Clinical trial: NCT03478904
Section: Alternatives
Subsections: Alternative Approaches Or Treatments

What other choices do I have if I do not take part in this study? Instead of being in this study, you have these options:
Choose to not participate Take part in another study Please talk to your doctor about these and other options.
Clinical trial: NCT03478904
Section: Confidentiality
Subsections: Confidentiality Protections Provided In This Study Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality|Privacy Act

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. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
The NIH and other government agencies, like the Food and Drug Administration (FDA),
which are involved in keeping research safe for people.  
National Institutes of Health Intramural Institutional Review Board When results of an NIH research study are reported in medical journals or at scientific meetings, the people who take part are not named and identified. In most cases, the NIH will not release any information about your research involvement without your written permission. However, if you sign a release of information form, for example, for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens or data. You should be aware that there is a slight possibility that someone could figure out the information is about you. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances. NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court. The Certificate does not protect your information when it:  
1. is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or 2. is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
3. is for other research; 4. is disclosed with your consent.
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.

The Federal Privacy Act generally protects the confidentiality of your NIH medical records we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your medical record without your permission, for example, if it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.
Clinical trial: NCT03478904
Section: Duration of Study Involvement
Subsections: Before You Begin The Study

Certain criteria have been established to ensure that you are a medically appropriate candidate for this trial. These criteria also make sure that the results of this study can be used to help make decisions about treating other patients. Before beginning the study, you will need to have tests and/or procedures to help your doctor decide whether you can take part in the study. This is called screening. Most of the exams, tests, and procedures you will have are part of regular cancer care. However, there are some extra tests that you will need to have if you take part in this study. If you have had some of them recently, they may not need to be repeated. These tests include:
Review of your previously collected tissue or a laboratory report to confirm your diagnosis History and physical evaluation including vital signs Routine blood tests ECG
Testosterone and prostate-specific antigen (PSA) levels ECOG performance status You will be removed from the study if these tests indicate that you may not be a suitable candidate.
Clinical trial: NCT03478904
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Birth Control|Risks Or Discomforts Of Participation|Other Risks Related To Research Tests|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

Your study doctor will discuss the risks to unborn children for the drugs used in this study. The effects of the study drugs, if any, on unborn children are unknown. If your partner is capable of becoming pregnant and you wish to participate in this study, then you must use a medically acceptable method of birth control while you are receiving study medications and for 3 months after your last dose of study medication. If your partner becomes pregnant during the course of treatment, you must inform your doctor immediately. Your doctor will ensure that you and your partner receive information about options available to you in relation to pregnancy and that you and your partner are fully supported in whichever option you chose. Effective forms of birth control for you and your partner include:
- abstinence intrauterine device (IUD)
- hormonal [birth control pills, injections, or implants]
- tubal ligation
- vasectomy

Possible side effects of enzalutamide:  
Likely:
Ankle swelling.  
Fatigue Headache Hot flashes Diarrhea Low blood counts Back pain Upper respiratory tract infection
Less Likely:
High blood pressure Dizziness, anxiety Dry skin  
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Blood in urine Jaundice Weakness of muscles Rare but Serious:
Seizures
*Posterior reversible encephalopathy syndrome (PRES)
*There have been rare reports of posterior reversible encephalopathy syndrome (PRES), a rare, reversible condition involving the brain, in patients treated with enzalutamide. If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor right away. Your doctor will stop enzalutamide if you develop PRES.

The study treatment may involve risks to you that are currently unknown. Your cancer may not get better or may become worse while you are in this study. Blood draws: There may be some side effects associated with the procedures for drawing blood in this study, but the person drawing your blood will attempt to minimize this discomfort. Side effects include pain and bruising in the area where the needle is inserted, lightheadedness, and rarely, fainting. When large amounts of blood are collected, low red blood cell count (anemia) is a risk.

The aim of this study is to determine whether your body handles the experimental liquid formulation of enzalutamide similarly to the standard gel capsule, and to evaluate if it is safe and tolerable. You will not receive personal, medical benefit from taking part in this study. However, the knowledge gained from this study may help others in the future who have cancer
Clinical trial: NCT03478904
Section: Procedures
Subsections: During The Study

If you are eligible for the study, some of the tests that were performed for screening may need to be repeated depending on when they were done. Your study doctor will let you know. In addition, you will have a routine urine test. You will be randomized (selected by a procedure similar to a flip of a coin) to receive treatment of either standard capsule enzalutamide treatment (Arm A) or the test liquid formulation enzalutamide (Arm B). This is period 1 of the study. In period 2 of the study, 42 days after you have received your first dose of enzalutamide, you will switch arms and receive a second dose. That is, if you were initially assigned to take capsules in period 1, you will take the liquid in period 2. If you were initially assigned to take the liquid during period 1, you will take the capsules in period 2. On the days (Day 1 of each period) you receive enzalutamide, you will be admitted as an inpatient to the NIH Clinical Center and will be asked to stay for about 24-36 hours. After receiving  
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enzalutamide, we will sample your blood periodically over the next 24 hours. You will be required to avoid eating or drinking for 2 hours before taking the enzalutamide and for 2 hours after taking the enzalutamide. You may resume your normal eating and drinking patterns 2 hours after taking the enzalutamide. On the day you take the liquid formulation, you will be asked to fill out a questionnaire, it will take 10 minutes to complete. At the end of each study period, we will repeat blood and urine tests, history, physical exam as well as the ECG. You will return to the Clinical Center on Day 3, Day 8 and Day 42 of each period for additional blood draws. For these visits you will be at the Clinical Center as an outpatient for about 4 hours.
Clinical trial: NCT03478904
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?

Enzalutamide is a modern hormonal therapy that is approved by the FDA for the treatment of metastatic prostate cancer. Unfortunately, the current 4 pills required to deliver the desired 160mg treatment causes problems for patients. Due to the number of capsules necessary for the current enzalutamide therapy, it can be difficult for cancer patients that already have multiple drugs to take. Additionally, some patients may have difficulty with swallowing, therefore an alternate method of oral administration is necessary. For these reasons, this study will test the new way to give enzalutamide by mouth using a test formulation of liquid enzalutamide removed from the standard gelatin capsules compared to  
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standard 4 gelatin capsules of enzalutamide to find out whether they are handled by the body in the same way.

Because you have been diagnosed with prostate cancer, you are invited to take part in this clinical research. HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? Up to 14 men with prostate cancer will be enrolled in this study. DESCRIPTION OF RESEARCH STUDY What will happen if you take part in this research study?
Clinical trial: NCT03478904
Section: Voluntary Participation
Subsections: It Is Your Choice To Take Part In The Study

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.
Clinical trial: NCT03478904
Section: Withdrawal from Study
Subsections: Stopping Therapy

Your doctor may decide to stop your therapy for the following reasons:
if he/she believes that it is in your best interest if you have side effects from the treatment that your doctor thinks are too severe In this case, you will be informed of the reason therapy is being stopped. You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot be recalled and destroyed.