Clinical trial: NCT03634579
Section: Alternatives
Subsections: Will I Benefit Directly From The Study?|What Are My Other Options?

You may benefit from having your prostate cancer treated with a minimally invasive procedure without having to undergo surgery, radiation, or hormone treatment. You will also benefit from being enrolled in a close follow up program to monitor the response to treatment. This way, if cancer recurrence is found at any time, we will be able to either apply the same laser ablation treatment again if you are still a candidate or refer you to another form of traditional treatment. In addition, your participation may help future patients having this same procedure by establishing the potential benefit of this new treatment method.

The treatment provided by this study is experimental. If you decide not to enter this study, there is care available to you outside of this research study. You may still choose to be on active surveillance or go to surgery or radiotherapy which are the current standard of care treatment options. The study doctor will discuss these with you. You do not have to be in this study to be treated for prostate cancer. Taking part in this study, however, may make you unable to participate in some other research studies, if they exclude people who have taken certain treatments. You should discuss this with the researchers if you have concerns. You may wish to research other study options at websites like clinicaltrials.gov and ResearchMatch.org.
Clinical trial: NCT03634579
Section: Confidentiality
Subsections: Who Owns My Study Information And Samples?|How Will You Protect My Private Information That You Collect In This Study?|Authorization To Use And Disclose Protected Health Information|Phi That Will Be Used/Disclosed:|Purposes For Which Your Phi Will Be Used/Disclosed:|Use And Disclosure Of Your Information That Is Required By Law:|People Who Will Use/Disclose Your Phi:|Other Items You Should **Know About Your Privacy**

If you join this study, you will be donating your study information. You will not receive any compensation if your information are used to make a new product. If you withdraw from the study, data that were already collected may be still be used for this study.

Whenever possible, a study number, rather than your name, will be used on study records. Your name and other identifying information will not appear when we present or publish the study results.  
Study records can be opened by court order. They also may be provided in response to a subpoena or a request for the production of documents.

The privacy of your health information is important to us. We call your health information that identifies you, your "protected health information" or "PHI." To protect your PHI, we will follow federal and state privacy laws, including the Health Insurance Portability and Accountability Act and regulations (HIPAA). We refer to all of these laws as the "Privacy Rules." Here we let you know how we will use and disclose your PHI for the study .

The PHI that we will use or share for the main research study includes:
- Medical information about you including your medical history and present/past medications. - Results of exams, procedures and tests you have before and during the study.  
- Laboratory test results.

We will use and share your PHI for the conduct and oversight of the research study. We will use and share your PHI to provide you with study related treatment and for payment for such treatment. We will also use and share your PHI to conduct normal business operations. We may share your PHI with other people and places that help us conduct or carry out the study, such as laboratories, data management centers, data monitors, contract research organizations, Institutional Review Boards (IRBs) and other study sites. If you leave the study, we may use your PHI to determine your health, vital status or contact information.

We will use and disclose your PHI when we are required to do so by law. This includes laws that require us to report child abuse or abuse of elderly or disabled adults. We will also comply with legal requests or orders that require us to disclose your PHI. These include subpoenas or court orders.

The following people and groups will use and disclose your PHI in connection with the research study:
- The Principal Investigator and the research staff will use and disclose your PHI to conduct the study and give you study related treatment.  
- Emory may use and disclose your PHI to get payment for study related treatment and to run normal business operations.  
- The Principal Investigator and research staff will share your PHI with other people and groups to help conduct the study or to provide oversight for the study.  
- Dr. Sherif Nour is the Sponsor of the study. The Sponsor may use and disclose your PHI to make sure the research is done correctly and to collect and analyze the results of the research. The Sponsor may disclose your PHI to other people and groups like study monitors to help conduct the study or to provide oversight for the study.  
- The research team and the Sponsor may use and disclose your PHI, including disclosure to insurance carriers to administer payment for subject injury.  
- The following people and groups will use your PHI to make sure the research is done correctly and safely:
o Emory offices that are part of the Human Research Participant Protection Program and those that are involved in study administration and billing. These include the Emory IRB,
the Emory Research and Healthcare Compliance Offices, and the Emory Office for Clinical Research.  
o Government agencies that regulate the research including: Food and Drug Administration.  
o Public health agencies.  
o Research monitors and reviewer.  
o Accreditation agencies.  
- Sometimes a Principal Investigator or other researcher moves to a different institution. If this happens, your PHI may be shared with that new institution and their oversight offices. PHI will be shared securely and under a legal agreement to ensure it continues to be used under the terms of this consent and HIPAA authorization.

Not all people and entities are covered by the Privacy Rules. HIPAA only applies to health care providers, health care payers, and health care clearinghouses. If we disclose your information to people who are not covered by the Privacy Rules, including HIPAA, then your information won't be protected by the Privacy Rules. People who do not have to follow the Privacy rules can use or disclose your information with others without your permission if they are allowed to do so by the laws that cover them To maintain the integrity of this research study, you generally will not have access to your PHI related to this research until the study is complete. When the study ends, and at your request, you generally will have access to your PHI that we maintain in a designated record set. A designated record set is data that includes medical information or billing records that your health care providers use to make decisions about you. If it is necessary for your health care, your health information will be provided to your doctor.  
We may remove identifying information from your PHI. Once we do this, the remaining information will not be subject to the Privacy Rules. Information without identifiers may be used or disclosed with other people or organizations for purposes besides this study.
Clinical trial: NCT03634579
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Possible Risks And Discomforts? There May Be Side Effects From The Study Procedures That Are Not Known At This Time.|In Case Of Injury

The most common risks and discomforts expected in this study are: irritation of the urethra, catheter discomfort, mild bleeding in urine or stools (in a previous similar study reported rates were between 8-15 %)
The less common risks and discomforts expected in this study are: infection, Urinary tract obstruction, abnormal erection, and urine or fecal incontinence (losing control of urine and stool). Rare but possible risks include: Blood clots in the pelvic veins It is possible that the researchers will learn something new during the study about the risks of being in it. If this happens, they will tell you about it. Then you can decide if you want to continue to be in this study or not. You may be asked to sign a new consent form that includes the new information if you decide to stay in the study.

If you get ill or injured from being in the study, Emory will help you get medical treatment. Emory has not, however, set aside any money to pay you or to pay for this medical treatment. The only exception is if it is proven that your injury or illness is directly caused by the negligence of an Emory employee. "Negligence" is the failure to follow a standard duty of care. If you become ill or injured from being in this study, your insurer will be billed for your treatment costs. If you do not have insurance, or if your insurer does not pay, then you will have to pay these costs. If you believe you have become ill or injured from this research, you should contact Dr. Sherif Nour at telephone number (404) 778-3164. You should also let any health care provider who treats you know that you are in a research study.
Clinical trial: NCT03634579
Section: Procedures
Subsections: What Will I Be Asked To Do? Before Procedure:|Procedure:

You will be asked to have blood test (about 5 mL, equivalent to a teaspoon full) to determine your pretreatment baseline of your tumor marker (serum PSA level) so we can monitor your disease on follow ups. We will also test the ability of your blood to normally form a clot after puncturing the prostate gland to avoid serious bleeding.

Before coming to the hospital, you will be requested to take oral antibiotics and oral urinary tract pain killers. If you are taking blood thinners, you will be requested to stop them 5 days before the procedure (please check with your treating physician). An overnight fasting for 8 hours is required prior to the procedure. On the morning of the procedure you will have a Fleet enema. When you arrive at the hospital, a catheter will be inserted to protect the urethra. In the procedure room, you will have general anesthesia (you will be totally asleep with no feeling of the surrounding) and will be put to sleep on your belly inside the MRI scanner. After lesion identification, a laser fiber will be inserted into your prostate under MRI guidance, either through your rectum or your buttocks and ablation (the tumor burning procedure) will be monitored using real time temperature maps to ensure appropriate and safe ablation. Afterwards, MRI scan will be done to serve as a baseline for follow up. The catheter will remain for 3 days and will be removed in the radiology department or at your local urologist office if you live far away or if this is your preference. You are expected to participate in a long-term follow up process. Follow ups in person clinic visits will be scheduled at 3 weeks, 3 months, 6 months, one year and two years. Each follow up time point is calculated from the previous visit, not from procedure date. In each visit, you will have a MRI, serum PSA, fill forms to assess your urinary continence and erectile function, and if applicable, discuss an MRI guided biopsy, which would be done on a different date.
Clinical trial: NCT03634579
Section: Purpose of Research
Subsections: What Is The Purpose Of This Study? Background:|Purpose:

Prostate cancer is the most common cancer (other than skin cancer) in American men, with 1 in 7 men being diagnosed with this disease during his lifetime. The American Cancer Society expected the number of new prostate cancer cases in 2017 to be 161,360. With 26,730 expected deaths from this disease during the same year, prostate cancer is the second deadliest cancer in American men after lung cancer. Prostate cancer has different levels of grades, ranging from a very low-risk process to an aggressive high-risk potentially fatal disease. The possibility that a "true" low-risk prostate cancer advances to metastatic disease is very small. Much more likely, a high-risk cancer has been present and undetected from the beginning. Over the past years, doctors have been concerned that patients with true low-risk prostate cancer are being over treated. Many studies showed that there is no benefit from aggressive treatment of the whole prostate gland, such as with surgery or radiation, in patients with low-risk prostate cancer. A large study showed that 55% of 24,405 patients treated for low-risk prostate cancer in the United States have received unnecessary aggressive treatment. The problem with aggressive treatment is that too many patients end up with serious lifechanging complications such as losing control on their urination or defecation or losing the ability for erection.  
These patients could have a better quality of life with less aggressive treatment while receiving no less care for their cancers.  
Another way to handle low-risk prostate cancer and avoid these complications is to choose to just watch it
(also called active surveillance). The problem with this choice is that it is difficult for some people to have a normal daily life when they know they have untreated cancer in their body. It also may be too late for treatment if cancer spreads while being watched.  
Because it is difficult to choose between going for aggressive treatment with high risk for complications and choosing not treat at all, doctors are now experimenting a new treatment where they only destroy the area of cancer and leave the rest of the prostate unharmed. They want to see if this method will have less complications than aggressive whole gland treatments (such as surgery or radiation). They also want to see if cancer will be really well-controlled with this treatment.

The purpose of this study is to evaluate the use of laser fibers to burn localized prostate cancers under MRI guidance. We need to know how effective it is in killing the tumor and how it may affect urinary and rectal continence and erectile function. We will enroll 20 patients with localized prostate cancer visible on MRI.  
Tumors will be burnt using an FDA-approved laser device (Visualase, Medtronic, USA). Patients will be followed up for 2 years to see if tumor is completely treated and to see the effect of treatment on urinary and rectal continence and erectile function.
Clinical trial: NCT03634579
Section: Voluntary Participation
Subsections: Do I Have To Do This?|Authorization To Use Phi Is Required To Participate:

No. Being in this study is entirely your choice. If you decide to join this study, you can change your mind later on and withdraw from the research study.  
Taking part in a study is separate from medical care. The decision to join or not join the research study will not affect your status as a patient.

By signing this form, you give us permission to use and share your PHI as described in this document. You do not have to sign this form to authorize the use and disclosure of your PHI. If you do not sign this form, then you may not participate in the research study or receive research-related treatment. You may still receive non-research related treatment.
Clinical trial: NCT03634579
Section: Withdrawal from Study
Subsections: Withdrawal From The Study You Have The Right To Leave A Study At Any Time Without Penalty.|Revoking Your Authorization

For your safety, however, you should consider the study doctor's advice about how to go off the study treatment. If you leave the study before the final planned study visit, the researchers may ask you to have some of the final steps done.  
The researchers also have the right to stop your participation in this study without your consent for any reason, especially if they believe it is in your best interest or if you were to object to any future changes that may be made in the study plan.

If you sign this form, at any time later you may revoke (take back) your permission to use your information. If you want to do this, you must contact the study team at: sherif.nour@emoryhealthcare.org At that point, the researchers would not collect any more of your PHI. But they may use or disclose the information you already gave them so they can follow the law, protect your safety, or make sure that the study was done properly and the data is correct. If you revoke your authorization you will not be able to stay in the study.