Clinical trial: NCT00936390
Section: Alternatives
Subsections: What Other Choices Do I Have If I Do Not Take Part In This Study?

Your other choices may include:
- Getting treatment or care for your cancer without being in a study; this could include the following options, either alone or in combination with each other:
o Radiation therapy (external beam radiation therapy and/or brachytherapy) o Radiation therapy plus hormone therapy o Hormone therapy o Surgery
- Taking part in another study
- Getting no treatment Talk to your study doctor about your choices before you decide if you will take part in this study.
Clinical trial: NCT00936390
Section: Confidentiality
Subsections: Will My Medical Information Be Kept Private? (4/21/15)

Data are housed at NRG Oncology Statistics and Data Management Center in a password-protected database. We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.  
Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
- NRG Oncology
- The National Cancer Institute (NCI) and other government agencies involved in keeping research safe for people, like the Central Institutional Review Board (CIRB) and the Food and Drug Administration (FDA)
- The Cancer Trials Support Unit (CTSU), an organization sponsored by the NCI to provide greater access to cancer trials
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. [Note to Informed Consent Authors: the above paragraph complies with the new FDA regulation found at 21 CFR 50.25(c) and must be included verbatim in all informed consent documents. The text in this paragraph cannot be revised.]
Clinical trial: NCT00936390
Section: Duration of Study Involvement
Subsections: During The Study … (5/23/12)|How Long Will I Be In The Study? (5/23/12)

If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will need the following tests and procedures. They are part of regular cancer care.  
- Transrectal ultrasound assessment of the prostate (brachytherapy patients only)
- Blood tests to measure testosterone and liver function - An assessment of urinary symptoms and function (brachytherapy patients only)
- You will be asked to provide information regarding any cholesterol-lowering drugs you may be taking or have taken in the past
You will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can choose the group you will be in. You will have an equal chance of being placed in either group.  
If you are in group 1 (often called "Arm 1"): You will receive radiation treatments to the prostate gland and seminal vesicles once daily, 5 days a week, Monday through Friday, for a total of 44 treatments. Each radiation treatment will take approximately 20 minutes but may be specific to the center in which you are being treated. If you choose to receive brachytherapy (permanent or temporary radiation seed implant), the total number of daily treatment sessions will be 25. The logistics of the brachytherapy implant procedure (if you have chosen to undergo this type of treatment) should be thoroughly reviewed by your treating physician.  
If you are in group 2 (often called "Arm 2"): You will receive radiation treatments to the prostate gland and seminal vesicles as specified under group 1 above. You also will receive hormone therapy for 6 months. The hormone therapy will begin 2 months before the start of the radiation treatments. There are two parts to the hormone therapy. You will take injections of a luteinizing hormone releasing hormone (LHRH) agonist, either under the skin or in the muscle (typically every 1 to 3 months), and you will take a pill, either flutamide three times per day or bicalutamide once per day. The injected LHRH agonist will reduce the amount of circulating testosterone and the pill will interfere with the action of any remaining testosterone.

You will receive 44 radiation treatments over approximately 2 months. If you choose to receive the brachytherapy implant, you will receive 25 daily treatments plus the implant procedure over a timeframe of approximately 6 weeks. Hormone therapy, if given, will last 6 months. After you are finished receiving therapy, the study doctor will ask you to visit the office for follow-up exams at 3, 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter. The study doctors would like to keep track of your medical condition by seeing you every year for your lifetime.
Clinical trial: NCT00936390
Section: Participant's Rights
Subsections: What Are My Rights If I Take Part In This Study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution. We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.  
A Data Monitoring Committee (DMC) will be regularly meeting to monitor safety and other data related to this study. The Committee members may receive confidential patient information, but they will not receive your name or other information that would allow them to identify you by name. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.
Clinical trial: NCT00936390
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can I Expect From Being In The Study?|Less Likely|Less Likely|Rare, But Serious|Rare, But Serious|Less Likely|Less Likely|Rare, But Serious|Rare, But Serious|For More Information About Risks **And Side Effects, Ask Your Study Doctor.** Are There Benefits To Taking Part In The Study?|What Happens If I Am Injured Because I Took Part In This **Study?**|Risks

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, researchers don't know all the side effects that may happen. Side effects may be mild or very serious. These side effects may be related either to the radiotherapy, hormonal therapy (if randomized to receive it), or both. There are several radiotherapy options allowed on this study in the form of external beam radiation, low dose rate brachytherapy, and high dose rate brachytherapy.  
Each of these may be associated with subtle differences in their side effect profiles. The type of radiotherapy you receive on this study is a choice to be made between you and your physician. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop radiation or hormone therapy (if given). In some cases, side effects can be serious, long lasting, or may never go away.  
You should talk to your study doctor about any side effects that you have while taking part in the study.  
Risks and side effects related to the *radiation therapy* include those which are: Likely
- Increased urinary frequency or urgency
- Burning or discomfort/straining with urination - Increased frequency of bowel movements or change in stool consistency
- Increased straining/discomfort with bowel movements
- Mild fatigue

- Rectal bleeding (usually mild)
- Chronic bowel/bladder symptoms as described above
- Temporary blockage of urination requiring use of a catheter
- Erectile dysfunction For patients undergoing brachytherapy, risks associated with aspects of an invasive procedure such as those associated with anesthesia, infection, and bleeding must be considered and discussed with your treating physician. If permanent seed brachytherapy is used, there is a possibility of loss or migration of seeds leading to areas of under- or overdosage in certain parts of the prostate or elsewhere. Rectal or bladder complications may occur if these organs are affected because of seed misplacement.

- Headaches
- Bone/joint pain
- Liver toxicity (detected on a blood test) requiring reduced dose or stopping treatment
- Severe fatigue
- Skin rash/hives - Swelling  
- Decrease in bone mineral density
- There may be increased risk of rectal or bladder side effects as a result of the interaction between the hormone therapy and the external beam radiation therapy.

- Permanent rectal or bladder injury requiring surgery for treatment  
Risks and side effects related to the *hormone therapy* **include those which are:** (5/23/12)
Likely
- Hot flashes
- Erectile dysfunction
- Loss of libido
- Mild fatigue
- Breast tenderness or mild enlargement
- Diarrhea

- Severe allergic reaction
- Increased long-term risk of cardiovascular disease
- Increased long-term risk of developing diabetes
- Death due to heart disease Patients receiving treatment with LHRH agonists should undergo periodic monitoring of blood glucose and/or glycosylated hemoglobin (HbA1c) for signs of developing diabetes or worsening of blood glucose control in patients with diabetes, and also for the signs and symptoms suggestive of the development of cardiovascular disease.  
Reproductive risks: You should not father a baby nor donate sperm while on this study or during the first 3 months after the completion of therapy because the radiation and drugs in this study can affect an unborn baby. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Some of the drugs and radiation used in this study may make you unable to have children in the future.

- Rectal bleeding (usually mild)
- Chronic bowel/bladder symptoms as described above
- Temporary blockage of urination requiring use of a catheter
- Erectile dysfunction For patients undergoing brachytherapy, risks associated with aspects of an invasive procedure such as those associated with anesthesia, infection, and bleeding must be considered and discussed with your treating physician. If permanent seed brachytherapy is used, there is a possibility of loss or migration of seeds leading to areas of under- or overdosage in certain parts of the prostate or elsewhere. Rectal or bladder complications may occur if these organs are affected because of seed misplacement.

- Headaches
- Bone/joint pain
- Liver toxicity (detected on a blood test) requiring reduced dose or stopping treatment
- Severe fatigue
- Skin rash/hives - Swelling  
- Decrease in bone mineral density
- There may be increased risk of rectal or bladder side effects as a result of the interaction between the hormone therapy and the external beam radiation therapy.

- Permanent rectal or bladder injury requiring surgery for treatment  
Risks and side effects related to the *hormone therapy* **include those which are:** (5/23/12)
Likely
- Hot flashes
- Erectile dysfunction
- Loss of libido
- Mild fatigue
- Breast tenderness or mild enlargement
- Diarrhea

- Severe allergic reaction
- Increased long-term risk of cardiovascular disease
- Increased long-term risk of developing diabetes
- Death due to heart disease Patients receiving treatment with LHRH agonists should undergo periodic monitoring of blood glucose and/or glycosylated hemoglobin (HbA1c) for signs of developing diabetes or worsening of blood glucose control in patients with diabetes, and also for the signs and symptoms suggestive of the development of cardiovascular disease.  
Reproductive risks: You should not father a baby nor donate sperm while on this study or during the first 3 months after the completion of therapy because the radiation and drugs in this study can affect an unborn baby. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Some of the drugs and radiation used in this study may make you unable to have children in the future.

Taking part in this study may or may not make your health better. It is not known how much of a benefit combining hormone therapy with radiation therapy will have for your type of prostate cancer compared to the usual treatment. We do know that the information from this study will help researchers learn more about the combination of hormone therapy plus radiation therapy as a treatment for prostate cancer. This information could help future cancer patients.

It is important that you tell your study doctor, __________________ *[investigator's name(s)],* if you feel that you have been injured because of taking part in this study. You can tell the study doctor in person or call him/her at __________________ *[telephone number].*
You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health plan will be charged for this treatment. The study will not pay for medical treatment.

The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small.
Clinical trial: NCT00936390
Section: Procedures
Subsections: What Will Happen If I Take Part In This Research Study? Before You Begin The Study …|During Radiation Therapy Or Radiation Plus Hormone Therapy:|Study Plan

You will need to have the following exams, tests or procedures to find out if you can be in the study.  
These exams, tests, or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.  
- History and physical exam, including a digital rectal exam (DRE), an assessment of your ability to carry out activities of daily living (which will include questions such as whether you are able to feed, bathe, and dress yourself), and an assessment of other health conditions you may have (comorbidity).  
- Blood tests to determine your PSA (prostate-specific antigen) and for blood count. The PSA value is a number that helps determine the aggressiveness of your prostate cancer.  
- A CT (Computed Tomography) scan or MRI (Magnetic Resonance Imaging) of your pelvis and abdomen to determine if there is any evidence of cancer spread to the pelvic lymph nodes. A CT scan is a study using x-rays to look at one part of your body. An MRI is imaging using a strong magnetic field to look at one part of your body.  
- A bone scan (for some patients, if applicable) to determine if the cancer has spread to the bones

- You will be seen weekly during radiation treatment to check for any side effects you may be experiencing as a result of the treatment.  
- During the third week and the last week of radiation treatment, your ability to carry out activities of daily living (which will include questions such as whether you are able to feed, bathe, and dress yourself) will be assessed.  
- If you are receiving brachytherapy: Blood test for blood count during the first and fifth weeks of treatment
- If you are receiving hormone therapy: Blood test to measure testosterone; monthly blood tests for liver function When you are finished receiving radiation therapy or radiation plus hormone therapy, you will need these tests and procedures:
Sample consent form version: April 21, 2015  
- PSA measurement will be obtained at 6-8 weeks after finishing radiation treatment and prior to each follow-up visit.  
- A physical assessment, including a digital rectal exam (DRE) and an assessment of your ability to carry out activities of daily living (which will include questions such as whether you are able to feed, bathe, and dress yourself) at 3 (group 1 only), 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter.  
- If you receive hormone therapy: Testosterone levels will be checked every six months for three years or until they return to normal levels.  
- Additional testing may be ordered as deemed clinically appropriate by your treating physician.

Another way to find out what will happen to you during the study is to read the chart below. Start reading at the top and read down the list, following the lines and arrows.
Clinical trial: NCT00936390
Section: Purpose of Research
Subsections: Why Is This Study Being Done? (12/10/10)

The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer. Prior studies have suggested possible advantages to the administration of hormonal therapy with radiation. However, those studies were performed with radiation techniques that do not match those commonly used in clinical practice today (that is, dose-escalated radiotherapy). Therefore, we will be testing to see if similar benefits for hormonal therapy are seen when used with current radiation therapy techniques.  
In current clinical practice, either radiation therapy alone (called Arm 1 or Group 1 in this study) or radiation therapy combined with hormone therapy (called Arm 2 or Group 2 in this study) would be considered an acceptable standard treatment for patients with a newly diagnosed intermediate risk prostate cancer. The researchers conducting this study are testing the hypothesis that the side effects of hormonal therapy are outweighed by an advantage in prostate cancer cure rates for patients receiving that treatment. There are 2 treatment groups in this study: 1) Patients who receive radiation therapy only 2) Patients who receive radiation therapy plus hormone therapy If you agree to participate in this study, you will receive one of these 2 treatments.
Clinical trial: NCT00936390
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?

Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely.  
It is important to tell the study doctor if you are thinking about stopping so any risks from the radiation and hormone therapy (if given) can be evaluated by him/her. Another reason to tell your study doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you. The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest; if you do not follow the study rules; or if the study is stopped.