Clinical trial: NCT03429244
Section: Alternatives
Subsections: Alternatives To Taking Part In The Study

Instead of being in the study, you may choose not to participate and continue your regular cancer treatment, including the standard imaging scans. Medical care will not be withheld if you choose not to participate.
Clinical trial: NCT03429244
Section: Confidentiality
Subsections: Confidentiality

Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. Your identity will be held in confidence in reports in which the study may be published and databases in which results may be stored. Organizations that may inspect and/or copy your research records for quality assurance and data analysis include groups such as the study investigator and his/her research associates, the Indiana University Institutional Review Board or its designees and (as allowed by law) state or federal agencies, specifically the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA), the National Cancer Institute (NCI), who may need to access your medical and/or research records.  
A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Clinical trial: NCT03429244
Section: Participant's Rights
Subsections: Subject'S Consent

In consideration of all of the above, I give my consent to participate in this research study. I will be given a copy of this informed consent document to keep for my records. I agree to take part in this study.  
Subject's Signature: **Date**:_____________ (must be dated by the subject)  
Subject's Printed Name:__________________________________________________ Signature of Person Obtaining Consent:_________ ____________**Date**:____________ Printed Name of Person Obtaining Consent:__________________________________
Clinical trial: NCT03429244
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Of Taking Part In The Study

While on the study, the risks are:
1. Loss of confidentiality. During this study, we will collect information about your medical condition and the results of the scans. To minimize the risk that your medical information might be seen by persons who are not involved in the study, our files are kept in a secure area. Also, your name will never appear in any research reports. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law (such as when the FDA asks to review our files).  
2. *Radiopharmaceutical Administration and PET/MR.* The amount of this radioactive imaging agent is so small that you should not experience any drug effects whatsoever. In the very rare event this occurs
(similar to an allergic reaction), our personnel are trained to quickly recognize and treat it. Signs of an allergic reaction include: rash, itching, swelling, and shortness of breath. Possible risks from placing a tube in your arm vein include bruising, and rarely, infection. To minimize the risks, all procedures will be performed by certified nuclear medicine technologist trained to perform clinical PET imaging studies using sterile (very clean) procedures. Your participation in this research study involves exposure to radiation in addition to what you may receive as part of your standard care. The benefit from the radiation you receive for your standard care typically outweighs the risk because it allows your doctor to provide appropriate medical care; however, the additional radiation "dose" you receive for research purposes may not benefit you personally.  
Regulatory agencies have established annual radiation dose limits for individuals who work with radiation (e.g. x-ray technologists, radiologists, etc.). If you decide to participate in this research study, the radiation dose you receive will not be above the annual limit for radiation workers. Radiation has been shown to cause cancer and/or leukemia from doses that are higher than the additional annual radiation dose you will receive by participating in this study. According to the Health Physics Society (an international organization that specializes in radiation protection), the increased risk of health effects from the additional annual radiation exposures in the range of those you will receive while participating in this research study is either too small to be observed or nonexistent in the normal population. While there is no evidence that any risk exists for humans exposed to this amount, it is assumed that the risks rise with lifetime accumulated dose from all sources of ionizing radiation, including the doses you receive from medical procedures and the environment. You should also be aware that everyone's sensitivity to radiation is not the same and some diseases (e.g. genetic diseases, diseases affecting DNA repair, and immune diseases such as HIV) may make you more sensitive to the effects and consequences of the radiation exposure than the normal population. Finally, you should know that even if there is an increased risk of an effect, it could be 5 to 20 years before any effect would actually occur. Thus, you may want to factor in your age, overall health, and the number of medical radiation procedures that you've had when determining if this risk is acceptable to you. The calculated effective dose resulting from your participation in this study is available upon request.  
3. Since this is an investigational study there may be risks that are unknown or unforeseeable. Your participation could be terminated by the investigators at any time if significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise your ability to complete the study, and/or compromise the objectives of the study.
Clinical trial: NCT03429244
Section: Procedures
Subsections: Procedures For The **Study**

If you agree to be in the study, you will do the following things: You will be screened to ensure you meet all inclusion and exclusion criteria. Your medical history will be taken. Briefly, you must be diagnosed with prostate cancer with plan for standard of care template and fusion biopsy and/or prostate removal, or focal therapy at Indiana University.  
You will receive a single intravenous injection of the 68Ga-PSMA-11 radiopharmaceutical, followed by a PET/CT scan. The results of this scan will be discussed with you.  
The PET scan is expected to be performed using a combined PET/MR camera. The research PET imaging will occur as you are undergoing your standard-of-care prostate MR imaging. The PET scan involves the following steps:  
a. An intravenous tube, or line, will be placed in one of your arm veins to allow for injection of the radioactive substance.  
b. You will be asked to empty your bladder. On returning to the injection room, the 68Ga-PSMA-11 radiopharmaceutical will be injected via the intravenous tube, followed by flushing of that tube with sterile saline solution.  
c. Approximately 5-minutes after the radiopharmaceutical injection you will be asked to lie down on your back on a platform on the PET/CT scanner. The scanner will collect PET images over the course of your standard of care MR imaging procedure, which will require about 45-minutes.  
d. The intravenous line will be removed, and you will be allowed to leave the imaging facility.  
You will be monitored while at the imaging site to observe for any adverse events. You may be contacted to undergo a second 68Ga-PSMA-11 PET scan approximately 6-12 months after the initial scan if you undergo high-intensity focused ultrasound and/or if you are rescheduled for MRIfusion biopsy as standard of care during follow-up.
Clinical trial: NCT03429244
Section: Purpose of Research
Subsections: Study **Purpose**

The purpose of this study is to evaluate a radiopharmaceutical (a radioactive imaging agent) called 68GaPSMA-11. This imaging agent seeks to identify prostate cancer based on its expression of a specific protein target, prostate-specific membrane antigen (PSMA), which is known to be present at high levels on the surface of most prostate cancer cells. The tests will involve using the radioactive agent (68GaPSMA-11) for a pre-biopsy and/or surgical positron emission tomography (PET) scan of your pelvis to look for evidence of tumor locations. Your planned prostate cancer management is not being changed by participation in this research study. But, there is a chance that the PET scan might lead your physician to request sampling at one or two additional sites within the prostate during your scheduled biopsy, if he/she is concerned that a suspected cancer site seen on PET might otherwise be missed in a standard biopsy. The post-treatment analysis is focused on analysis of tissue that is going to be removed whether or not you choose to participate in the research. The 68Ga-PSMA-11 radiopharmaceutical is investigational, which means it has not yet been approved by the Food and Drug Administration (FDA). However, it has been used for prostate cancer imaging in hundreds of prior patient PET/CT exams, primarily in Europe.
Clinical trial: NCT03429244
Section: Voluntary Participation
Subsections: Voluntary Nature Of Study

Taking part in this study is voluntary. You may choose not to take part, or may leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled. Your decision whether or not to participate in this study will not affect your current or future relations with Indiana University Health or the Departments of Urology or Radiology and Imaging Sciences, Indiana University School of Medicine. If you want to stop being in the study, tell the study doctor or study staff. If you decide to stop being in the study, the study doctor or study staff may ask you some questions about when you were in the study. If you, or your study doctor, decide to stop your participation from the study you may be asked to return for follow-up visits to help monitor your health and condition.  
During the course of the study, if we receive any important new information about the study, that might change your mind about continuing in the study, the study doctor or study staff will tell you about it. You are free to withdraw your consent from the study at any time. Your participation could be terminated by the investigators at any time if significant acute or chronic medical, neurologic, or psychiatric illness in you that, in the judgment of the Principal Investigator, could compromise your safety, limityour ability to complete the study, and/or compromise the objectives of the study.