Clinical trial: NCT02163317
Section: Alternatives
Subsections: 6. Alternatives To Participation

If you do not wish to take part in this research study, your study doctor will discuss alternate treatment options with you, including their benefits and risks. These may include:
Getting treatment or care for your cancer without being in a study.  
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Taking part in other investigational studies with if they are available.  
  
Project Title: CASE 11813: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer Principal Investigator: Elisha Fredman, MD
Sponsor: Case Comprehensive Cancer Center through an Elekta SBRT Research Grant Talk to your study doctor about each of these choices before you decide if you will take part in this study. If you decide not to participate, withdraw your participation after starting the study, or are taken off the study, your study doctor will discuss all other treatment options with you.
Clinical trial: NCT02163317
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 Elisha Fredman, 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 and the Case Comprehensive Cancer Center Protocol Review and Monitoring Committee.  Your PHI may also be used by and/or disclosed (released) to:
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Case Comprehensive Cancer Center, its study monitors and representatives Elekta SBRT Research Grant Program Philips Medical Systems Innovation Center Grant Funding Program The Food and Drug Administration; The Department of Health and Human Services; The National Cancer Institute (NCI);
Other Institutional Review Boards;  
  
Project Title: CASE 11813: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer Principal Investigator: Elisha Fredman, MD
Sponsor: Case Comprehensive Cancer Center through an Elekta SBRT Research Grant
.  
Data Safety and Monitoring Boards; 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:
Elisha Fredman, 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.  Also, information already disclosed outside University Hospitals cannot be retrieved.  This will not affect your rights to treatment or benefits outside the research study.  
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: NCT02163317
Section: Duration of Study Involvement
Subsections: Screening Biopsy And Fiducial Placement - Visit #2 (This Visit Should Take About 2 ½ Hours)|On Study Mri And Ct Scans– Visit #3  (This Visit Should Take About  2 Hours) Ct Pelvic Ct  To Help Plan Your Radiation Treatment .|How Long Will I Be In The Study?|Follow Up, Every 3 Months For Up To 24 Months - Visits #8 - #16 A Physical Examination, Including Vital Signs (Blood Pressure, Pulse, And Temperature), •

A physical examination, including vital signs (blood pressure, pulse, and temperature),
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height, and weight will be recorded You will be asked about any medications you might be currently taking.  It's important
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that you let your doctor know about all medications you are taking. This includes medications that are by prescription, over the counter, vitamins/nutritional supplements herbal products, and hormonal therapy.  
You will be asked how well you are able to do your normal activities (this is called
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"Performance Status")
Some patients may have a hydrogel spacer placed to spare the rectum during radiation
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treatment as standard of care.  
Fiducial markers (small metal markers about the size of a grain of rice) will be placed
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within the prostate to guide daily set up during your three SBRT treatments This procedure uses transrectal ultrasound imaging in the outpatient surgery o center with sedation to place small markers During this procedure additional biopsy samples may be acquired if you have not had a targeted biopsy prior to fiducial placement just prior to placing the marker.  
We will use MRI images to guide the biopsy and marker to the area of the prostate that appears to have cancer on imaging. We will also sample other areas of the prostate during this procedure to check the prostate for the presence of  
  
Project Title: CASE 11813: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer Principal Investigator: Elisha Fredman, MD
Sponsor: Case Comprehensive Cancer Center through an Elekta SBRT Research Grant cancer that is not shown on imaging.  
Should additional cancer be found during this investigational biopsy
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procedure we will advise you and refer you to consultation for evaluation of other treatment options off study, and you will be withdrawn from this study.

o A CT scan uses a computer that takes data from several X-ray images of structures inside your body. This will help the doctors plan your radiation treatment.  
Blood Draw, approximately 2 teaspoons of blood will be drawn to make sure that you can  
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•
also have an MRI.  
Pelvic MRI
SBRT \#1– visit \#4 (This visit should take about 1 ½ hours)
Radiation therapy treatment
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SBRT \#2– visit \#5 (These visits should take about 1 ½ hours)
Radiation therapy treatment
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MRI– visit \#6 (This visit should take about 1 hour)
Pelvic MRI with contrast unless contraindicated
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SBRT \#3– visit \#7 (These visits should take about 1 hour)
You will be asked about any side effects you may or may not be having (this may be
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completed by telephone call within 7 days of this visit) Radiation therapy treatment

You will receive study treatment and follow up until any of the following happen:
your doctor has determined that your cancer has progressed,
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the study treatment causes symptoms prompting you to stop participating the completion or termination of the study.  
  
Project Title: CASE 11813: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer Principal Investigator: Elisha Fredman, MD
Sponsor: Case Comprehensive Cancer Center through an Elekta SBRT Research Grant  
severe side effects occur, you or your physician wishes to discontinue treatment, or
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the study Sponsor finds it necessary to limit or end this study.  
•
After you are finished with the study treatment, the study doctor will ask you to visit the office for a treatment completion visit described below within 30 days after your last radiation treatment (RT).

and weight will be recorded
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You will be asked about any medications you might be currently taking.  It's important that you let your doctor know about all medications you are taking. This includes medications that are by prescription, over the counter, vitamins/nutritional supplements herbal products, and hormonal therapy.  
You will be asked how well you are able to do your normal activities You will be asked to complete questionnaires about your quality of life You will be asked about any side effects you may or may not be having
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Clinical trial: NCT02163317
Section: Participant Responsibilities
Subsections: Your Responsibilities:

During this study, you should call your study doctor immediately if you have any side effects in between your treatment days while on this study. You may also be hospitalized if you have serious side effects.
Clinical trial: NCT02163317
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 4. Risks|Risks Of Stereotactic Body Radiation Therapy (Sbrt)|Potential Risk Or Discomfort From Procedures|Reproductive Risks

High dose radiation can have both short term and long term side effects. 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 medicines to help lessen side effects. Many side effects go away soon after you finish treatments. 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.  
During your participation in this study, you should not receive any other treatment for your cancer (this includes any chemotherapy, radiation, surgery, or any other agents used to reduce or eliminate your tumors).  If your study doctor decides that one of these options would be better for you, you will be withdrawn from the study.

All patients will be seen by their Radiation Oncologist during radiation therapy. Any observations regarding radiation reactions will be recorded and should include attention to the following potential side effects:
Small bowel or rectal irritation which includes symptoms like;
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stomach muscle cramping o diarrhea o rectal urgency, the feeling like you need to defecate suddenly and intensely o swelling of the muscles and lining of the rectum o passage of bright red, bloody stools o Bladder complications such as; urinary frequency/urgency o very painful urination o blood in the urine o urinary tract infection, also called a bladder infection, which can lead to painful o urination incontinence which is involuntary urination or bowel movements Radiation dermatitis, which is swelling and redness of the area receiving the radiation therapy.
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.  
  
Project Title: CASE 11813: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer Principal Investigator: Elisha Fredman, MD
Sponsor: Case Comprehensive Cancer Center through an Elekta SBRT Research Grant

You may have a number of CT scans, nuclear scans, and MRI scans that are part of the regular care for this condition, whether or not you participate in this research. These imaging procedures will not add to the risk of the research. However, concerns about the overall radiation exposure or MRI safety issues should be discussed with a study doctor.

We also advise that your female sexual partner not become pregnant while involved in this study.  
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, and for six months after you stop 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. Should your sexual partner become pregnant during the course of therapy you are requested to notify one of the study doctors.
Clinical trial: NCT02163317
Section: Procedures
Subsections: 3. Study Procedures|Prostate Biopsy Procedure|Blood Draws|Ct Scans|Bone Scan

In this study, you will have a multiparametric MRI to see where to focus your radiation therapy.  
You will then undergo radiation therapy treatment for 1 week (3 days out of the week will be radiation therapy). When radiation therapy is finished, you will follow up with your physician for up to two years.

Risks associated with biopsies include pain, redness, swelling, low blood pressure, excessive bleeding,  bruising,  or  draining  at  the  needle  site,  abnormal  wound  healing,  fever, infection, and allergic reaction to the medication used to numb the skin over the biopsy site. 23% of patients require hospitalization after a tumor biopsy.

The insertion of the needle to draw blood is painful; however, the discomfort is brief. For most people, needle punctures to get blood samples do not cause any serious problems; however, they may cause bleeding, bruising, discomfort, infections, dizziness, or fainting.

A liquid solution known as a contrast is frequently used in CT scans. The contrast is a solution used to make certain organs, blood vessels and tissues "stand out" to better image your disease. It is possible that you may develop an allergic response to the contrast agent. You may experience nausea, flushing, warmth and a salty taste. The dye can also cause water loss or damage to the kidneys, which may lead to kidney failure. This is a concern if you have poor kidney function, dehydration, or diabetes, especially if you take Metformin® (Glucophage) to control your diabetes. You will be asked not to move during the test, but relax and breathe normally. You might be uncomfortable while you are in the tunnel-shaped machine. Some patients have felt claustrophobic, or afraid of the enclosed space, during this test.  
There is also a slight risk of developing an allergic reaction to the iodine contrast material. The reaction can be mild (itching, rash) or severe (difficulty breathing or sudden shock). Death resulting from an allergic reaction is rare. Most reactions can be controlled using drugs. Be sure to tell your doctor if you have allergies of any kind (such as hay fever, iodine allergy, eczema, hives, or food allergies).  
You will be exposed to a limited and medically acceptable dose of radiation during the procedure. There is always a slight risk of cell damage from being exposed to any radiation, including the low levels of X-rays used for a CT scan. Everyone receives a small amount of unavoidable radiation each year. Some of this radiation comes from space and some from nturally-occurring radioactive forms of water and minerals. The CT scans done for this study will give your body the equivalent of about 3 extra years' worth of this natural radiation. If you are concerned with radiation exposure, please discuss this with your doctor.  
Magnetic Resonance Imaging (MRI)  
  
Project Title: CASE 11813: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer Principal Investigator: Elisha Fredman, MD
Sponsor: Case Comprehensive Cancer Center through an Elekta SBRT Research Grant patients may experience claustrophobia, or an inability to be in a confined space without being given a sedative (a drug used to calm them). In addition, you will hear loud, knocking noises.  
Occasionally, subjects will report a mild headache from the "knocking" sound. Temporary hearing loss has been reported from this loud noise. You will be asked to wear ear plugs. At certain times during the MRI, you may be asked not to swallow for a while, which can be uncomfortable.  
Watches and credit cards should also be removed as these could be damaged. You will be provided a way to secure these items. If you have any metal implants within the body you will not be able to undergo an MRI since metal implants interfere with the MRI system's magnetic field. You will still be able to participate in this study, but would have a CT scan instead of an MRI. Before you have the MRI scan, make sure to tell the operator/investigator if you have any of the following:  
a cardiac pacemaker or any other biomedical device in or on your body,
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any metal objects (especially surgical clips), devices, or implants that are in or on your
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body. In some cases, having those devices means you should not have an MRI scan performed.  
if you have metal-containing pigment in tattoo dye or permanent makeup. There have
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been reports of people with tattoos or permanent makeup who experienced swelling or burning in the affected areas. This seems to occur only rarely and apparently without lasting effects.  
any history of head or eye injury involving metal fragments,
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if you have ever worked in a metal shop, if you are claustrophobic (the fear of being in a narrow or enclosed space).  
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if you have had a previous reaction to Gadolinium-based contrast agents or a history of
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severe allergies. Subjects with severe kidney disease sometimes have a bad reaction to gadolinium contrast. The condition is called nephrogenic sclerosing fibrosis (NSF). It can cause skin to tighten or scar and can damage internal organs. Sometimes it can be lifethreatening. There are no reports of NSF in subjects with normal kidney function. Before you have a MRI or CT scan requiring an injection of gadolinium contrast, you will have a blood test in order to check the function of your kidneys. Based on your medical history and the results of the test, a doctor will decide whether it is safe for you to undergo the MRI or CT scans with a contrast agent.
We will use MRI contrast agent that is approved by the FDA and commercially available. There is a risk of an allergic or fibrotic reaction, which occurs more often with iodine based contrast
(for CT) than with MRI contrast agents. Every effort will be made to minimize the risk of such reactions in this study. Generally, an injection of contrast agent will be used. As with all such injections, bleeding, bruising, dizziness, fainting or infection may occur. Also, the injection may be painful but the discomfort should be brief and efforts will be made to minimize the pain.  
  
Project Title: CASE 11813: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer Principal Investigator: Elisha Fredman, MD
Sponsor: Case Comprehensive Cancer Center through an Elekta SBRT Research Grant The MRI scanner makes a loud buzzing sound during the exam that could affect your hearing. In order to protect you from this sound, you will be provided earplugs during the exam. There might also be some claustrophobia-related discomfort involved with being required to lie still in a small space. If this occurs, you can signal the technologist attending the MRI who will stop imaging.

A bone scan is a test that helps diagnose and track bone disease. A bone scan will be done when you first start the study. For a bone scan, you will receive an injection of a tracer into a vein in your arm. You will need to lie still on a table while a machine with an arm-like device supporting the camera passes over your body to record the pattern of the tracer being absorbed by your bones. This is painless. A scan of your entire skeleton will take up to 60 minutes. You may find the injection and the need to lie still during the scanning procedure mildly uncomfortable. The risk of an allergic reaction to the tracer is extremely rare. We are all exposed to radiation on a daily basis both from natural (sun and earth) and man-made sources that we call background radiation.
Clinical trial: NCT02163317
Section: Purpose of Research
Subsections: 2. Purpose

Focal Stereotactic Body Radiation Therapy (SBRT) is an investigational (experimental) form of radiation therapy for patients with prostate cancer. SBRT is delivered by a Food and Drug Administration (FDA) approved radiation therapy delivery device, using doses that are typical for a whole gland treatment. The investigational part of this study is selecting a part of the prostate shown on imaging to harbor cancer for treatment for high or focal radiation therapy that would spare areas of the prostate that are not found to have cancer on imaging studies. Focal image-guided radiation therapy is a new therapy that may be able to help patients experience fewer side effects by targeting only diseased tissue and avoiding healthy areas not shown to have cancer.  
  
Project Title: CASE 11813: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer Principal Investigator: Elisha Fredman, MD
Sponsor: Case Comprehensive Cancer Center through an Elekta SBRT Research Grant To help find the diseased tissue, this study will be using advanced magnetic imaging resonance
(MRI's) called "Multiparametric MRI". This is an MRI that can help to detect the difference between tumor tissue with non-tumor tissue. Another investigational part of this study is using the MRI to both guide treatment planning for focal therapy between therapy sessions and following therapy to assess changes in response to treatment. We will also use biopsy data with the MRI scans to identify pathology confirmed MRI scans so that we can better know the location of tumor.  
The main goal of this research study is to use multiparametric MRI's to better treat low to intermediate risk prostate cancer. Other purposes of this research study will be to hopefully help lead to less toxicity from focal SBRT and maintain a better quality of life for patients compared to treatment directed to the entire prostate gland.
Clinical trial: NCT02163317
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.  
  
Project Title: CASE 11813: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer Principal Investigator: Elisha Fredman, MD
Sponsor: Case Comprehensive Cancer Center through an Elekta SBRT Research Grant 1. Questions about the Research If you have any questions, you can ask the Principal Investigator and/or research staff at (216) (216)286-3903.  
If the researchers cannot be reached, or if you would like to talk to someone other than the researcher(s) about: concerns regarding the study, research participant's rights; research-related injury; or other human subjects issues, you may contact the University Hospitals Cleveland Medical Center's Research Subjects Rights Phone line at 216-983-4979.