Clinical trial: NCT02770391
Section: Confidentiality
Subsections: Will My Medical Information Be Kept Private?|Authorization To Use Or Disclose (Release) Health Information That Identifies You For A Research Study

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:
The National Cancer Institute (NCI) and other government agencies, like the Food and Drug
.  
Administration (FDA), involved in keeping research safe for people Janssen Scientific Affairs, LLC
.

If you volunteer to participate in this research, your protected health information (PHI) that identifies you will be used or disclosed to Moshe Ornstein, MD, MA and the research staff at Cleveland Clinic for the purposes of this research and to Case Western Reserve University for administration.  
The PHI that we may use or disclose (release) for this research may include your name, address, phone number, date of birth, Social Security number, information from your medical record, lab tests, or certain information relating to your health or  condition.  
Some of the tests and procedures done solely for this research study may also be placed in your medical record so other doctors know you are in this study. Upon completion of the study, you may have access to the research information that is contained in your medical record.  
In addition to the investigators and research staff listed above, your PHI may be looked at by other groups involved with the study sue~ as the Cleveland Clinic Institutional Review Board and the Case Comprehensive Cancer Center Protocol Review and Monitoring Committee. Your PHI
may also be used by and/or disclosed (released) to:  
The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for People;
.  
The Department of Health and Human Services;
.  
The National Cancer Institute (NCI); Other Institutional Review Boards;
.  
Data Safety and Monitoring Boards;
.  
Janssen Scientific Affairs, LLC will receive your safety-related information, but it will not
.  
include PHI.
Once your personal health information is released it may be re-disclosed and no longer protected by privacy laws.  
Your research information may be used and disclosed indefinitely, but you may stop these uses and disclosure-s at any time by writing to:
Moshe Ornstein, MD, MA
9500 Euclid Ave. CA-60 Cleveland, OH 44195 Your participation in the research will stop, but any information previously recorded about you cannot be removed from the records and will continue to be used as part of this research. Also, information already disclosed outside the Cleveland Clinic cannot be retrieved. This will not affect your rights to treatment or benefits outside the research study.  
The Cleveland Clinic will not use your information collected in this study for another research purpose without your written permission; unless the Cleveland Clinic Institutional Review Board
(RB) assures your privacy and confidentiality is protected. The IRB is a committee whose job it is to protect the safety and welfare of research subjects.  
By signing this informed consent form, you are authorizing such access to your research and medical record information. If you choose not to sign this consent form, you will not be able to participate in this research study.  
This Authorization does not have an expiration date.
Clinical trial: NCT02770391
Section: Duration of Study Involvement
Subsections: How Long Will I Be In The Study?

You will be asked to take Apalutamide for about 28 days before your prostate surgery. You also will receive a single one-month intramuscular injection (Buttock region) of leuprolide acetate.  
Your last dose of Apalutamide will be taken on the day before your surgery. When you come for your post-surgery follow up visit you will have your final evaluation before finishing your participation in this study.
Clinical trial: NCT02770391
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can I Expect From Being In The Study?|Loss Of Personally Identifiable Genetic Material:

The possible discomforts, side effects, and risks from apalutamide are not all known.  Some side effects may be serious and require treatment or additional testing.  This section describes common side effects from apalutamide.  
There may be risks with apalutamide that are not yet known.  You will be monitored carefully for side effects. During the study, the sponsor or study doctor may learn new facts about apalutamide. Your study doctor will inform you of any important new information about apalutamide.  It is possible that this new information might make you change your mind about being in the study.  
Side effects may be mild, moderate, serious or even life-threatening.  If you experience any side effects, your doctor may give you medicines to help lessen the side effects. Some side effects may go away soon after you stop taking the study medicine.  Other side effects can be serious or long-lasting.  
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Your prostate tissue and DNA will be stored in a secured area with access limited to the research staff and personnel assigned to tissue and DNA storage laboratories. However, it is possible that tumor tissue, DNA, or information regarding either will be lost.
Clinical trial: NCT02770391
Section: Procedures
Subsections: What Will Happen If I Take Part In This Research Study?

If you decide to take part of this study, the following will occur:  
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Clinical trial: NCT02770391
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?

Yes. You can decide to stop/ withdraw from the study at any time without ramifications. Tell your 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 Apalutamide 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 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.