Clinical trial: NCT02614859
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Choices Do You Have If You Do Not Take Part In This Research Study?

Taking part in this study may or may not make your health better. While doctors hope that use of metformin combined with bicalutamide will be more useful against cancer compared to the usual treatment, there is no proof of this yet. We do know that the information from this study will help doctors learn more about combination of metformin and bicalutamide as a treatment for cancer. This information could help future cancer patients.

Your other choices may include:
Getting treatment or care for your cancer without being in a study Taking part in another study Getting no treatment
Talk to your doctor about your choices before you decide if you will take part in this study.
Clinical trial: NCT02614859
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?

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:
Fox Chase Cancer Center and affiliated Joint Centers, The Institutional Review Boards of The Fox Chase Cancer Center and Temple University, Temple University, Temple University Health system, Inc., and its affiliates or subsidiaries and other authorized representatives of these organizations.  
The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people
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. You will be given a separate form to review regarding the steps we will take to guard your privacy as part of your participation in the research study. By signing that additional authorization, you will be providing your consent to use and disclose information described in that form connected with your participation in this research study.
Clinical trial: NCT02614859
Section: Duration of Study Involvement
Subsections: After You Are Finished Study Treatment. Irb: Page 7 Of 18|How Long Will You Be In The Research Study?

Your doctor will follow you regularly after completion of your treatment to access your disease status and health. During the time that you are on study, you will be followed every cycle (4 weeks) for medical monitoring and testing. After going off-treatment, you will be followed every 12 months until you are on study for 5 years.

Your drug treatment on this research study ends at the finish of Cycle 8 (week 33), unless your doctor decides that you are candidate for additional treatment. After you are finished taking study medication the study doctor will ask you to visit the office for follow-up exams for at least every 12 months for 5 years. We will keep track of your overall condition annually for up to 5 years. If we do not see you in office, we would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking on your condition every year helps us look at the long-term effects of the study.
Clinical trial: NCT02614859
Section: Participant's Rights
Subsections: What Are Your Rights If You Take Part In This Research Study?

Taking part in this research study is your choice. You may choose either to take part or not to take part in the research 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. 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: NCT02614859
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can You Expect From Being In The Research Study?|Less Likely (5% To 19%)|Radiation Risk For Diagnostic Imaging|Blood Draw Risks|Reproductive Risks|What If You Are Injured While Taking Part In This Research Study?|Benefits|Risks

You may have side effects while on the research study. Everyone taking part in the research study will be watched carefully for any side effects. However, doctors don't know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop taking the drugs. In some cases, side effects can be serious, long lasting, or may never go away. There is also a risk of death. You should talk to your study doctor about any side effects that you have while taking part in the research study. Risks and side effects related to the **metformin** include those which are:  
Likely (>20%)
Diarrhea (increased frequency of bowel movements with loose, watery stools)
Nausea (feeling sick to your stomach) Vomiting (throwing up)
Less Likely (5-19%)
Abdominal Pain Abdominal Distention (enlarged/swollen) Indigestion Passing gas Headache Tiredness
Lactic acid build up which may cause muscle aches, shortness of breath, or severe belly pain Risks and side effects related to **bicalutamide** as listed below are risks observed when used in combination with other drugs for prostate cancer and may not affect your experience in this study.  
Risks and side effects related to the **bicalutamide** include those which are:

Loss of sexual desire Not able to have or to keep erection during sexual intercourse Nausea - feeling sick to your stomach Diarrhea - increased frequency of bowel movements with loose, watery stools Belly pain Constipation - difficulty having a bowel movement Elevated liver enzymes: Liver enzymes are proteins made by the liver that are measured in the blood, with a blood draw. Liver enzymes indicate how well your liver is functioning. Elevated liver enzymes may cause no symptoms, however higher liver enzyme levels may cause you to feel overly tired or weak, you may bruise or bleed more easily, and you may experience abdominal pain or have a yellowing of the skin or eyes.  
Chest pain Hypertension (high blood pressure) Symptoms may include headache, dizziness, palpitations, blurred vision, ringing in the ears and nose bleeds Swelling of your arms or legs Anemia (low hemoglobin, low hematocrit or low red blood cell count) Red blood cells carry oxygen and nutrients throughout the body. Symptoms that may be experienced as a result of low red blood cell counts may include feeling tired and weak, shortness of breath, increased heart rate, dizziness or lightheadedness, headache, chest pain and pale skin Hyperglycemia (high blood sugar) Symptoms of high blood sugar may include increased hunger, increased thirst, dry mouth and increased urination Bone pain Muscle pain and weakness Rash Shortness of breath Dizziness Headache Difficulty sleeping Change in appetite, weight loss or weight gain Presence of blood in the urine Excessive urination at night Likely (≥ 20%)
Hot flashes Back pain Constipation - difficulty having a bowel movement Generalized pain Tiredness Pelvic Pain Rare but serious (< 5%)
Heart failure - a lowered ability of the heart to pump blood Severe liver damage Bone fractures

It is unlikely that there will be any harmful effects from the radiation exposure you will receive from participating in this study.  
At high levels of exposure, scientists agree that radiation can cause cancer.  
At low exposure levels most scientists agree that the risk, if any, is very low. You will have low levels of radiation exposure with diagnostic imaging procedures.

Fainting Bleeding Bruising at the place on your arm where the blood was drawn or needle inserted Pain Swelling Infection (rare)
Biopsy **Risks**
Bleeding Pain Infection, which can be life-threatening or fatal in rare cases

Study treatments may make you sterile (unable to have children)
The drugs in this study may affect a baby, before or after the baby is born Frequent urination during the day Difficulty urinating Infection Flu symptoms Indigestion: discomfort in abdomen including bloating, discomfort, nausea and burping Passing gas Vomiting Sweating Joint tenderness, pain, and stiffness Anxiety Cough Sore throat (pharyngitis) Bronchitis: inflammation of the airways that carry air into your lungs resulting in a cough often with mucus, shortness of breath, wheezing, low fever and feelings of tightness in the chest Abnormal tingling, pricking, chilling, burning or numb sensation on the skin with no apparent physical cause Urinary Tract Infection (UTI)  
You should not father a baby while on this research study because the drugs you take could possibly hurt an unborn baby If you become pregnant while you are on the research study, you may not continue to take part in the research study For men:
You should not make a woman pregnant while you are in this study Check with the study doctor about birth control methods and how long to use them.  
Some methods might not be approved for use in this study

If you are injured as a result of your participation in this research study, seek immediate medical care. Temple University Health System or its subsidiaries will treat the injury, though there is no commitment to provide monetary compensation or free medical care. Other financial compensation (such as lost wages or pain and suffering) for such injuries is not available. 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.

The benefits of research using tissue include learning more about what causes cancer and other diseases, how to prevent them, and how to treat them.  
You will not receive any benefit from these possible results.

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: NCT02614859
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study? Before You Begin The Research Study|During The Research Study|Tests And Procedures|Questionnaires

You will need to have the following exams, tests or procedures to find out if you can be in the research study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the research study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.  
Physical examination (This exam will include checking your heart rate, blood pressure, and temperature and measuring your height and weight)
Review of your current medications, medical history, and performance status (evaluation of how active you are)
Blood test to measure your blood counts, kidney function, liver function, fasting lipids, blood sugar, blood insulin levels, blood mineral levels, Vitamin B12, PSA and testosterone (about 2 table spoons)
Scans of your body (bone scan, CT chest/abdomen/pelvis, and/or Chest x-ray)
o A CT scan is a computerized x-ray that gives your study doctor pictures of the inside of your body o A bone scan requires an injection of a radioactive material into a vein. A special camera will then take a picture of all your bones while you lay very still on a table You will undergo the following procedures that are not part of regular cancer care and are being done only because you are in this study.  
Blood test for glycosylated hemoglobin (HgbA1C) to see if you have diabetes and o If you do, how well it is controlled Fasting blood test to measure glucose levels (about 1.4 teaspoon) Fasting blood tests to measure insulin levels (about 2.7 teaspoon) Blood for research (about 5 table spoons) A Quality of Life Questionnaire

For the purposes of this study, each 4-week period is considered a "cycle". Each cycle is numbered in order. Please see study chart below for more information about what will happen to you during Cycle 1 and future treatment cycles.

If you choose to be and tests show you can be a part of this research study you will have the following tests, exams and procedures during the research study. If the exams, tests and procedures show that you can be in the research study, and you choose to take part, then you  
will need the following tests and procedures. They are part of regular cancer care. They are being done more often because you are in this research study.  
Physical examination and performance status Review of your current medications and side effects Routine blood test to measure your blood counts, kidney function, liver function, fasting lipids, PSA and testosterone (about 2 tablespoons)
Blood draws for additional testing related to the clinical trial (about 2.5 tablespoons)
Blood draw for research purpose (about 5 table spoons, taken once)
You will be asked to provide samples of your tumor tissue (if available from a previous surgery or biopsy) and some of your blood for testing. You can still participate in this study even if you do not give permission for your tumor tissue and your blood to be submitted and used for this optional research. For more information on this research, please see the last three sections of this document. One section provides general information about the collection and use of specimens for research. Another section describes specific information about the use of specimens for this research study. The last section focuses on issues regarding future research. You will be "randomized" into one of the research study groups (called "Arms") described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the research study groups. Neither you nor your doctor can choose the group you will be in. You will have an equal chance of being placed in any group. Whether you are randomized to Arm A or to Arm B, you will be given a Patient Pill Diary for each cycle to keep a record of the pills you take each day, any side effect you developed, any other medications you are taking or anything else you would like e to tell your doctor about.

We are asking you to fill out questionnaires for this research study. These questionnaires will tell us about your quality of life. You will spend 15 minutes to fill out the questionnaires. We will ask you to fill them out 2 times during this research study. You do not have to answer any questions that make you uneasy. Whether or not you answer any question will not affect your medical care. We will keep the paper copies of the questionnaires in a locked file to protect your privacy.
Clinical trial: NCT02614859
Section: Purpose of Research
Subsections: Why Is This Research Study Being Done?

The purpose of this research study is to compare the effects of metformin and bicalutamide (a type of hormonal therapy that is already approved by the FDA) versus bicalutamide alone on lowering your PSA. PSA is a protein produced by cells of the prostate gland. The blood level of PSA often rises in men with prostate cancer. The study will also evaluate safety of the metformin and bicalutamide when given together.  
It is thought that the combination of drugs used in this study may stop or slow the rising of your PSA and prevent your cancer from coming back or keep it in remission for a longer period of time. Metformin is a medication used to treat diabetes that is widely used as first line therapy for type II diabetes. Metformin is FDA approved, but not for cancer treatment and is being used as an investigational agent in this study. In this study you will receive either metformin combined with bicalutamide or bicalutamide alone. If you are selected to receive bicalutamide, you will not be eligible to receive metformin as part of this study. In addition to the treatment part of this study, the researchers plan to test samples of your tumor and some of your blood. The purpose of this research is to determine whether the presence of certain proteins and genes predict if this drug will be an effective treatment for prostate cancer. Also, in addition to the treatment part of this study, the researchers want to know your view of how your life has been affected by cancer and its treatment. As part of this study you will be asked to complete questionnaires about your quality of life.
Clinical trial: NCT02614859
Section: Withdrawal from Study
Subsections: Can You Stop Being In The Research Study?|Can You Be Removed From This Research 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 drugs can be evaluated by your doctor. Another reason to tell your 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 research study at any time if he/she believes it is in your best interest; if you do not follow the research study rules; or if the research study is stopped.