Clinical trial: NCT02649439
Section: Alternatives
Subsections: Alternative Approaches Or Treatments What Other Choices Do I Have If I Do Not Take Part In This Study?

Instead of being in this study, you have these options:  
- Taking part in another study
- Getting treatment with standard therapy outside this study.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
- Observation only, where your doctor, depending on his clinical judgment and your opinion, follows your PSA and watches you for cancer recurrence.
Please talk to your doctor about these and other options.
Clinical trial: NCT02649439
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality

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 National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people.  
- National Cancer Institute Institutional Review Board - The study Sponsor, Center for Cancer Research, or their agent(s)
- Qualified representatives from Bavarian Nordic, Inc., the pharmaceutical company who produces prostvac vaccine.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
A description of this clinical trial will be available on http://www.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.

To help us protect your privacy, we have obtained a Certificate of Confidentiality. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. You should also know that there are several circumstances in which the Certificate does not provide coverage. These include when information:  
- will be used for auditing or program evaluation internally by the NIH; or - must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA).  
- is necessary for your medical treatment and you have consented to this disclosure;
- is for other research.  
In addition, identifiable, sensitive information protected by this Certificate cannot be admissible as evidence or used for any purpose in any action, suit, or proceeding without your consent.
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information. The Certificate of Confidentiality will not protect against the required reporting by hospital staff of information on suspected child abuse, reportable communicable diseases, and/or possible threat of harm to self or others.
Clinical trial: NCT02649439
Section: Duration of Study Involvement
Subsections: During The Study

Once you agree to participate in this study, you will be assigned to 1 of 2 groups/arms
- Arm A: prostvac for 6 months with an additional optional year of maintenance for eligible patients.  
- Arm B: Surveillance for 6 months followed by prostvac for 6 months with an additional optional year of maintenance for eligible patients.
Prostvac will be administered as a shot under the skin on week 1 (vaccinia version of the vaccine) and then week 3, 5 and then monthly (fowlpox version of the vaccine) for a total of 5 months. For description of the versions of the vaccine and explanation of why there are two versions, please see below under Vaccinia Virus and Fowlpox Virus. At each visit we will give you a physical exam and standard blood tests, and ask you how you are feeling. This is standard care you would receive as part of your cancer treatment, whether you were participating in a study or not. Electrocardiogram (ECG) to check your heart function will be done at baseline. As part of this study, we will look for any signs that your cancer is recurring or getting worse:  
- Your PSA level will be checked at each visit when blood is taken for standard laboratory tests.  
- Bone scan will be done at baseline and at 6 months or earlier if needed.  
- CT scan of the chest, abdomen, and pelvis or MRI will be done at baseline and at 6 months or earlier if needed.
Clinical trial: NCT02649439
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:  
- You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
- There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs if they are not covered by your insurance company.  
- Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Clinical trial: NCT02649439
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Additional Risks And Side Effects Related To The Vaccine Therapy With Prostvac-V/Tricom And Prosvtac-F/Tricom|Other Potential Side Effects|Risks To An Unborn Child And Sexual Partner Birth Control|Other Risks|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

Likely: - Injection site reaction (pain, swelling, itching, induration, and redness) - Tiredness, weakness
- Fever
- Shaking chills - Nausea - Glands, (lymph node) enlarge and become tender Less likely: - Headache - Allergic reaction - Sweating - Wound complication - Vomiting - Confusion and disorientation - Loss of appetite - Yeast infection - Constipation - Cough - Diarrhea - Indigestion - Fatigue - Facial tingling - Muscle ache - Nausea - Facial numbness - Pruritus (itching) Rare but serious: - An uncommon blood condition called thrombotic thrombocytopenic purpura (TTP). One patient treated with this vaccine developed TTP. It is not known if this was related to the vaccine or from something else. This is a serious disease that is associated with low blood counts (both red blood cells that carry oxygen and platelets that help your blood clot), bleeding, fever, neurologic symptoms (such as changes in level of alertness including coma, headache, difficulty  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
speaking confusion or paralysis) and kidney dysfunction. The symptoms are due to the formation of clots that form or spread to many organs. This can usually be treated with exchange plasmapheresis, a therapy that removes and replaces plasma the protein containing fluid from a patient's blood. Should you go on this trial, we will follow you closely for any signs or symptoms of this disease. - Leg weakness

Additional adverse effects could be related to the immune response to the PSA and/or TRICOM proteins that are part of the vaccines. Some normal human cells (such as normal prostate cells)
have these proteins on their surface. If the vaccine causes an immune reaction against these normal cells, you could develop swelling or inflammation of these tissues. While unlikely, it is also possible that if you develop a very active antibody (immune) reaction after the vaccination, you could develop an immune complex disease (or serum sickness) which can cause fevers, rashes, joint pains, and less commonly, kidney failure and severe allergic reaction inside blood vessels (vasculitis) or any part of your body. None of these symptoms have been observed to date in subjects receiving BNIT's vaccines, but the possibility of their occurrence exists.

Your study doctor will discuss the risks to unborn children for drugs other than prostvac that may be used in this study. The effects of prostvac, if any, on unborn children are unknown. If your partner is capable of becoming pregnant and you wish to participate in this study, and you have not had your prostate or testicles removed, or you are not receiving continuous hormone therapy, then you must use a medically acceptable method of birth control while you are receiving study vaccine and for a period of at least one month after your last dose of study vaccine. If your partner becomes pregnant during the course of treatment, you must inform your doctor immediately. Your doctor will ensure that you and your partner receive information about options available to you in relation to pregnancy and that you and your partner are fully supported in whichever option you chose. Acceptable birth control options for you and your partner include:  
- surgical sterilization (you and/or your partner) - approved hormonal contraceptives or therapies (such as birth control pills, Depo-Provera, or Lupron Depot)
- barrier methods (such as a condom or diaphragm) used with a spermicide
- an intrauterine device (IUD)  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent

The study treatment may involve risks to you that are currently unknown. Your cancer may not get better or may become worse while you are in this study. Risks from X-rays and / or Scans: Radiological testing, such as CT scans, MRIs, X-rays and/or radioactive drugs may be used to assess the treatment of your disease at various times during therapy. The cumulative radiation exposure from these tests is considered very small and is unlikely to adversely affect you or your disease. Because some of these tests require administration of contrast you could experience pain, bruising, and/or infection at the site of injection, or an allergic reaction to the contrast agent. Please notify the investigator if you know or suspect you are allergic to contrast dye.  
ECG: There are no significant risks or discomforts associated with an ECG. Some patches will be adhered to your skin that may cause some reddening or slight itching.  
Blood draws: There may be some side effects associated with the procedures for drawing blood in this study, but the person drawing your blood will attempt to minimize this discomfort. Side effects include pain and bruising in the area where the needle is inserted, lightheadedness, and rarely, fainting. When large amounts of blood are collected, low red blood cell count (anemia) is a risk.

The aim of this study is to see if this prostvac vaccine will cause your tumors to shrink. We do not know if you will receive personal medical benefit from taking part in this study. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not much information about the drug's effect on your cancer, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.
Clinical trial: NCT02649439
Section: Procedures
Subsections: Description Of Research Study What Will Happen If You **Take Part In This Research Study?** Before You Begin The Study

Certain standards (criteria) have been established to ensure that you are a medically appropriate candidate for this trial. These criteria also make sure that the results of this study can be used to help make decisions about treating other patients. We will record your medical history and give you a physical examination. You will undergo standard blood tests including a complete blood count, chemistry panel, and prostate-specific antigen (PSA) levels, and scans and x-rays as part of the NCI Screening Protocol. One test of your immune system will be a blood test that checks  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
for the presence of the human immunodeficiency virus (HIV), the cause of acquired immunodeficiency syndrome (AIDS). HIV infection may disqualify you from this study. If you test positive for HIV, we will tell you what the results mean, how to find care, how to avoid infecting others, how we report newly diagnosed HIV infection. We will do other blood tests to look for infection with hepatitis B and C. If these tests are positive, you will not be eligible to participate in the study because of the potential harm the vaccine may cause. Altogether, these tests will require about 100 cc (6 to 7 tablespoons) of blood.
Clinical trial: NCT02649439
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

Androgen deprivation therapy (ADT) and close clinical monitoring are one standard therapy option for prostate cancer patients who have biochemical progression (rise in PSA) after local radiation or surgery therapy. This group of patients is also referred to as non-metastatic castration sensitive prostate cancer (nmCSPC) or as biochemical recurrent prostate cancer. Another approach is monitoring of patients and their PSA values over time.  
PATIENT IDENTIFICATION CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH **STUDY**  
- Adult Patient or - Parent, for Minor Patient  
NIH-2514-1 (07-09)  
P.A.: 09-25-0099 File in Section 4: Protocol Consent (1)  
This study is being done to determine if an immunotherapy vaccine product called prostvac can decrease tumor growth rate as measured by PSA compared to a group getting surveillance alone. Clinical development of prostvac is based on the idea that the immune system (group of cells and organs in the body that recognize and fight infection) can be taught to find and kill certain cancer cells, in this case prostate cancer cells. This is an investigational vaccine regimen, which means that it is not yet approved by health authorities and can be used only in a research study. In September of 2017, it was reported that a large (phase III) study of PROSTVAC alone did not show that this treatment could improve survival in advanced prostate cancer. However, the scientific reasoning to use Prostvac in earlier stage prostate cancer remains sound and this study will continue. Furthermore, at this point neither this trial or the phase III trial have suggested a safety concern for PROSTVAC. In this study, patients will be randomly assigned to either one of two main study groups. One group will receive prostvac for 6 months and the other group will closely be monitored (surveillance) for 6 months then receive prostvac for 6 months. Your treatment is determined by a randomization process (chosen as if by the flip of a coin). Random assignment will be done with the help of a computer and patients will be informed on the day of their start about their respective group. You have an equal chance of being randomized to any of the two groups.
Clinical trial: NCT02649439
Section: Voluntary Participation
Subsections: Why Are You Being Asked To Take Part In This Study?

You are being asked to participate in this study for three reasons: 1) You had received local therapy for prostate cancer and now your PSA is rising 2) You do not have tumor anywhere else in the body that can be seen on standard imaging 3) you have normal levels of testosterone (greater than 100 ng/dl), all of which indicate that you have nmCSPC or biochemical recurrence
Clinical trial: NCT02649439
Section: Withdrawal from Study
Subsections: When You **Are Finished Taking The Drugs (Treatment)**|After I **Stop The Study**|Stopping Therapy

When you stop the prostvac vaccine, we will ask you to return to NIH for follow-up clinic visits at least every 1 month until you recover from any side effects and/or your cancer worsens. At these visits you will have exams, tests and procedures that are part of regular cancer care, including physical exam, and standard blood tests. Bone scan will be done at baseline, every 6 months for a year, and as needed. You will have CT scan of the chest, abdomen, and pelvis or MRI and bone scan every 6 months for a year, and as needed. You will continue to be followed after until progression or ADT is clinically indicated. When you develop evidence of disease progression by the scans or other clinical findings, or when your study doctor thinks that your participation in this study is detrimental to your health due to your other medical conditions or due to the study drugs, or when you want to withdraw from the study, you will be taken off study drugs and taken off this study. At that time, you will be evaluated by a physician with physical and examination and labs.

You may have the option to take part in a PET imaging study at the NCI in Bethesda, MD, which the study team can go over with you. The PET imaging study may utilize relevant data collected from you on this study. A separate consent form will be provided to you at that time for you to grant permission to take part in the PET imaging study.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
Risks or Discomforts of Participation What side effects or risks can I expect **from being in this study?** Risks to be considered with prostvac

You will continue to receive therapy and medical follow-up until:  
- The study is completed; - You decide that you no longer wish to participate in the study; - You experience unacceptable side effects; - Your cancer gets worse;
- You need to start another kind of therapy (called androgen deprivation therapy) for your cancer
- The doctor feels that it is unsafe for you to continue;  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
- New information becomes available that suggests another treatment would be better for you; or
- The study is stopped.
You can stop taking part in the study at any time. However, if you are thinking about dropping out of the study, please tell your research team so they can tell you how to end your participation safely. 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 Bavarian Nordic, Inc. or 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.