Clinical trial: NCT02649855
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 (ADT alone or ADT with chemotherapy)
.  
Observation only, where your doctor, depending on his clinical judgment and your opinion, follows your PSA and watches you for cancer recurrence.
.  
In June of 2017, new data indicated that an oral hormone therapy that is FDA approved for prostate cancer (abiraterone) can also be taken daily with ADT and improve survival compared to ADT alone.  The best comparisons at this time suggest that this daily treatment may be equivalent to the 6 infusions of docetaxel chemotherapy.
Please talk to your doctor about these and other options.
Clinical trial: NCT02649855
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.  
| 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 |
Clinical trial: NCT02649855
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Risks Or Side Effects Can I Expect From The Fowlpox Vaccine?|Docetaxel Risks Common, Some May Be Serious|Other Risks|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?|Research Radiation Risks:

Side effects from fowlpox are mild and could include injection site reactions, fever, fatigue (feeling very tired), anemia (low red blood cell count) and leucopenia (low white blood cell count). With any experimental treatment, there is the risk of unexpected and serious or deadly complications even if they have not been seen previously.  
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 |  
  
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In 100 people receiving Docetaxel, more than 20 and up to 100 may have:
- Swelling of the body
- Hair loss
- Change in nails - Rash, itching
- Vomiting, diarrhea, nausea
- Sores in mouth which may cause difficulty swallowing
- Infection, especially when white blood cell count is low - Anemia which may require blood transfusions
- Tiredness - Numbness and tingling of the arms and legs
- Fever
- Swelling and redness of the arms, leg or face
- Pain - Watering, itchy eyes  
| 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 |  
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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 ulikely 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.  
EG: 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.  
| PATIENT IDENTIFICATION   |
|--------------------------|  
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  
| 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 |  
  
STUDY NUMBER:   16-C-0048 CONTINUATION: page 13 of 19 pages 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.

This research study may involve exposure to radiation from a low dose CT with NaF PET scan at baseline and every 12 months until progression or at progression.  This radiation exposure is not required for your medical care and is for research purposes only. From participating in this, the total amount of radiation you will receive is 1.2 rem which is below the guideline of 5.0 rem per year allowed for research subjects by the NIH Radiation Safety Committee.  The average person in the United States receives a radiation exposure of 0.3 rem per year from natural sources, such as the sun, outer space, and the earth's air and soil.  If you would like more information about radiation, please ask the investigator for a copy of the pamphlet, An Introduction to Radiation for NIH Research Subjects.  
While there is no direct evidence that the amount of exposure received from participating in this study is harmful, there is indirect evidence it may not be completely safe.  There may be a very slight increase in the risk of cancer. Please tell your doctor if you have had any radiation exposure in the past year, either from other research studies or from medical tests or care, so we can make sure that you will not receive too much radiation. Radiation exposure includes x-rays taken in radiology departments, cardiac catheterization, and fluoroscopy as well as nuclear medicine scans in which radioactive materials were injected into your body.  
CONTINUATION SHEET for either:
NIH-2514-1 (07-09)
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Clinical trial: NCT02649855
Section: Procedures
Subsections: Description Of Research Study What Will Happen If You Take Part In This Research Study? Before You Begin The Study|Research Blood Samples|Tumor Biopsy (Optional)|Optional Imaging

You will need to have a physical exam, blood tests and scans to find out if you can be in the study. The exams and tests are part of regular cancer care and may be done even if you do not join the study. However, there are some extra exams, tests and procedures that you will need to have if you take part in this study. If you had some of the tests recently, they may not need to be repeated.  The following is a list of what we need to make sure you can do this study:
.  
Medical history and physical exam.  
Blood tests including a complete blood count, chemistry panel, and prostate-specific antigen
.  
(PSA) levels.  
Electrocardiogram (ECG)
.  
Scans or other imaging studies
.  
Human immunodeficiency virus (HIV) test.  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.  
Hepatitis B and C.  If these tests are positive, you will not be eligible to participate in the
.  
study because there is a possibility the vaccine may harm you.
Altogether, these tests will require about 100 ml (6 to 7 tablespoons) of blood.  
| 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 |

An important part of this study is testing the effects of this treatment on your tumor and immune system.  Research tests will be done on blood taken at different times during the study.  The NIH
has set a limit on the maximum amount of blood that can be taken for research. This limit is based on your age.  For adults, no more than 37 tablespoons can be taken over an 8-week period. All patients who join the study will have blood samples drawn for pharmacokinetic (PK) studies. PK studies try to find out how the body affects the drug after it has been given to a person.  We will do this study with the first docetaxel treatment.  We will collect the blood before you start your initial infusion of docetaxel, about 5 minutes before the docetaxel infusion ends, 15 minutes, 30 minutes, 3 hours, 6 hours, 12 hours and 24 hours after the end of the docetaxel infusion.  We will need to admit you into the hospital to make it easier on you to collect the sample.  We will insert two IV lines (one in each arm).  One IV line is for the chemotherapy infusion, the other IV
line is for the blood collection.  
In addition, we may at various time points during the study, collect blood samples to study your immune system (group of cells and organs in the body that recognize and fight infection).  The samples we collect will help us better understand how the vaccine works inside the human body.  
The samples are for research purposes only.

We would like to collect tumor samples by doing biopsies at two time points during the study
(before you begin treatment and after you receive 2 cycles of vaccine therapy).  For patients in Arm C it will be before you start vaccine and after vaccine is completed its full course.  These biopsies will help us evaluate immune changes within the tumor.  The decision for a biopsy will be based on the level of risk.  The biopsy procedure usually causes only brief discomfort at the site from which the biopsy is taken.  Rarely, infection or bleeding may occur at the needle site.  
| 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 |  
  
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Another way to monitor your tumor for any signs that your cancer is recurring or getting worse is with an endorectal MRI (an MRI image taken from inside the rectum) and Sodium Fluoride
(NaF) PET scans. These scans will be done at baseline and, every 12 months until progression or and then at progression.  
These scans to be performed are exclusively for research purposes and will not benefit you.  It might help other people in the future.  Even if you decide to have the scans you can change your mind at any time.  The decision to participate in this part of the research is optional, and no matter what you decide to do, it will not affect your care.  
| 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 |  
  
STUDY NUMBER:   16-C-0048 CONTINUATION: page 17 of 19 pages You will be given the opportunity to decide whether you want to participate at the time of the procedure.
Clinical trial: NCT02649855
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

Recently a clinical study showed that adding chemotherapy (docetaxel) for six infusions significantly extended the lives of men compared to those who were only treated with ADT alone. This study is being done to determine if combining a vaccine called PROSTVAC and the chemotherapy docetaxel along with androgen deprivation therapy (ADT) will work better.  
Clinical work with 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 a new vaccine treatment, which means that it is not approved for use on the general public and can only be used 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. (A phase III study is designed to lead to FDA approval and standard use of a therapy if the findings are positive.)  The preliminary findings of the study suggest that PROSTVAC alone did not have an impact (positive or negative)
on overall survival of patients treated.  All patients had a similar length of survival regardless of treatment with vaccine alone or no treatment. However, the scientific reasoning to combine PROSTVAC with standard use docetaxel remains sound, and this study will continue. Furthermore, at this point neither this trial nor the phase III trial have suggested a safety concern for PROSTVAC.  
In this study, you will be assigned to Arm C if you are a patient who has not started ADT or a patient who has started on ADT within the last 28 days.  Otherwise, your treatment group (Arm A
or Arm B) will be decided 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 you will be told on the day you start about your assigned group. You have an equal chance of being randomized to any of the two groups..  If you are randomized to Arm A, you will receive ADT for at least 28 days followed by docetaxel and then a vaccine called PROSTVAC.  If you are in Arm B, you will receive ADT for at least 28 dys followed by PROSTVAC and docetaxel, given 20-48 hours apart.  If you are in Arm C, you will receive ADT for less than or equal to 28 days followed by PROSTVAC.  After the vaccine treatment course is complete, the docetaxel course will be begin within 28 days of the last vaccine given.  
It is important to note that in the clinical study that showed chemotherapy with ADT improved survival, the greatest benefit was seen in men with high volume disease (disease in more than 4 spots in the bones, including areas beyond the spine and pelvis, or disease in an organ).  For patients with low volume disease (less than 4 areas in the bones, not beyond the ribs or pelvis, or not in an organ) the data is less clear. It appears with longer follow up there may not be a clear benefit of the chemotherapy in terms of overall survival (based on new data presented in the Fall PATIENT IDENTIFICATION
CONTINUATION SHEET for either:
NIH-2514-1 (07-09)  
  
CONTINUATION: page 3 of 19 pages Statistically speaking, this is not a perfect analysis and thus questions remain.  
of 2016).  
Nonetheless, this treatment seems to be an appropriate option for "low volume" patients since patients with low volume of disease were eligible for the study which showed a benefit overall. Also, the treatment is well tolerated because more than 86% of the patients who started chemotherapy received all 6 infusions. The primary investigator or an associate investigator will discuss specifically how your disease relates to the data that is available.  We also encourage you to discuss enrollment in this clinical trial with your primary oncologist to get a second opinion. For Arm C participants, chemotherapy will begin within 4 months of starting ADT and possibly sooner, depending on your disease.  This trial was designed to remain consistent with the data this study is based on.
Clinical trial: NCT02649855
Section: Withdrawal from Study
Subsections: Stopping Therapy

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;
•  
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 destroved 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.