Clinical trial: NCT02362451
Section: Alternatives
Subsections: Alternative Approaches Or Treatments What Other Choices Do I Have If I Do Not Take Part In This Study?

Treatment options for patients with elevated PSA levels but no evidence of disease spread to other organs following primary treatment for their prostate cancer includes watchful waiting or androgen deprivation hormone therapy. However, it is unclear for patients with this stage of disease (Stage D0) what the best approach is. Because many patients prefer to avoid the side effects of hormonal treatment (impotence, hot flashes, loss of libido, breast tenderness, osteoporosis and bone fractures) watchful waiting is often chosen. File in Section 4: Protocol Consent (1) Version Date: 12/18/2019 Page 6 of 12 CC ICF template v. 09.27.19 If you develop evidence of disease progression, involving spread of your prostate cancer to the bone, brain or other organs, alternative treatments/therapy for your cancer may include:  
Getting treatment or care for your cancer without being in a study. Some examples include: treatment with hormone therapy, radiotherapy, chemotherapy or a combination of these approaches.  
Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.  
Taking part in another study. No further therapy at all.
Please discuss these options with your doctor.
Clinical trial: NCT02362451
Section: Confidentiality
Subsections: Confidentiality Protections Provided In This Study Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality|Privacy Act

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).  
Qualified representatives from PDS Biotechnology and RareCyte, Inc., companies that will supply agents used to perform studies on your cells.
When results of an NIH research study are reported in medical journals or at scientific meetings, the people who take part are not named and identified. In most cases, the NIH will not release any information about your research involvement without your written permission. However, if you sign a release of information form, for example, for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens or data. You should be aware that there is a slight possibility that someone could figure out the information is about you. 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. 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: NCT02362451
Section: Duration of Study Involvement
Subsections: How Many People Will Take Part In This Study?|During The Study|After The Study

A maximum of 75 total patients could be accrued to this study. The initial accrual for this study will include a cohort of 6 patients to determine the preliminary safety of the multi-epitope (ME) TARP peptide vaccine. Once this preliminary safety is established, patients that subsequently enroll in the study will be randomized to receive either the ME TARP peptide autologous dendritic cell vaccine or an autologous elutriated monocyte placebo vaccine. Autologous means that the cells used to manufacture either the ME TARP dendritic cell vaccine or the elutriated monocyte placebo vaccine come from you (as opposed to cells from a related or unrelated donor).

With each clinic visit you will have a physical exam, laboratory and research blood draws. You will be asked about any side effects or illnesses you may have had between visits. You will also be asked about your medications. We will continue to monitor your PSA and calculate your PSA doubling time. You will continue to monitor your injection site and bring your Vaccine Report Card to your visits.

After you have completed the study, you will be contacted by phone, mail or through your local oncologist every year to see how you are doing for the rest of your life.
Clinical trial: NCT02362451
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect From Being In This Study?|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?|Will Taking Part In This Research Study Cost You Anything?|Policy Regarding Research-Related Injuries

Everyone taking part in the study will be monitored very carefully for any side effects and we will ask you to fill out a Vaccine Report Card to monitor any symptoms you may have following your vaccine injection. Since we don't know all the side effects that may be associated with these File in Section 4: Protocol Consent (1) Version Date: 12/18/2019 Page 5 of 12 CC ICF template v. 09.27.19 vaccines, it is very important that you report any changes that you may notice, even if your study team does not specifically ask about them. In the NCI 09-C-0139 TARP vaccine study, the main side effects were limited to local injection site reactions that generally lasted about 5-7 days or less. The second generation ME TARP vaccine platform with multiple peptides that is being investigated in this study may result in more potent immune response with potentially more unexpected and unknown side effects such as:  
Fever Chills Rash Flu-like symptoms Headache Likely Injection site reactions, including possible pain or soreness, swelling, itching, and/or redness at the injection site.  
Less Likely It is possible that you could develop an immune response to the TARP peptide that will cause inflammation in your prostate gland if it was not taken out as part of the initial primary treatment for your prostate cancer. We did not observe this kind of inflammation in any of the men that received the TARP vaccine in the 09-C-0139 NCI study.  
More potent immune responses could also be associated with auto-immunity and inflammation of the thyroid gland. Although this was not observed in the 09C-0139 NCI study, your thyroid function will be monitored as part of this study.

Taking part in this study may or may not provide a direct benefit to you. It is unknown whether vaccination with ME-TARP DCs will stimulate an immune response by your body. Since this is an experimental therapy, no benefit can be promised. However, the information we obtain from both the laboratory studies and your response to vaccination may also allow us to advance the understanding and treatment of cancer vaccines for future patients.

NIH does not bill health insurance companies or participants for any research or related clinical care that you receive at the NIH Clinical Center.  
If some tests and procedures performed outside the NIH Clinical Center, 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 NIH Clinical Center.  
Once you have completed taking part in the study, medical care will no longer be provided by the NIH Clinical Center.

The NIH Clinical Center will provide short-term medical care for any injury resulting from your participation in research here. In general, no long-term medical care or financial compensation for research-related injuries will be provided by the NIH, the NIH Clinical Center, or the Federal  
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Government. However, you have the right to pursue legal remedy if you believe that your injury justifies such action.
Clinical trial: NCT02362451
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study?|What Happens Next?

Before you begin the study you will need to have the screening examinations, tests or procedures to find out if you can be in the study. Some of these examinations, test or procedures may be repeated during the study to assure your safety and to assess your responses vaccination. Some of these screening tests may also be performed at your outside home institution. The examinations, tests, and procedures that are a part of the screening process include:  
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Laboratory blood test such as CBC, Chemistries, Mineral, Hepatic, Acute Panel urinalysis and Thyroid Function Tests HLA, Lymphocyte subsets, PT/PTT, Amylase, Lipase, Lipid panel, PSA, TTV Viral screen, VDRL, Type and Cross As part of this study, we will test you for infection with the human immunodeficiency virus
(HIV), the virus that causes AIDS. If you are infected with HIV you will not be able to participate in this study. We will tell you what the results mean, how to find care, how to avoid infecting others, how we report HIV infection, and the importance of informing your partners at possible risk because of your HIV infection.  
CT scan Bone scan Physical exam with past medical history Confirmation of prostate cancer You will be asked to read and sign the informed consent, if we determine from screening that:  
You have met all eligibility criteria You have prostate cancer and an elevated or increasing PSA level following completion of primary treatment for your cancer.  
You have no evidence that the prostate cancer has spread to other organs in your body. You are not currently receiving androgen deprivation hormone therapy (prior therapy is allowed).  
You have a PSA doubling time (PSADT) between 3 and 15 months. You understand the informed consent

After you have been found eligible for the study, and you have signed the informed consent for this study you will be scheduled for an apheresis. Both Arm A and B will go through a 15-liter apheresis procedure. A large number of cells are required to ensure that we have sufficient cells to make your vaccines, whether you are receiving the active ME TARP vaccine or the inactive elutriated monocyte placebo vaccine. These cells are collected during the apheresis procedure. For those patients assigned to receive the elutriated monocyte inactive placebo vaccine, these cells would be available to make active vaccine in the event that significant slowing in PSA velocity is documented to occur with the active ME TARP dendritic cell vaccine. A description of the apheresis procedure is below. Apheresis may be required to be repeated during study participation if not enough cells have initially been obtained.
Clinical trial: NCT02362451
Section: Purpose of Research
Subsections: File In Section 4: Protocol Consent (1) Version Date: 12/18/2019 Page 1 Of 12 Cc Icf Template V. 09.27.19 Why Is This Study Being Done?|Description Of Research Study This Is A Phase Ii Clinical Trial.

Research has shown that men who continue to have an elevated or rising prostate specific antigen (PSA) level following their primary treatment for prostate cancer are at increased risk for their cancer to progress. PSA is a protein found on normal and cancerous prostate cells. PSA levels are used to identify men who are at increased risk for prostate cancer, to monitor disease progression, or to monitor responses to treatment. The time it takes for the prostate cancer to progress can be highly variable- from months to many years. One measure that has been shown in studies to be accurate in predicting how quickly someone is likely to progress is based on the change in PSA levels over time. This is called the "**PSA doubling time**" (PSADT). Individuals that have a PSADT less than 3 months are more likely to experience disease progression, have lower survival rates and are not eligible for this study. In contrast, individuals that have a slow PSADT of greater than 15 months have an extremely low risk of death from prostate cancer; they are also not eligible for this study.

It is a blinded, prospective, randomized placebo-controlled study. Blinded means that you will not know whether you have been assigned to receive the active ME TARP vaccine or the inactive placebo vaccine. Both vaccines are made using immune cells collected from your own body. Randomized means that whether you are assigned to receive the active ME TARP vaccine or the inactive placebo vaccine occurs strictly by chance. This study involves a 2:1 randomization. The 2:1 randomization means that you have a two in three chance of being randomly selected to receive the active ME TARP vaccine instead of the placebo. The randomization assignment is generated by a computer and is not controlled by the Principal Investigator or any members of the protocol File in Section 4: Protocol Consent (1) Version Date: 12/18/2019 Page 2 of 12 CC ICF template v. 09.27.19 research team. A placebo control is being used in this study because we are trying to determine if the responses we observed to the first TARP vaccine we tested can be confirmed. The study is 96 weeks in duration. Arm A: 44 patients will receive active, autologous ME TARP peptide DC vaccine Arm B: 22 patients will receive *inactive*, autologous elutriated monocyte placebo vaccine Vaccines will be administered intradermally (just under the top layer of the skin) at Weeks 3, 6, 9, 12, 15, and 24. See Study Chart.
Clinical trial: NCT02362451
Section: Voluntary Participation
Subsections: It Is Your Choice To Take Part In The Study|Why Are You Being Asked To Take Part In This Study?|Consent Document

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.

We invite you to participate in this research study because you have D0 Prostate Cancer. D0 disease means that you continue to have elevated or rising levels of prostate specific antigen (PSA) in your blood following your initial treatment for your prostate cancer, even though there is no evidence that the prostate cancer has spread (or metastasized) to other organs in your body. Your PSADT is between 3 and 15 months, and you have met the eligibility criteria.

Please keep a copy of this document in case you want to read it again. File in Section 4: Protocol Consent (1) Version Date: 12/18/2019 Page 11 of 12 CC ICF template v. 09.27.19 Adult Research Participant: I have read the explanation about this study and have been given the opportunity to discuss it and to ask questions. I consent to participate in this study. Signature of Research Participant Print Name of Research Participant Date Legally Authorized Representative (LAR) for an Adult Unable to Consent: I have read the explanation about this study and have been given the opportunity to discuss it and to ask questions. I am legally authorized to make research decisions on behalf of the adult participant unable to consent and have the authority to provide consent to this study. As applicable, the information in the above consent was described to the adult participant unable to consent who agrees to participate in the study. Signature of LAR Print Name of LAR Date Investigator: Signature of Investigator Print Name of Investigator Date Witness to the oral short-form consent process only: This section is only required if you are doing the oral short-consent process and this English consent form has been approved by the IRB for use as the basis of translation. Witness: Signature of Witness* Print Name of Witness Date
Clinical trial: NCT02362451
Section: Withdrawal from Study
Subsections: Stopping Therapy

Your doctor may decide to stop your therapy for the following reasons: - if you your vaccine is delayed for more than 6 weeks - if your disease comes back during treatment - if you have side effects from the treatment that your doctor thinks are too severe - if he/she decides to end the study 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. 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.