Clinical trial: NCT03388619
Section: Alternatives
Subsections: Standard Of Care Treatment|Alternative Approaches Or Treatments What Other Choices Do I Have If I Do Not Take Part In This Study?

Treatments covered under this study may include a single medication or a combination of medications, surgery or radiation to treat your cancer. These treatments will not be experimental. Your doctors will describe your treatment plan to you in detail before asking you to sign this consent form. You may be asked to sign a separate consent form for any treatment procedures not outlined in this consent.

Instead of being in this study, you have these options:
Getting treatment or care for your cancer without being in a study, including receiving standard radiation over 6-7 weeks Taking part in another study Please talk to your doctor about these and other options.
Clinical trial: NCT03388619
Section: Confidentiality
Subsections: Protections Against Misuse Of Genetic Information|Confidentiality Protections Provided In This Study|Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality|Privacy Act

This study involves genetic testing on samples. Some genetic information can help predict future health problems of you and your family and this information might be of interest to your employers or insurers. The Genetic Information Nondiscrimination Act (GINA) is a federal law that prohibits plans and health insurers from requesting genetic information or using genetic information. It also prohibits employment discrimination based on your health information. However, GINA does not address discrimination by companies that sell life insurance, disability insurance, or long-term care PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**
NIH-2977 (4-17) File in Section 4: Protocol Consent (1) Version Date: 05/08/2023 Page 8 of 14 CC pre rCR ICF template v. 05.05.2020 insurance. GINA also does not protect you against discrimination based on an already-diagnosed condition or disease that has a genetic component.

Some of your health information, and/or information about your specimen, from this study will be kept in a central database for research. Your name or contact information will not be put in the database. Your test results will be identified by a unique code and the list that links the code to your name will be kept separate from your sample and health information. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you.

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
The NIH and other government agencies, like the Food and Drug Administration (FDA),
which are involved in keeping research safe for people.  
National Institutes of Health Intramural Institutional Review Board The study Sponsor, Center for Cancer Research, or their agent(s)
The researchers conducting this study and the NIH follow applicable laws and policies to keep your identifying information private to the extent possible. However, there is always a chance that, despite our best efforts, your identity and/or information about your participation in this research may be inadvertently released or improperly accessed by unauthorized persons. In most cases, the NIH will not release any identifiable information collected about you without your written permission. However, your information may be shared as described in the section of this document on sharing of specimens and data, and as further outlined in the following sections. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances.  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
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NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court. The Certificate does not protect your information when it:
1. is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or 2. is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
3. is for other research; 4. is disclosed with your consent.  
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.

The Federal Privacy Act generally protects the confidentiality of your NIH medical records we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your medical record without your permission, for example, if it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.
Clinical trial: NCT03388619
Section: Duration of Study Involvement
Subsections: When You Are Finished With Radiation Treatment

About 4 - 5 weeks after you have finished radiation treatment, you will be asked to return for a safety follow up visit. At this visit, we will ask questions about your health, perform a physical exam and collect blood for research. After the safety visit, we will ask you to come for follow up visits on months 3, 6, 9, 12, 15, 18, 21 and 24. At these visits, your will be asked questions about your health and any other medications you may have taken. During some of these visits you will have PSA, testosterone level tests, immune system testing (white blood cells), blood and urine collected for research purposes, one MRI (6 months after treatment) and we will ask you to complete questionnaires assessing your well-being.  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
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If you are unable to return for these visits, we will obtain the information from you by telephone, email, video call or refer you to your local provider.
Clinical trial: NCT03388619
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation|Risks From Radiation Overall Radiation Risk|Radiation Treatment Risk|Risks From Mri|Risks From Mri Gadolinium|Risks From Blood Draws|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?|Risks Of Returning Secondary Genetic Findings|Benefits Of Returning Secondary Genetic Findings

What side effects or risks can I expect from being in this study? If you choose to take part in this study, there is a risk that:
You may lose time at work or home and spend more time in the hospital or doctor's office than usual You may be asked sensitive or private questions which you normally do not discuss The radiation used in this study may affect how different parts of your body work. Here are important points about side effects:
The study doctors do not know who will or will not have side effects.  
Some side effects may go away soon, some may last a long time, or some may never go away.  
Here are important points about how you and the study doctor can make side effects less of a problem:  
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Tell the study doctor if you notice or feel anything different so they can see if you are having any symptoms.  
The study doctor may be able to treat some side effects.
The study doctor may adjust the study drugs to try to reduce side effects.  
Below we show the most common and the most serious side effects that researchers know about. There might be other side effects that researchers do not yet know about. If important new side effects are found, the study doctor will discuss these with you.

During a year in this research study, if your tumor is visible in imaging assessments, you may be exposed to up to approximately 60.4 Gy of radiation in 20 treatment sessions, or up to 54.6 Gy in 15 sessions or up to 47.1 Gy in 10 sessions. If your tumor is not visible in imaging assessments, you may be exposed to up to 56.4 Gy in 20 treatment sessions, or 51.2 Gy in 15 sessions, or 44.2 Gy in 10 sessions. This radiation has been reviewed by the NIH Radiation Safety Committee and deemed appropriate for this study.

It is impossible to predict exactly what side effects and individual may have during or after a radiation treatment, but, in general, radiation side effects are usually limited to the part of the body being treated. Radiation can have side effects that occur during or shortly after the treatment, and a separate set of side effects that can happen month to years later. The side effects listed below are seen after radiation to the same area of the body with more prolonged treatments. It is not known if the risks of these side effects will be similar for this compressed treatment. During or shortly after the treatment:  
Common: mild fatigue, burning with urination, more frequent urination (including urinating at night), more frequent bowel movements, more urgent bowel movements, hemorrhoid irritation, mild irritation or dryness of skin in the area being treated, thinning of hair in the area being treated.  
Uncommon: decreased blood count that could lead to infection or bleeding, mild aching in the area treated.
Months to years after the treatment:  
Common: increased frequency or urgency of urination, increased feelings of gassiness, decreased ability to have or maintain an erection, more frequent or urgent bowel movements.  
Uncommon: bleeding from the bladder, bleeding from the rectum, decreased urinary control (increase in leakage).  
Rare: Severe damage to bladder or bowel that could require a surgery to correct.  
Extremely rare: cancer caused by radiation.  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
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The main discomfort of an MRI is lying still on the scanning table for up to 60 minutes. Some people are bothered by the repetitive thumping noise of the MRI machine (ear plugs will be provided). Some people feel claustrophobic inside the narrow scanning machine. Cool circulating air and soft lighting helps to ease these feelings. If you are very claustrophobic, you may ask your physician for a mild sedative for the procedure, but you must not drive a vehicle until the sedative wears off. MRI scans cannot be done on people who have metal implants, including cardiac pacemaker, neural pacemaker, surgical clips in the brain or blood vessels, or other implanted metal objects.

The risks of an IV catheter include bleeding, infection, or inflammation of the skin and vein with pain and swelling. Mild symptoms from gadolinium infusion occur in fewer than 1% of those who receive it and usually go away quickly. Mild symptoms may include coldness in the arm during the injection, a metallic taste, headache, and nausea. In an extremely small number, fewer than one in 300,000 people, more severe symptoms have been reported including shortness of breath, wheezing, hives, and lowering of blood pressure. You should not receive gadolinium if you previously had an allergic reaction to it. You will be asked about such allergic reactions before gadolinium is given. People with kidney disease are at risk for a serious reaction to gadolinium contrast called "nephrogenic systemic fibrosis (NSF)". This condition always involves the skin and can also involve the muscles, joints and internal organs. NSF has resulted in a very small number of deaths. A blood test of your kidney function may be done within the month before an MRI scan with gadolinium contrast. You will not receive gadolinium for a research MRI scan if your kidney function is below the safe level. Most of the gadolinium contrast leaves the body in the urine. However, the FDA has issued a safety alert that indicates small amounts of gadolinium may remain in the body for months to years. The long-term effects of the retained gadolinium are not unknown. Some types of gadolinium contrast drugs are less likely to remain in the body than others. In this study, we will use the gadolinium contrast drugs that are less likely to remain in the body. We will also give you additional information called a "Medication Guide." Upon request, we will give you individual information about retained gadolinium we see on your studies.

pain at the needle site  
bruising possible dizziness if you stand up quickly possible inflammation of the vein or infection at the needle site.  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
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The aim of this study is to determine how rapidly radiation can be safely delivered after a prostatectomy. We do not know if you will receive personal, medical benefit from taking part in this study. Potential benefits could include long term suppression of your PSA level and potentially curative treatment of the remaining prostate cancer. Radiation is a potentially curative treatment when used in your situation.

The evaluation for unexpected gene changes is limited and may not be as complete as clinical genetic testing that might be available to you outside of the research study.  
If an unexpected gene change result is confirmed, then that test result will go into your NIH
medical record. These documents are confidential, but other NIH investigators can see them.  
Learning about the changes in your genes could mean something about your family members and might cause you or your family distress. Before joining the study, it may be helpful to talk with your family members about whether they want you to share your results with them.  
If a gene change is found, it may reveal whether a particular parent passed on the change to a biological child.  
You may receive a result for an unexpected gene change that turns out not to cause that health condition. This may cause you unnecessary distress or lead to unnecessary medical testing risks and costs.

An unexpected gene change result may be useful because you may be able to do something about it to protect your health or to help you plan for your future.
Clinical trial: NCT03388619
Section: Procedures
Subsections: During The Study Before The Start Of Radiation Treatment We Will Perform:|Radiation Treatment|Research Tests

Physical examination, including vital signs, review of your symptoms and your ability to perform your normal activities.  
Routine blood tests to find out if you are anemic, have low blood counts, the status of your immune system and if your liver, kidneys, and other organs are working well. Up to 1 tablespoon of blood may be collected.  
Blood tests to evaluate PSA and testosterone levels. Up to half a tablespoon of blood may be collected.

Radiation will be administered in daily fractions Monday through Friday except in the case of machine malfunction or federal holiday. Depending on when you enter the study, treatment may last 2, 3 or 4 weeks.  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
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We are planning to collect blood and urine samples from you for purposes of research only. These samples will be used to study your response to treatment, including evaluation of cancer cell death and damage to normal cells:  
Blood and urine samples will be drawn before you start the treatment, within 24 hours after the last dose of irradiation, at 1, 3, 6, 9, 12, 15, 18, 21, 24 months after completion of treatment. Up to 3 and a half tablespoon of blood may be collected at each visit.  
If available, we will ask you to provide tissue sample from prostatectomy or biopsy for research purposes.  
You also will be asked to complete questionnaires to determine you general well-being and function - before you start the treatment and every 6 months after completion of treatment for 2 years. It will take you about 20 minutes and will only be done if you can complete the surveys in English.  
You will be asked to have a magnetic resonance imaging (MRI) that uses a magnetic field to produce an image of your prostate bed 6 month after completion of your treatment.  
Genetic testing - Your tissue samples contain genes, which are made up of DNA
(deoxyribonucleic acid) which serves as the "instruction book" for the cells that make up our bodies. We will use the tissue samples and blood you provided to learn about how the genes in your tumor compare to genes in normal tissue. Your tissue will help us study how genes might play a role in prostate cancer and other diseases. We will not share the results of these research tests with you.
When we are conducting the above genetic tests, it is possible that we could identify changes in other parts of your DNA that are not related to this research. These are known as "incidental medical findings". However, the analyses that we perform in our laboratory are for research purposes only; they are not nearly as sensitive as the tests that are performed in a laboratory that is certified to perform genetic testing. Changes that we observe unrelated to our research may or may not be valid. Therefore, we do not plan to inform you of the results of testing on your tissue and blood that is performed in our research lab. There may be exceptions to what we share with you and this is described later in this consent form in the section for "Return of research results."
Clinical trial: NCT03388619
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?|Description Of Research Study Before The Study

Prostatic Specific Antigen (PSA) is usually measured after surgical removal of the prostate to determine if the tumor is returning. In cases when PSA is rising and there is no evidence of spread of prostate cancer to areas outside of the pelvis, the standard treatment is radiation to the area where the prostate was located before surgery, which is also known as the prostate bed. Radiation is a commonly used treatment for prostate cancer that has returned after prostatectomy. Radiation kills prostate cancer cells and can be very effective. This treatment is most commonly given as a short daily treatment, five days per week, for 6-7 weeks. This treatment can offer the chance of  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
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cure and can provide PSA control in most of the patients who receive the treatment, but may have side effects. In this study, we are trying to understand if a shortened, or compressed, radiation treatment schedule can be as effective as standard treatments with similar or reduced side effects. We plan to deliver the radiation dose in progressively shorter total treatment times, with the goal of reducing the length of treatment from the currently used 6-7 weeks to 2, 3, or 4 weeks. Because the radiation treatment is given over a shorter total time, it is delivered in higher than standard dose fractions. The goal of this study is to find the most compressed radiation schedule that people can tolerate without strong side effects.

You are being asked to participate in this study because you have had a prostatectomy and have reasons that radiation is being recommended, such as a detectable PSA or worrisome findings on pathologic review of the tumor that was removed at the time of surgery.

Before you begin this study, you will need to have exams and tests to make sure you are eligible for this study. The exams and tests are usually part of regular cancer care. These tests will be done under a separate consent. We will collect the records about your medical history, diagnosis, and this screening testing for the study.
Clinical trial: NCT03388619
Section: Voluntary Participation
Subsections: It Is Your Choice To Take Part In The Study

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.
Clinical trial: NCT03388619
Section: Withdrawal from Study
Subsections: Stopping Therapy

Your doctor may decide to stop your therapy for the following reasons:
if he/she believes that it is in your best interest if you have side effects from the treatment that your doctor thinks are too severe  
if new information shows that another treatment would be better for you if the investigator decides to end the study
In this 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. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be provided to designated representatives. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot be recalled and destroyed.