Clinical trial: NCT02681614
Section: Confidentiality
Subsections: 9. Privacy And Confidentiality Authorization To Use Or Disclose (Release) Health Information That Identifies You For A Research Study

If you volunteer to participate in this research, your protected health information (PHI) that identifies you will be used or disclosed to Bryan Traughber, MD and the research study staff at University Hospitals 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 such as the University Hospitals Institutional Review board. Your PHI may also be used by and/or disclosed (released) to:  
Philips Medical, its study monitors and representatives The Food and Drug Administration; The Department of Health and Human Services; The National Cancer Institute (NCI); Other Institutional Review Boards; Data Safety and Monitoring Boards; Case Comprehensive Cancer Center
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 disclosures at any time by writing to: Bryan Traughber, MD Case Comprehensive Cancer Center University Hospitals Cleveland Medical Center 11100 Euclid Ave. Cleveland, OH 44106 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. University Hospitals will not use your information collected in this study for another research purpose without your written permission; unless the University Hospitals Institutional Review Board 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: NCT02681614
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 4. Risks|Risks Of The Uronav Guided Biopsy Procedure:|Potential Risk Or Discomfort From Procedures: Reproductive Risks|8. Research-Related Injury

As with any experimental procedure, there may be adverse events or side effects that are currently unknown and some of these unknown risks could be permanent, severe, or life-threatening. Your health care team may give you medication to help lessen side effects. Many side effects go away soon after you undergo the Uronav guided biopsy. In some cases, side effects can be serious, long lasting, or may never go away. As with any investigational procedure (procedures being done for experimental purposes), there may be adverse events or side effects that are currently unknown.

A transperineal biopsy is a biopsy procedure in which a sample of tissue is removed from the prostate for examination under the microscope. The sample is removed with a thin needle that is inserted through the skin between the scrotum and rectum and into the prostate. The risk for prostate edema (swollen prostate) and urinary obstruction (blocked urine) may be increased due to the extra transperineal needle placement during the biopsy. If this happens, you will be asked to maintain a Foley Catheter overnight to allowed edema to resolve, and to avoid any further obstruction the following day. A Foley catheter is a flexible tube passed through the urethra and into the bladder to drain urine. Your doctor will give you further instructions if this is necessary. Other expected risks include infection requiring additional antibiotic treatment beyond the standard postoperative antibiotic, and readmission to the hospital for pain. The Philips Medical's Uronav device poses no significant risk, however, any unanticipated complications or infections will be recorded by study staff.

Men who are able to father children should use adequate contraception. The Uronav system, will be used in your guided biopsy free of charge, provided by Philips Medical, while you are participating in this study. Neither you nor your insurance provider will be responsible for the costs of any research-only tests or procedures. IRB NUMBER: 11-15-13C  
Avoiding sexual activity is the only certain method to prevent pregnancy. However, if you choose to be sexually active, you should use an appropriate "double barrier" method of birth control: female use of a diaphragm, intrauterine device (IUD), contraceptive sponge, prescribed "birth control" pills, injections, or implants, in addition to male use of a condom. You should use contraceptives during treatment. If you choose to be sexually active during this study, you understand that even with the use of these birth control measures pregnancy could still result. If your female sexual partner becomes pregnant while you are taking part in this study, you must notify one of the study doctors so that management of the pregnancy can be discussed.

If you believe that you are injured as a result of the research procedures being performed, please immediately contact the study doctor. If injury occurs as a result of your involvement in this research, medical treatment is available from University Hospitals or another medical facility but you/your medical insurance will be responsible for the cost of this treatment. A research injury is an injury that happens as a result of taking part in this research study. If you are injured by a medical treatment or procedure that you would have received even if you weren't in the study, that is not considered a "research injury". There are no plans for payment of medical expenses or other payments, including lost wages, for any research related injury. To help avoid injury, it is very important to follow all study directions.  
Further information about research-related injuries is available by contacting the University Hospitals Cleveland Medical Center's Research Subject Rights phone line at (216) 983-4979.
Clinical trial: NCT02681614
Section: Procedures
Subsections: 3. Study Procedures Before You Begin This Study:|During The Study:|Biopsy:

You will need to have certain exams, tests or procedures (called "screening tests") to help your study doctor determine if you are eligible for this study. This is called the pretreatment "screening" period. You will be asked to sign this consent form before beginning any screening tests. Some of 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. If they were done too long ago they may need to be repeated. Your doctor/study team will discuss which, if any, tests need to be repeated.

You will receive standard treatment during your involvement in this study. Your study participation will total 5 visits.  
Screening:
You will be asked to sign this consent form, after you have had time to take it home and read it.  
Your vital signs (blood pressure, pulse, temperature, and respiration) will be recorded You will be asked about your medical and cancer history.  
You will be asked what medications you are currently taking. This includes over-thecounter medications, vitamins, herbal supplements, and illegal substances.  
You will be asked about how well you can perform daily tasks.

You will undergo an Uronav guided biopsy. This procedure is standard but involves a research related device. The tissue from the biopsy will be used to research the main purpose of the study as described on page 1 of this consent form. Your tissue will only be used for this purpose and will not be stored for future testing.  
o All biopsies will be completed per standard of care recommendations.  
Visit 3 about 2 weeks after biopsy (this may be a nurse phone call):
You will be asked about any side effects you may be having. This includes side effects
from the Uronav guided biopsy, which is a research related device.  
You will be asked about how well you can perform daily tasks  
Visit 4 (about 30 days after biopsy):
Your vital signs (blood pressure, pulse, temperature, and respiration) will be recorded You will be asked about your medical and cancer history.  
You will be asked what medications you are currently taking. This includes over-thecounter medications, vitamins, herbal supplements, and illegal substances.  
You will be asked about how well you can perform daily tasks. You will be asked about any side effects you may be having. This includes side effects from the Uronav guided biopsy, which is a research related device.  
Visit 5 (about 3 months after biopsy):
Your vital signs (blood pressure, pulse, temperature, and respiration) will be recorded You will be asked about your medical and cancer history.  
You will be asked what medications you are currently taking. This includes over-thecounter medications, vitamins, herbal supplements, and illegal substances.  
You will be asked about how well you can perform daily tasks. You will be asked about any side effects you may be having. This includes side effects from the Uronav guided biopsy, which is a research related device.
Clinical trial: NCT02681614
Section: Purpose of Research
Subsections: 2. Purpose

You are being asked to take part in a clinical research study because you have been diagnosed with low to moderate risk prostate cancer, and you will be having Brachytherapy treatment. The main purpose of this study is to test similarities and differences of biopsy tissue structures and the findings from the intraprostatic MRI (internally guided MRI). As part of standard MRI guided biopsy procedure, virtual markers are placed on the image for the MRI and or ultrasound to help plan the procedure. These markers are called fiducial markers. As part of this research study, the Uronav device will be used to help position those markers and track the biopsy location in your prostate before your routine prostate brachytherapy. This will be used to evaluate the dose of radiation to the positive biopsy locations in addition to the whole prostate gland. The Uronav device has been determined by Food and Drug Administration (FDA) to be similar enough to other devices that are already FDA approved for use in patients with prostate cancer, so it is not considered investigational. Your radiation therapy treatment will be planned by your treating physician and will not be experimental or part of this research study. This study is also collecting information on the doses of radiation in your brachytherapy, the amount of space in your body it covers, and how close the radiation is to your organs. About 6 subjects (men who are at least 18 years of age) will take part in this study at University Hospitals.
Clinical trial: NCT02681614
Section: Voluntary Participation
Subsections: 10. Voluntary Participation

Your participation in this research study is voluntary. Choosing not to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risks or benefits associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.