Clinical trial: NCT03373006
Section: Alternatives
Subsections: Alternative Treatment

If you decide not to enter this study, there are other choices available. These include: Following the treatment and management plan that would be part of standard of care for your prostate cancer, including other imaging options, such as MRI or choline C PET Scan. Ask the Study Doctor to discuss these alternatives with you. You do not need to be in this study to receive treatment for your condition.
Clinical trial: NCT03373006
Section: Confidentiality
Subsections: Confidentiality|Authorization To Use And Disclose Information For Research Purposes|Who Might Get This Information?

By signing this informed consent document, you allow access to your medical records to the Study Doctors and their staff, the Sponsor or its representative, representatives of the IRB and representatives from the US FDA, or other regulatory agencies and representatives from Blue Earth Diagnostics. Because of the need to release information to these parties, absolute confidentiality cannot be guaranteed. However, all recipients of any information pertaining to your participation in this research study will treat the information as confidentially as possible based on applicable laws and regulations. The results of this study may be reported or published. However, you will never be identified by name nor will other personal identifying information about you be released.

What information may be used and given to others? The Study Doctor will get your personal and medical information. For example:
Past and present medical records Research records Records about phone calls made as part of this research Records about your study visits Who may use and give out information about you?  
The Study Doctor and the Study Staff.

The Sponsor of this research. "Sponsor" means Any representatives from Desert Medical Imaging.  
People who are working for or with the sponsor, or Owned by the Sponsor.  
Your information may be given to:
The U.S. Food and Drug Administration (FDA),
Department of Health and Human Services (DHHS) agencies, Governmental agencies in other countries, Western Institutional Review Board® (WIRB®).  
Representatives from Blue Earth Diagnostics. California Cancer Registry Why will this information be used and/or given to others?  
To do the research, To study the results, and To see if the research was done right.  
What if I decide not to give permission to use and give out my health information? Then you will not be able to be in this research study. May I review or copy my information? Yes, but only after the research is over. May I withdraw or revoke (cancel) my permission? This permission will be good until January 1, 2020. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the Study Doctor. If you withdraw your permission, you will not be able to stay in this study.  
WIRB
When you withdraw your permission, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others. Is my health information protected after it has been given to others? Although your study information does not use your name or other personal identification, there is a risk that your information will be given to others without your permission. Signature of Participant Date ________________________________________________ Printed Name of Participant
Clinical trial: NCT03373006
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks And Discomforts|Risks Related To Radiation|Risks Related To Other Study Procedures|Reproductive Risks|Other Risks

To date, at least 2000 people have received a fluciclovine F-18 injection. Side effects are generally uncommon, however people have experienced the following: Injection site pain (less than 0.1%), change in taste sensation in the mouth (less than 0.1%), and headache (less than 0.1%). Allergic and similar type reactions, including life-threatening ones, may occur. Tell your doctor if you have a side effect or feel unwell. Contact the Study Staff **immediately** if you:
Have a side effect that concerns you, or Are unable to perform your daily functions.

This study involves exposure to a small amount of radiation. Radiation is part of our natural environment. We are exposed to background radiation from materials in the earth itself, from naturally occurring radon in the air, from outer space, and from inside our own bodies (as a result of the food and water we consume). The level of radioactivity you are exposed to during this study is equivalent to the background radiation you would be exposed to during approximately 2
½ years. The main risk associated with all radiation exposure is the possibility of developing a radiation-induced cancer later in life. At these exposure levels, the risk is small.

On the day of the scan you will have an intravenous catheter placed in your arm. Like blood draws, there is a risk of bruising, discomfort and pain, and in rare cases a chance of infection. There is the risk that the PET/CT scan may provide a false positive image (giving the appearance of cancer) in sites where it is not present, due to other events in the body such as inflammation or a false negative result (failing to detect cancer). If your treatment plan is altered due to falsepositive results, you may undergo unnecessary biopsies or treatment. If the PET/CT scan provides false-negative results, you may not be offered adequate treatment for your cancer. In a small percentage of men scanned with fluciclovine F 18, the PET/CT scan has detected other (non-prostate cancers) which were not suspected at the time of scanning. This could provide useful information, but may also result in additional stress or anxiety.

Animal reproduction studies have not been conducted with fluciclovine F 18. It is not known whether fluciclovine F 18can cause fetal harm when administered to a pregnant woman or affects male fertility. You will be slightly radioactive for up to 24 hours after the injection and should avoid close contact with women who are able to have children, and with children, for 24 hours after the scan.

There may be risk of infection or hematoma (blood accumulation) at the site of injection. There may be side effects that are not known at this time.
Clinical trial: NCT03373006
Section: Procedures
Subsections: Screening Visit (Up To 30 Days Before The Scan)|Day Of The Pet/Ct Scan|After The Scan

Before the study starts, you will be asked to sign this informed consent form, and a member of the Study Staff will ask you about your general health history, treatments you have had for prostate cancer, if you take any over-the-counter or prescription medicines, vitamins, or herbs, and if you have any drug allergies. The Study Staff will also record information from your medical records including previous blood test results, procedures, treatments, and plans for your prostate cancer treatment. The Study Staff may do some tests as part of the study at this visit. If these tests are not done at this visit then they will be done on the day of the scan before you have the scan. These tests include:
Assessment of vital signs (blood pressure and heart rate)
Routine blood tests If you agree to participate in the study and you qualify for the study, then you will be scheduled for the fluciclovine F 18 PET/CT scan within 30 days. The Study Staff will tell you when and where the PET/CT scan will be performed. You should not exercise the day before the scan and until the scan is finished. Do not eat or drink for at least 4 hours before the scan; sips of water to take medication are permitted.

Before the fluciclovine F 18 dosing and PET/CT scan, a member of the Study Staff will ask you questions about your general health and medications. The Study Staff will place an IV catheter (long, thin tube) into a vein in your arm. You will receive the fluciclovine F 18 injection through the catheter in your arm immediately before the scan. During the scan, you will lie on your back on the scanning bed. The bed will move slowly through the PET/CT scanner. The CT portion of the scan usually takes about 1 minute, and sends X-rays through the body that are measured by the CT camera. The PET portion of the scan begins about four minutes after the injection and usually takes about 30 minutes.

After the scan, the images will be read. If there are features in the image that indicate that your prostate cancer is not localized in the prostate, you may no longer be eligible for certain forms of therapy. You will be asked to remain at the scanning site for 2 more hours to make sure that you have no delayed reactions to the scan. The whole visit for the scan and the follow up should take approximately 3-4 hours.
Clinical trial: NCT03373006
Section: Purpose of Research
Subsections: Purpose Of The Study

Prostate cancer is one of the most common cancers in men. Some of the ways that a doctor can detect prostate cancer is by measuring PSA levels in your blood, or by removing samples of the prostate to see if signs of the disease are found in the samples (this is called a biopsy). Imaging tests, like a bone scan, MRI (magnetic resonance imaging) or CT (computed tomography), are often performed to help the doctor determine where or how much cancer there is, and how best to treat the cancer. If the disease is limited to the prostate only, and has not spread to your lymph nodes or other parts of your body, you may have treatment options that are not available to you if the disease has spread. The purpose of this experimental study is to use an imaging agent known as fluciclovine F 18 to help determine where in the body your cancer is located. Fluciclovine F 18 is a radioactive tracer has been approved by the FDA for the detection of recurrent prostate cancer in men (in other words, men who have already been treated for prostate cancer, and now have signs that the disease has returned). However, fluciclovine F 18 use is experimental when used to image prostate cancer that has not yet been treated. Fluciclovine 18 is used in combination with a CT scan. When a radioactive tracer is used in combination with a CT scan, the procedure is called a PET/CT (PET = positron emission tomography).
Clinical trial: NCT03373006
Section: Voluntary Participation
Subsections: Voluntary Participation And Withdrawal

Your participation in this study is voluntary. You may decide not to participate or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled.  
Your participation in this study may be stopped at any time by the Study Doctor or the Sponsor without your consent for any reason, including:
If it is in your best interest If you do not consent to continue in the study after being told of changes in the research that may affect you You require a medication that is not allowed while participating in the study You develop a condition which may negatively affect your health You do not follow the study instructions given by the Study Staff You withdraw your consent to participate The Sponsor decides to suspend or terminate (end) the study or the participation of this site in the study Other unanticipated circumstances
If you decide to withdraw from this study, please inform your Study Doctor right away.