Clinical trial: NCT01377753
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:  
x Getting treatment or care for your cancer without being in a study; this may include observation to see if your tumors get larger over time (called active surveillance), or it may include treatment of the entire prostate gland, with surgery or radiation therapy.  
x Taking part in another study
Please talk to your doctor about these and other options.
Clinical trial: NCT01377753
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:  
x You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
x There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs even if they are not covered by your insurance company.  
x Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
x Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Clinical trial: NCT01377753
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect **From Being In This Study?**|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

MRI guided laser therapy: This procedure has been used to treat other types of tumors, including tumors of the brain, liver, bone and thyroid. There has not been a lot of experience using this exact procedure to treat tumors in the prostate so there are risks that we cannot predict. The risks listed below are primarily possible risks as they have not been seen in studies using this procedure in humans. As with any invasive procedure potential risks include bleeding, infection, and pain. In addition due to the use of the catheter there is the risk of urinary tract problems, including irritation during voiding or a feeling of urgency and frequency, blood in the urine, difficulty urinating. The use of thermal laser may damage tissue or organs next to the tumor, such as possible damage to the rectal wall, bladder wall, or causing erectile dysfunction or blood in the sperm. Putting in the laser apparatus (Visualase applicator) will be done under sterile conditions to reduce the chance of infection and you will receive antibiotics according to the American Urologic Association recommendations. No serious side effects or complications have been observed in any patients treated to-date with thermal ablation using this system.

The aim of this study is to see if this experimental procedure is safe and if it will eliminate your prostate tumor. We hope that you will get personal medical benefit from taking part in this study, but we cannot be certain. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 11-C-0158 CONTINUATION: page 6 of 9 pages much information about the procedure's effect on your type of cancer, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.
Clinical trial: NCT01377753
Section: Procedures
Subsections: Description Of Research Study What Will Happen If You Take Part In This Research Study?

Before you begin the study You will undergo some standard tests to make sure you are eligible to participate in this study, including a physical exam, laboratory tests, a standard MRI and a metastatic work up if indicated by your condition, to make sure your cancer has not spread. These tests are part of standard cancer care and may be done even if you are not participating in this study. You will also undergo a standard 12 core biopsy of the prostate. This means that the biopsy will include needle samples from 12 locations in the prostate. The selection of these locations will be guided by MR imaging and ultrasound, which is obtained through the coil in your rectum. During the study If you are eligible to participate, we will schedule you for the MRI guided laser therapy.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 11-C-0158 CONTINUATION: page 3 of 9 pages First we will ask you to complete two questionnaires about the effects of your cancer on your health and well-being. You may need to have a scan or MRI repeated, depending on when the eligibility scan was done. You will be admitted to the Clinical Center Hospital and taken to the MRI unit. You will be given general anesthesia after which a cooling catheter (plastic tube) will be put in your bladder. The MRI is used to help your doctor guide the laser applicator (similar to a biopsy needle) directly to your tumor. The doctor will be using the MRI while he/she applies the energy from the laser, to control how much energy is delivered and how much tissue is destroyed. This allows the doctor to protect the organs next to your tumor, such as the urethra or nerves. The entire procedure usually takes from 1.5 to 3 hours.  
After the doctor delivers the laser treatment, the cooling catheter will be removed and 'Foleytype' catheter will be put in your urethra to keep your bladder emptied. This catheter will be left in your bladder for 1 to 7 days. The doctor will also give you medicines to prevent any bladder spasms. You will also be asked to take an antibiotic before the treatment, which may be continued the day after the treatment. The day after the procedure, you will have a physical exam and blood tests, including an evaluation of your PSA level. You will be discharged from the hospital, after 1-2 days, when you are feeling up to it, and be asked to return to have your catheter removed (if not removed before you leave the hospital). You will be given an antibiotic to take the day before, day of and the day after the catheter is removed. When you are finished undergoing the treatment procedure We will watch you closely after the procedure and ask you to return to the NCI Clinic 3, 6, 12, 18, 24, and 36 months after the procedure. At each visit you will have a physical exam and laboratory tests, including your PSA level. In addition, we will ask you to fill out the two questionnaires you completed before your procedure again, so we can see the effects of the procedure on your health and well-being. You will also undergo an MRI (6, 12, 24, and 36 months) or other scans if needed, and a prostate biopsy to see if there is any tumor every 12 months for the first two years; the biopsy at the third year visit is optional. Study Chart The chart below gives a summary of events for your participation in this study.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 11-C-0158 CONTINUATION: page 4 of 9 pages  
| Day                                                                                             | What to do and what will happen to you                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Before the  MRI guided  laser therapy                                                           | Provide a history of how you feel and undergo a physical examination by the  research team's Health Care Provider in Urology (OP3) Clinic  Get routine blood tests, including PSA  An MRI and a prostate biopsy will be done to evaluate your tumor  The research team will ask you to complete 2 questionnaires                                                                                                                                                                                                                                                         |
| Day before  the MRI  guided laser  therapy                                                      | Start antibiotics as directed                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| Day of the  MRI guided  laser therapy                                                           | You will be taken to special MRI operating room and be given general  anesthesia  The surgeon will use the MRI to guide the placement of the laser device and the  tumor will be heated with laser thermal energy  After completing the procedure, a catheter will be left in your bladder  You will recover in the recovery room and then taken to the Surgery Unit where  the nurses and doctors will watch you closely for any ill-effects, such as  bleeding, infection. You will be given medicine to make you comfortable and  an antibiotic to prevent infection. |
| 1st day after  the MRI  guided laser  therapy                                                   | Physical examination, including a digital rectal exam.  Get routine blood tests, including PSA  An MRI with an endorectal coil will be done  You will most likely be allowed to go home about 24 hours later.                                                                                                                                                                                                                                                                                                                                                            |
| Between 1-7  days after the  procedure                                                          | You will be given an appointment to return to NIH to have the bladder catheter  removed. You will be asked to take an antibiotic the day before, the day of and  the day after the catheter removal.                                                                                                                                                                                                                                                                                                                                                                     |
| Follow up  visits: 3,  6,12, 18 and  24 months,  then annually  thereafter for  3 years (total) | NIH visit  Have a history taken of how you feel, physical examination by a Health Care  Provider in the Urology (OP3) Clinic  Blood drawn for routine lab tests  Complete the 2 questionnaires  MRI and prostate biopsy to test for disease at selected visits as described above.                                                                                                                                                                                                                                                                                       |
| PATIENT IDENTIFICATION                                                                          | CONTINUATION SHEET for either:  NIH-2514-1 (07-09)  NIH-2514-2 (10-84)  P.A.: 09-25-0099  File in Section 4: Protocol Consent                                                                                                                                                                                                                                                                                                                                                                                                                                            |  
STUDY NUMBER: 11-C-0158 CONTINUATION: page 5 of 9 pages
Clinical trial: NCT01377753
Section: Purpose of Research
Subsections: Background Information What Is A Research Study?|Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?

A research study is a carefully supervised study that is done in humans to answer specific questions about a medicine or a procedure. Research studies are used to test whether a study drug (medicine) or procedure is safe and effective in humans.  
PATIENT IDENTIFICATION CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH **STUDY**  
  
- Adult Patient or - Parent, for Minor Patient NIH-2514-1 (07-09) P.A.: 09-25-0099 File in Section 4: Protocol Consent (1)
STUDY NUMBER: 11-C-0158 CONTINUATION: page 2 of 9 pages

This study is being done to test the safety and feasibility of treating prostate tumors with laser heated therapy guided by an imaging technique, magnetic resonance imaging (MRI) and an endorectal probe placed in the rectum. These images will allow the doctors see the prostate tumor and accurately target them for laser treatment. The laser treatment, called 'laser-induced interstitial thermal therapy' or LITT is a novel way to direct extreme heat to a small area of tissue where the tumor is located, to destroy the tumor tissue without damaging nearby normal organs or tissue. This procedure is being tested because it has not been used for treating many people with prostate cancer, so we do not yet know all the effects (good and bad) of using this system, or whether it can destroy tumor cells permanently. This system has been accepted by the US Food and Drug Administration (FDA) for this use.

You are being asked to take part in this study because you have been diagnosed with biopsyproven prostate cancer that can be seen with an MRI, and has not spread to other parts of your body.
Clinical trial: NCT01377753
Section: Withdrawal from Study
Subsections: Stopping Participation

Your doctor may decide to stop your therapy for the following reasons:
x if he/she believes that it is in your best interest x if your disease comes back or spreads after the procedure x if new information shows that another treatment would be better for you x you have completed the study requirements  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
  
STUDY NUMBER: 11-C-0158 CONTINUATION: page 7 of 9 pages In each 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.