Clinical trial: NCT05424783
Section: Confidentiality
Subsections: What Happens To The Information Collected For The Research?|Data Sharing|Hipaa Authorization

Efforts will be made to limit the use and disclosure of your personal information, including research study and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this institution. For example, study information which identifies you and the consent form signed by you may be looked at and/or copied for quality assurance and data analysis include:  
Representatives of the university committee and office that reviews and approves research studies, the Institutional Review Board (IRB) and Office for the Protection of Research Subjects.  
Other representatives of the State and University responsible for ethical, regulatory, or financial oversight of research.  
The sponsor of the research study, The US Department of Defense.  
Northwestern University (lead investigation site).  
USAMRMC Office of Research Protections, or Human Research Protection Office (HRPO)
A possible risk of the study is that your participation in the study or information about you and your health might become known to individuals outside the study. Your health information will be stored on a secured HIPAA compliant database to prevent access by unauthorized personnel. Your study information will be given to Dr. Adam Murphy at Northwestern University in a format that will not contain any information that can be used to identify individual participants and will only be shared via secured methods. Your individual data will be assigned a registration number. This number will be used in place of your name and any other personal identifying information on all study questionnaires and blood samples. Personal information about you that will be stored on a Northwestern secure database are your name and registration number, date of registration, age, sex, and race. Only authorized study personnel will have access to information linking personal identifying information to your registration numbers. Data sent to institutions outside of Northwestern will only know you by your registration number. All paper and electronic study materials will be kept in locked cabinets or password protected computers in locked offices. When the results of the study are published or discussed in conferences, no one will know that you were in the study.

De-identified data from this study may be shared with the research community at large to advance science and health. We will remove or code any personal information that could identify you before files are shared with other researchers to ensure that, by current scientific standards and known methods, no one will be able to identify you from the information we share. Despite these measures, we cannot guarantee anonymity of your personal data.

We are committed to respect your privacy and to keep your personal information confidential. When choosing to take part in this study, you are giving us the permission to use your personal health information that includes health information in your medical records and information that can identify you. For example, personal health information may include your name, address, phone number or social security number. Your health information we may collect and use for this research includes:
Results of physical examinations  
Medical history Lab tests, or certain health information indicating or relating to a particular condition as well diaries and questionnaires Records about study medication or drugs Records about study devices Billing information (such as hospital associated charges, and billing codes based on diagnosis and procedures done)
Results of other imaging studies Questionnaire responses Prostate cancer treatments, if applicable The results of your prostate biopsy Currently used medications and supplements
During this study, you may be coming to a recruiting site for research appointments or to get clinical services, such as lab tests, needed for the study. When that happens, you will be scheduled for these services through the recruitment sites' computer system. When a clinical exam or lab is done by NMHC or one of its employees for the purpose of this research study, that information will be kept in both the recruitment sites' clinical records and in the study records. Once we have the health information listed above, we may share some of this information with the following offices or entities outside of Northwestern University and its clinical partners (or affiliates): U.S. Department of Defense, the Human Research Protection Office, the Northwestern University Institutional Review Board Office and Office for Research Integrity; the US Office of Research Integrity; the US Office for Human Research Protections; the US Food and Drug Administration. Any research information shared with outside entities will not contain your name, address, telephone or social security number or any other personal identifier unless disclosure of the identifier is necessary for review by such parties or is required by law or University policy [except that such information may be viewed by the Study sponsor and its partners or contractors at the Principal Investigator's office]. The following entities may receive your health information:  
Authorized members of the Northwestern University workforce, who may need to see your information, such as administrative staff members from the Office for Research, Office for Research Integrity and members of the Institutional Review Board.  
The National Cancer Institute, who is sponsoring the study, and their contractors and partners.  
Clinical affiliates, including but not limited to those of Northwestern University, Jesse Brown VA, Cook County Health and University of Illinois at Chicago. Your participation in this clinical study may be tracked in an electronic database and may be seen by investigators running other trials that you are enrolled in and by your healthcare providers.  
Clinical affiliates, including but not limited to Northwestern Medical Group (NMG),
Northwestern Memorial Hospital (NMH), and Northwestern Lake Forest Hospital (NLFH), for purposes including, but not limited to, the affiliate's provision of care to
Clinical trial: NCT05424783
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Of The Prostate Mri With Gadolinium-Based Contrast Dye|Will It Cost Me Anything To Participate In This Research Study?

Some people cannot have an MRI because they have some type of metal in their body. For instance, if you have a heart pacemaker, artificial heart valves, metal implants such as metal ear implants, bullet pieces, chemotherapy or insulin pumps or any other metal such as metal clips or rings, you cannot have an MRI. During this test, you will lie in a small, enclosed area inside a large magnetic tube. Some people are scared or anxious in small places (claustrophobic). The MRI scanner makes loud banging noises while taking a measurement, so either earplugs or specially designed headphones will be used to reduce the noise. We have switched the Gadolinium-based contrast dye we use to Gadavist, which is safer than most gadolinium-based contrast dyes. Some people have allergic reactions to Gadavist. The dose for Gadavist (i.e., gadobutrol) to be given is 0.1mmol/kg through a peripheral vein at a rate of 2 ml/second for prostate MRI and is within FDA approved guidelines. If you experience shortness of breath or itching, please tell your technologist to stop the MRI. If you are on dialysis, you will need to have your prostate MRI done on the day of your dialysis before dialysis in order to remove the contrast dye from your system. We can do the MRI without the Gadavist also. You will be asked if you have any history of kidney problems or have had a kidney and/or liver transplant. Deposits of Gadolinium-based dyes remain in the brain of some patients who have undergone MRI scans with gadolinium-based dyes for a prolonged time after the last administration. Deposits of gadolinium-based dyes have also been reported in skin and bone. It is unknown whether these Gadolinium deposits are harmful or can have serious health effects. The dose and frequency of the contrast dye we are giving you is standard. We do not expect any additional risk to be posed to you beyond those already described above. You should avoid receiving additional Gadolinium-based contrast dye within 24 hours before or after the dose given in this research study.  
Your participation may make you feel emotionally uncomfortable, as we will ask questions about your medical history. Some of the questions we ask may be upsetting or you may feel uncomfortable answering them. If you do not wish to answer a question, you may skip it and go to the next question. You may experience mild to severe anxiety or nervousness during the MRI test that requires cancellation of the procedure. Although unlikely, it is possible that spots seen on the MRI scan are falsely positive, which will lead to biopsies of areas of the prostate that are not cancer. Risks and discomforts from the prostate biopsy would occur whether or not you participate in the research and includes: blood in the urine, blood in the semen, and blood of the toilet paper after a bowel movement for 1-2 days. There may be risks from the study that are not known at this time. Questionnaires: Some of the questions may make you feel uncomfortable or remind you of unpleasant aspects of your condition. You may skip any questions you do not wish to answer. A risk of this research is a loss of privacy (revealing to others that you are taking part in this study) or confidentiality (revealing information about you to others to whom you have not given permission to see this information). While we believe that the risks to you and your family are very low, we are not able to know all of the risks from taking part in genetic research studies. Your privacy will be protected to the fullest extent possible. Certain health concerns that affect you and your blood relatives might be found as inherited traits are studied. Even though your genes are unique, you share some of the same genes with your blood relatives. In addition, there may be undue stress, anxiety, or embarrassment resulting from inadvertent disclosure of information on family relationships, ethnic heritage, or potentially stigmatizing conditions. There is a Federal law called the Genetic Information Nondiscrimination Act (GINA). In general, this law makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. For example, life insurance companies may charge a higher rate based on this information. GINA also does not protect you against discrimination if you have already been diagnosed with the genetic disease that is being tested in this research study.

You and your insurance company will be charged for the health care services that you would ordinarily be responsible to pay. In some cases, insurance will not pay for services ordinarily covered because these services were performed in a research study. You should check with your insurance to see what services will be covered by your insurance and what you will be responsible to pay.
Clinical trial: NCT05424783
Section: Purpose of Research
Subsections: Why Is This Research Being Done?

We want to find out if the MRI and the Genomic Prostate Score (GPS) affect treatment choices and if it affects how closely the cancer is monitored over a 2 year period relative to men treated in the past. The purpose of this study is to recruit 222 men considering active surveillance for treatment in the MAGIC Study to provide meaningful data on active surveillance in men served in publicly funded hospitals. Our long-term goal is to improve the safety and uptake of active surveillance in publicly funded hospitals for improved survivorship for all prostate cancer participants. This study will compare results from men in this study to men previously recruited from the ENACT study that are on Active Surveillance to identify the factors that may affect the way the cancer is monitored. How long will the research last and what will I need to do? We expect that you will be actively involved in this research study for over a period of 6 months. We will follow you through the medical records for 2 years
Clinical trial: NCT05424783
Section: Voluntary Participation
Subsections: Why Am I Being Asked To Take Part In This Research Study?|I Agree I Disagree

We are asking you to take part in this research study because you are a male who has been diagnosed with very low to favorable intermediate risk prostate cancer, and you are willing to consider active surveillance for treatment.. This study involves a series of questionnaires, a magnetic resonance imaging (i.e., MRI scan), a blood draw, and the use of your prostate biopsy sample. Research studies answer important questions that might help change or improve the way we do things in the future.  
What should I know about a research study?  
Someone will explain this research study to you.  
Whether or not you take part is up to you.  
You can choose not to take part.  
You can agree to take part and later change your mind.  
Your decision will not be held against you.  
You can ask all the questions you want before you decide.

The researcher may contact me in the future to see whether I am interested in participating in other research studies by the Principal Investigator of this study. The researcher may retain any leftover blood, DNA or tissue samples taken during the study. These samples may be used for other research not related to this study. These samples will be retained in non-identifiable form, meaning that there will be no information associated with the blood, DNA or samples that will allow anyone to readily ascertain my identity.
Your signature documents your permission to take part in this research. You will be provided a copy of this signed document.  
 Printed Name of Person Obtaining Consent
Clinical trial: NCT05424783
Section: Withdrawal from Study
Subsections: What Happens If I Do Not Want To Be In This Research?|What Happens If I Say "Yes", But I Change My Mind Later?|Can I Be Removed From The Research Without My Ok?

Participation in research is completely voluntary. You decide whether or not to participate. If you choose to not participate, there will be no penalty to you or loss of benefit to which you are entitled. Your alternative to participating in this research study is to not participate. If you decide not to enter this study, there is other care available to you including an MRI of the prostate or an Oncotype DX test outside of the study. The study doctor will discuss these with you. You do not have to be in this study to be treated for prostate cancer.  
Detailed Information:
The rest of this document includes detailed information about this study (in addition to the information listed above).

You can leave the research at any time; it will not be held against you. If you decide to leave the research, contact the investigator so that the investigator can provide advice about how to leave the study. If you choose to no longer be in the study and you do not want any of your future information to be used, you must inform the researchers in writing at the address provided. The researchers may use your information that was collected prior to your written notice. Choosing not to be in this study or to stop being in this study will not result in any penalty to you or loss of benefit to which you are entitled. Specifically, your choice not to be in this study will not negatively affect your right to any present or future medical treatment, class standing (for students enrolled in a class at NU), or your present or future employment (for employees at NU or its affiliates). Detailed Risks: Is there any way being in this study could be bad for me? The procedures in this study may cause all, some, or none of the risks listed below: Blood Draw/Venipuncture: The risks of taking blood include pain, a bruise at the point where the blood is taken, redness and swelling of the overlying skin and infection, and a rare risk of fainting. Care will be taken to reduce these risks.

The person in charge of the research study or the sponsor can remove you from the research study without your approval. Possible reasons for removal include that the researchers or the