Clinical trial: NCT03261336
Section: Alternatives
Subsections: What If I Am Already Participating In Another Study?

Are you already participating in any other research studies? Yes  No If yes, please state which study (ies) _______________________________________________ While participating in this study, you may not take part in any other research study without approval from the principal investigator.
Clinical trial: NCT03261336
Section: Confidentiality
Subsections: Will My Medical Information Be Kept Private?|Authorization To Use And Disclose Information For Research Purposes|What Protected Health Information About Me Will Be Used Or Disclosed As Part Of This Research?

We will keep your records private to the amount allowed by law. Research are **stored and kept** according to legal requirements. You will not be identified in any reports or publications about this study. However, certain people and groups will have access to your research **and medical** records. The sponsor of the study will look at your research and medical records. The Inova Health System Institutional Review Board (IRB) and federal and state agencies that have authority over the study may look at your research records. Members of the study staff will also have access to your research records. Additional groups, which are explained in the authorization section beginning on page 7, may also have access to these records.

This authorization form will explain how health information about you will be used, protected, and disclosed (shared). In addition, you will receive a summary of Inova Health System's "Notice of Privacy Practices". If the study requires you to have follow-up visits in the investigators' private practice office, you should ask for a copy of his/her "Notice **of Privacy** Practices" at the time of your visit. If you agree to participate in the research, and authorize the use and disclosure of your medical information for research purposes, please sign this **form. If** you choose not to authorize the use and disclosure of your health information you may not participate in the research study.

You will be asked about your health information that is relevant to the study. In addition, your non-research medical records will be reviewed and researchers may need to discuss your health information with your treating doctor(s), if applicable. Researchers will also collect new information about you as a result of the research tests, procedures, visits and/or questionnaires/interviews. This collected information constitutes and is called your "Research Record".
Clinical trial: NCT03261336
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?

If you decide to participate, you will be in this study for up to one year or until disease progression (if sooner than one year) and you may be in long term follow up for up to five years. If the treatment is still working at one year your doctor may discuss whether continuing calcitriol treatment is recommended but you will no longer receive calcitriol as part of this study. What will happen if I take part in this research study? Starting on day 1 and continuing throughout the study you will receive the following drugs:  
1.) Calcitriol will be taken by mouth, three days, each week (Monday, Tuesday, and Wednesday). The daily dose will be 10mcg (20 tablets).  
2.) Ketoconazole will be taken by mouth, three times, every day. Each dose will be 400mg (2 tablets) for a total daily dose of 1200mg (6 tablets).  
3.) Beginning the day before the first dose of calcitriol, hydrocortisone will be taken by mouth every day throughout the study, 2 times a day. The dose will be 20mg (2 tablets) in the morning and 10mg (1 tablet) in the evening. The total daily dose is 30mg. Hydrocortisone is given to protect your adrenal glands from the effects of the ketoconazole (ketoconazole may reduce the amount of hormone released by your adrenal glands).
A prior study determined that 10 mcg of calcitriol is the maximum safe dose that **can be given** with standard doses of ketoconazole + hydrocortisone. Ketoconazole and hydrocortisone are standardly used in the treatment of men with prostate cancer such as yours; calcitriol is used in routine practice to treat vitamin D deficiency, vitamin D deficiency associated with chronic renal failure and has been used to treat cancer in prior studies at doses up to 38 micrograms per day for 3 days every week has been given without any toxicity. However, only limited **clinical** experience is available on the use of these 3 drugs together.  
RESEARCH CONSENT  
Date Approved: September 11, 2017 Inova IRB: C.F. Bonds-Beeken, IRB Coordinator IRB File \# 16-2200 The following is a schedule of the treatments you will take and the procedures in which you will participate if you enroll in this study:
Schedule Calcitriol 10mcg 3days a week; Ketoconazole 400mg 3 times a day; Hydrocortisone 2 times a day 20mg AM, 10mg PM  
| Day             | -1   | 1   | 2   | 3   | 4   | 5   | 6   | 7   | 8   | 9   | 10   | 11   | 12   | 13   | 14   | 15   | 16   | 17   | 18   | 19   | 20   | 21   | 22   | 23   | 24   | 25   | 26   | 27   | 28   | 1   |
|-----------------|------|-----|-----|-----|-----|-----|-----|-----|-----|-----|------|------|------|------|------|------|------|------|------|------|------|------|------|------|------|------|------|------|------|-----|
| Calcitriol      | C    | C   | C   | C   | C   | C   | C   | C   | C   | C   | C    | C    | C    |      |      |      |      |      |      |      |      |      |      |      |      |      |      |      |      |     |
| Keto conazole   | K    | K   | K   | K   | K   | K   | K   | K   | K   | K   | K    | K    | K    | K    | K    | K    | K    | K    | K    | K    | K    | K    | K    | K    | K    | K    | K    | K    | K    |     |
| Hydro cortisone | H    | H   | H   | H   | H   | H   | H   | H   | H   | H   | H    | H    | H    | H    | H    | H    | H    | H    | H    | H    | H    | H    | H    | H    | H    | H    | H    | H    | H    | H   |  
Top row in table reflects days of treatment, starting Day 1 of therapy. K = ketoconazole 400 mg TID (1200mg/day). C = Calcitriol 10 mcg three days a week (e.g. Monday, Tuesday, and Wednesday) H =Hydrocortisone 20mg AM, 10mg PM (starting in the evening before the first dose of calcitriol)
If you take part in the study, you will have the following tests and procedures: Procedures that are part of regular cancer care and may be done even if you do not join the study: These are procedures that would be done as part of the standard of care of patients with **cancer** that are being treated with a chemotherapeutic regimen outside a study setting. This includes procedures such as:  
- CAT scans (computerized pictures of your body with or without a dye injected into **your**
vein) to determine the amount of cancer in your body.  
- **Other types of x-rays or MRI (pictures of your body that depend on magnetic fields) may**
be done in special situations to determine the amount or size of tumor in your body. These pictures can be taken between 6-12 weeks and will help determine if your tumor is growing, shrinking, or maintaining its previous size. All such studies are part of the regular and routine assessment of the status of the cancer in your body and are not done solely for research purposes.  
- **A full physical and history will be done before treatment and then every 4 weeks.** - **Blood tests including a complete blood count (to determine your ability to fight**
infections, presence and severity of anemia, and risk for bleeding) and liver and **kidney** will be done on a monthly basis. Blood will be drawn using a needle and a syringe from a vein in your arm or a port or central line if you have one (a catheter that has been previously inserted through a large vein to facilitate blood draws and medication administration). The equivalent of 1 tablespoon will be drawn on a weekly basis.
Other than taking the study drug combination there are no special procedures being done because you are enrolled in this study. You will be asked to complete a daily diary that tracks the medications you are taking in this study.
Clinical trial: NCT03261336
Section: Participant's Rights
Subsections: What Are My Rights If I Take Part In This Study?|How Can I Take Back My Authorization?|Will I Have Access To The Information In My Research Record?

Taking part in this study is your choice. No matter what decision you make, and even **if your**
decision changes, there will be no penalty to you. You will not lose medical care or **any legal**
rights. A member of your research team will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. If you would like more information about your rights as a participant in a research study, contact: Inova Health System Institutional Review Board (IRB) at (703) 776-3167. The Inova Health System IRB may contact you by mail or telephone to find out if you were satisfied with your study participation.

You may take back your authorization at any time by sending a written request to Donald Trump, MD, 8505 Arlington Blvd, Suite 100, Fairfax, VA 22031. If you take back your authorization, your participation in the study will end and no further private health information will be acquired. The study staff may keep or disclose information obtained before you took back your authorization in order to preserve the scientific integrity of the **study.** If you choose not to authorize the use and disclosure of your health information or withdraw from the study, you will continue to have access to medical care at Inova Health **System and** IMG Hematology and Oncology.

While the study is in progress, your access to your Research Record will be temporarily limited to ensure proper evaluation of the research study results. You will continue to have access to your non-research medical record during the study. You will be able to see your **Research** Record when the research is completed. You have the right to see and copy the medical information that is collected from you during the study and kept by the Inova Health System. You will have that right for so long as that information is maintained by the study **staff and the** other entities that are subject to federal privacy regulations. This does not include information about the study itself, such as protocols, which may otherwise be confidential, and which does not relate to an individual subject.
Clinical trial: NCT03261336
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Risks Can I Expect From Taking Part In This Study?|Are There Reproductive Risks While On This Study?|Are There Benefits To Taking Part 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
- **Be asked sensitive or private questions which you normally do not discuss**
- **The most important non-medical risk is the disclosure of your protected health**
information (PHI). PHI is any health information that is collected about **you, including** your history and new information collected during this study. You will have an opportunity to review the ways in which your PHI may be used and disclosed in the authorization section of this form that begins on page 7.
There is also a risk that you could have side effects.  
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.  
- **Some side effects may interfere with your ability to have children.**
- **Some side effects may be serious and may even result in death.**
Here are important points about how you and the study doctor can make side effects less of a problem:
- **Tell the study doctor if you notice or feel anything different so they can see if you are**
having a side effect.  
- **The study doctor may be able to treat some side effects.**

This study may involve risks to you or your unborn child that are not known at this time therefore you should not father a baby while on this study. Male patients must use an effective method of birth control, such as condoms with spermicide, abstinence or have had a vasectomy, when participating in this study and should continue **use of** birth control for three months after receiving the last dose of the drug to be sure that the drug has cleared from the body. Males who are receiving treatment should not donate sperm for **at least** three months after the study is completed. Discuss birth control measures with your **doctor.**

Taking part in this study may or may not make your health better. We hope the information learned from this study will benefit others in the future. It is not known if this treatment will help you or not. Possible help may include shrinkage or disappearance of your cancer. This would result in a decrease in your symptoms and improvement in your quality of life. It is also possible that the investigational **treatments may** prove to be less useful or even harmful to you. You understand that no guarantee of help can be made to you for taking part in this research study. Future patients may be helped from the results and information gained from this study.
Clinical trial: NCT03261336
Section: Purpose of Research
Subsections: Informed Consent For A Research Study|Why Is This Study Being Done?

Study Title: **A Phase II Study of Oral Calcitriol in Combination with Ketoconazole in**
Androgen Independent Prostate Cancer Sponsor: **Inova Schar Cancer Institute** Principal Investigator: **Donald Trump, MD** Site of Investigation: **IMG Hematology and Oncology**
8505 Arlington Blvd, Suite 100 Fairfax, VA 22031 IMG Hematology and Oncology 8501 Arlington Blvd, Suite 340 Fairfax, VA 22031

This study is being done to determine how therapy with calcitriol in combination with the drug ketoconazole and the drug hydrocortisone will affect PSA levels in men with prostate cancer who have progressed while receiving abiraterone (Zytiga). Calcitriol is the most active form of vitamin D and is naturally produced in our bodies. In this study calcitriol will be given by mouth. Ketoconazole is a drug that is available in pill form. Ketoconazole is approved by the Food and Drug Administration (FDA) for the treatment of infections caused by fungus. The side effects of ketoconazole, when used alone, are **well known.** We also know that ketoconazole changes how the body breaks down other drugs. Ketoconazole blocks several chemicals in the human body that are important in breaking down drugs **like** calcitriol. This could result in higher and more prolonged amounts of calcitriol **in the blood and** in tumor or other tissues. This may improve the antitumor effects of calcitriol, but may also result in more unknown toxicities. Hydrocortisone is a steroid that is often used to decrease inflammation and treat conditions such as allergic reactions or over activity of the immune system such as asthma. This study is being done because laboratory and limited clinical studies suggest that **calcitriol has** the ability to slow or stop cancer growth. These studies were done on cancer tissue grown either artificially or in mice. Clinical studies have been done in humans which also indicate that calcitriol has anticancer effects. Work in the laboratory has shown that the addition of ketoconazole to calcitriol enhances its effects against the growth of tumors; **the administration of** these agents together may result in stronger inhibition of tumor growth. This study will attempt to determine if this drug combination will affect your prostate cancer.
Clinical trial: NCT03261336
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?

Yes. You can decide to stop at any time. It is important to tell the study doctor **if you are thinking** about stopping so any risks from the calcitriol, ketoconazole and/or hydrocortizone can be evaluated by your doctor. Another reason to tell your doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely and will work with you to obtain a written confirmation of your decision to revoke your authorization.  
Your participation can also be stopped without your approval by any of the following:
- **the study doctor** - **the Institutional Review Board (IRB - hospital committee that reviews and approves**
research)
Your doctor may decide to take you off this study if 1) your cancer progresses despite study treatment; 2) you develop an illness that prevents further administration of treatment; 3) you develop unacceptable side effects; 4) you decide to withdraw from the study; or 5) the **doctor** believes that your condition is unacceptable for further treatment.