study
Nationally, about 1,165 men will take part in this study. It is expected that some will not continue on to
the second step because either cancer was found during the repeat biopsy or they decided not to
participate. It is expected that about 466 men will go on to the second step of the study.
What Is Involved In The Study?
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If you decide to take part in this study your first prostate biopsy must have had enough tissue obtained 6
months before starting this study. If it did not have enough tissue and you have not had a second
prostate biopsy in the 3 month period before starting this study, you may need to have another biopsy. If
needed, the repeat biopsy, which is specifically for this study, will be done to make sure that you do not
have cancer that was missed earlier. Tissue from your first biopsy that diagnosed HGPIN as well as all
other biopsies will be sent for central review, testing, and storage for future testing.
If your first biopsy contained enough tissue to confirm HGPIN but not cancer and if your second biopsy
(if one is required) confirms that you do not have cancer, you will go on to Step 2 of the study. What
you receive will be decided by a process called randomization. Randomization means that you are put
into a group by chance. It is like flipping a coin. Which group you are put in is done by a computer.
Neither you nor your doctor will know what group you will be in. You will have an equal chance of
being placed in either group. You will receive either selenium or placebo. A placebo is a tablet that
contains no medicine. For three years, you will take one tablet by mouth every day.
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Participant Initials ____
IRB Approval Date ____________
Version: Amendment #3 8/30/05
SWOG S9917
Southeast Cancer Control Consortium Consent Form
You will be asked to complete a form prior to going on the study. This form will ask you about your
prior vitamin use. You will also be asked to complete a form that asks you about your urinary function
among other things.
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Once you have been on study for six months, your doctor will evaluate you. At that time, you will be
asked if you are having any side effects. If you are not having any problems and are taking the tablets
regularly and desire to continue on the study, you will receive more tablets. You will be seen every six
months for three years. At each six month follow up visit, your doctor will perform a digital rectal
examination. During this exam, the doctor feels the surface of your prostate with a gloved finger for
irregularities that may be questionable for cancer. If this exam suggests that you may have prostate
cancer, your doctor may recommend that you have another prostate biopsy which would be part of
standard care. Between office visits (every 6 months), your doctor's office will call you to see how you
are doing and if you are having any side effects. You will also be asked about how often you are taking
your capsules.
Blood will be drawn at the start of the study and every six months after that. It will be examined for a
prostatic specific antigen (PSA) that may indicate that you have developed prostate cancer. If your PSA
blood test rises, your doctor may recommend another prostate biopsy.
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This blood sample will be also be looked at to determine the amount of selenium and nutrients in your
blood and how your body processes them. Blood that is left over will be stored for future testing.
You will continue on the study for three years. If prostate cancer is detected during the three years, you
will stop the study drug and will be treated as you wish. At the end of the study, a prostate biopsy will
be required as part of this study. The tissue removed from your prostate will be sent to a laboratory for
testing and storage.
It is anticipated that early prostate tumors may be found that might not have been found otherwise. It is
also possible that tumors that do not require treatment may be found. At this time it is difficult to tell the
difference between these types of tumors so it is possible that you may receive unnecessary treatment
which involves significant risks of side effects. You and your doctor will decide the treatment that you
will receive if prostate cancer is found during the study.
How Long Will I Be In The Study?
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We think you will be in the study for three years. We would like to follow you for ten years after you
start this study to look at the long-term effects of selenium or placebo.
The researcher may decide to take you off this study if your condition gets worse; if the side effects of
the selenium or placebo are too dangerous for you; or if new information about selenium or placebo
becomes available and this information suggests selenium or placebo will be ineffective or unsafe for
you. It is unlikely, but the study may be stopped early due to lack of drug supply or lack of funding.
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Page 2 of 6
Participant Initials ____
IRB Approval Date ____________
Version: Amendment #3 8/30/05
SWOG S9917
Southeast Cancer Control Consortium Consent Form
What Are The Risks Of The Study?
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Selenium is found in many foods. The dose of selenium for this study is not expected to cause you any
side effects or discomfort. However, long-term use of selenium has been known to cause mild nausea,
garlic breath, hair or nail changes, cough (symptoms of the common cold), bronchitis, dizziness,
weakness, skin redness or rash, irritability, and tiredness. One study did report an increased risk of nonmelanoma skin cancer (particularly squamous cell skin cancer) with selenium use in patients who had
previously had this disease. Side effects may be reversed by taking you off the study drug. There may
also be other side effects that we cannot predict or are unforeseen or unexpected.
While on the study, you are at risk for these side effects. You should discuss these with the researcher
and/or your regular doctor. There also may be other side effects that we cannot predict.
For more information about risks and side effects, ask the researcher or contact your regular doctor or
nurse.
Will I Benefit From The Study?
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We cannot and do not guarantee you will benefit if you take part in this study. The selenium or placebo
you receive may even be harmful. Your doctors feel that your participation in this study will give you at
least as good a chance as you might expect from other treatments. We hope the information learned
from this study will benefit other men in preventing prostate cancer in the future.
What Other Options Are Available?
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Instead of being in this study, you have the option not to participate on this study and receive more
frequent monitoring (observation).
Please talk to your regular doctor about these and other options.
What About Confidentiality?
Efforts will be made to keep your personal information confidential. We cannot guarantee absolute
confidentiality. Your personal information may be disclosed if required by law.
A record of your progress will be kept in a confidential form at your hospital or doctor's office where
you receive treatment. Organizations that may inspect and/or copy your research records (blood
samples, x-rays, scans, and pathology slides) for quality assurance and data analysis include groups such
as:
Southeast Cancer Control Consortium (SCCC) Operations Office
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Southwest Oncology Group (SWOG)
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
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Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
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Page 3 of 6
Participant Initials ____
IRB Approval Date ____________
Version: Amendment #3 8/30/05
SWOG S9917
Southeast Cancer Control Consortium Consent Form
Possible other federal or state government agencies
If your record is used or given out for governmental purposes, it will be done under conditions that will
protect your privacy to the fullest extent possible consistent with laws relating to public disclosure of
information and law-enforcement responsibilities of the agency.
You authorize the use of clinical information, contained in your records, but any publication which
includes such information or data shall not reveal your name, show your picture, or contain any other
personally identifying information, except as otherwise required by law.
What Are The Costs?
Taking part in this study may lead to added costs to you or your insurance company. You or your
insurance carrier will be responsible for the costs of clinic visits, any hospital admissions, laboratory
tests, x-rays, scans, and any other tests. Please ask your doctor about any added costs or insurance
problems. You will not be paid to participate in this study.
Administration of the drug will be charged in the usual way. The parts of the research consisting of
keeping research records will be paid by those organizing and conducting the research. The research
requires that you receive certain standard medical tests and examinations. These standard tests and
examinations will be charged in the usual way.
In the case of illness resulting from this study, emergency medical treatment is available but will be
provided at the usual charge. No funds or monies have been set aside to compensate you in the event of
injury.
You or your insurance company will be charged for continuing medical care and/or hospitalization.
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The Chemoprevention Branch of the National Cancer Institute will provide you with the research drug(s)
l-selenomethionine (an amino acid containing selenium) or the matching placebo free of charge for this
study.
What Are My Rights As A Participant?
Taking part in this study is voluntary. You may choose not to take part or you may leave the study at
any time but we encourage you to talk to your doctor first. Leaving the study will not result in any
penalty or loss of benefits to which you are entitled. If you withdraw from the study, you will continue
to be followed and clinical data will be collected from your medical records. You are free to seek care
from a doctor of your choice at any time.
We will tell you about new information that may affect your health, welfare or willingness to stay in this
study.
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Participant Initials ____
IRB Approval Date ____________
Version: Amendment #3 8/30/05
SWOG S9917
Southeast Cancer Control Consortium Consent Form
A Data Safety and Monitoring Board, an independent group of experts, will be reviewing the data from
this research throughout the study. We will tell you about important new information from this or other
studies that may affect your health, welfare, or willingness to stay in this study.
Who Do I Call If I Have Questions Or Problems?
For questions about the study or a research-related injury, contact your doctor, ______________, at #
__________________. You may ask your doctor for further information on the risks, benefits or
alternative treatments.
For questions about your rights as a research participant, contact the ______________________
Institutional Review Board (which is a group of people at the hospital in the community where you
receive treatment who review the research to protect your rights) at # __________________ (the office
of ______________________).
Where Can I Get More Information?
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You may call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) or
TTY: 1-800-332-8615 or you may visit the Cancer Information Service Website:
http://www.cancer.gov/cis
You may visit the NCI’s Web site:
http://www.cancer.gov
This website contains comprehensive clinical trials information and accurate cancer information.
Patient Contract
I have been offered the opportunity to ask questions about this study and all questions have been
answered to my satisfaction. The contents of this form have been explained to me and I understand
them. I agree to allow the research personnel specified above the access to my medical records.
It may be necessary for my doctor to contact me at a future date regarding new information about the
study; therefore, I agree to notify my doctor of any change of address and/or telephone number.
My signature below means that I have voluntarily agreed to participate in this research study. A copy of
this consent form has been given to me.
_______________________
(Date)
2/1/00
_____________________________________________
(Participant Signature)
Page 5 of 6
IRB Approval Date ____________
Version: Amendment #3 8/30/05
SWOG S9917
Southeast Cancer Control Consortium Consent Form
8/30/05
1) My blood and tissue may be kept for use in research to learn about, prevent, treat or cure cancer.
Yes _____
No _____
Initial _____
8/30/05
2)
My blood and tissue may be kept for research about other health problems (for example: causes of
diabetes, Alzheimer’s disease, and heart disease).
Yes _____
No _____
Initial _____
8/30/05
3)
Someone may contact me in the future to ask me to allow other uses of my blood and tissue.
Yes _____
No _____
Initial _____
I certify that I have explained to the above individual the nature and purpose, the potential benefits, and
possible risks associated with participation in the research study and have answered any questions that
have been raised.
__________________
(Date)
2/1/00
______________________________________
(Signature of Person Obtaining Consent)
Page 6 of 6
Participant Initials _____
SWOG S9917
Southeast Cancer Control Consortium Withdrawal of Consent
I, __________________________ , withdraw my consent to participate in SWOG S9917 and refuse to
be followed and have clinical data collected from my medical records.
Participant Name __________________________ SWOG Pt. Number ___________________
(Please Print Name)
Participant Signature ______________________________ Date _______________
Witness Signature ________________________________ Date _______________
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SWOG S9917
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
I, _____________________________, withdraw my consent for treatment on SWOG S9917. Even
though I withdraw my consent for treatment, I will continue to be followed and clinical data will be
collected from my medical records.
Participant Name _______________________
(Please Print Name)
SWOG Pt. Number ___________________
Participant Signature _________________________________
Date _______________
Witness Signature ________________________________ Date _______________
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