Clinical trial: NCT03770455
Section: Alternatives
Subsections: What Alternatives Are There?

If you should decide not to participate in, or if you withdraw from this study, the study doctor can recommend other treatments. Alternative treatments for your cancer include:
A marketed drug or treatment with a different drug Other clinical trials Alternative hormonal therapy Chemotherapy If you decide you don't want any more active treatment, one of your options is "comfort care".  
Comfort care includes pain medication and other support. It aims to maintain your comfort and dignity rather than cure disease. Usually this care can be provided at home.  
If you have questions about alternate treatments and their potential benefits and risks, ask the study doctor for additional information. You do not need to participate in this study to be treated for your advanced cancer.
Clinical trial: NCT03770455
Section: Confidentiality
Subsections: Breach Of Confidentiality:|How Will My Personal Information Be Protected?

In addition, there is a low risk of breach of confidentiality associated with the study, however personal identifiers will be replaced with a code and access to the data will be only by those who are authorized to access. Methods to prevent a breach of confidentiality are listed later in the form under "How will my personal information be protected?".

If you decide to be in this study, the study doctor and research team will use health data about you to conduct this study, as described in this consent document. This may include your name, address, phone number, medical history, photographs, date of birth, and information from your study visits. This health data may come from your family doctor or other health care workers. It is the intent of the Sponsor and study staff that the health data that is shared as a part of the study will not identify you. Your name will be replaced with a study number, yourinitials, date of birth, and study visit dates. The study number will be a unique code assigned to you as you are added to the study. There may be a remote chance that information that identifies you may accidentally be shared. If that were to happen, both the study team and Sponsor would work together to remove the information that identifies you from their records. You will not be identified by name in any published reports about this study or in any other scientific publication or presentation. If you think that you were harmed from being in the study, the study team may also share health data about you with the hospital's insurer to resolve your claim. The following procedures will be used to protect the confidentiality of your data (and/or specimens). The researchers will keep all study records (including any codes to your data (and/or specimens)) locked in a secure location. A master key that links names and codes will be maintained in a separate and secure location. All electronic files (*e.g.*, database, spreadsheet, etc.) containing identifiable information will be password protected.  
Any computer hosting such files will also have password protection to prevent access by unauthorized users. Only the members of the research staff will have access to the passwords. Data (and/or specimens) that will be shared with others will be coded as described above to help protect your identity. At the conclusion of this study, the researchers may publish their findings. Information will be presented in summary format and you will not be identified in any publications or presentations. Any master key, audio recording, and other data described in this paragraph will be maintained in accordance with the security provisions of this paragraph until destroyed by the researchers. The study team, which may include affiliates of the team, may use the health data sent to them:
to see if the study drug works and is safe; to compare the study drug to other drugs; to develop new tests  
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for other activities (such as development and regulatory) related to the study drug.  
For these uses, the study team may share this health data with others involved in these activities, as long as they agree to only use the health data as described here. The study team and those working for or with the team, which may include affiliates of the team, may transfer health data about you from your country to other countries where the privacy laws are not as strict. Once the research team shares health data about you with others, it may no longer be protected by privacy laws. There is a risk that if people other than the study staff, or those working for or with the Sponsor, may get your health data and genetic information they could misuse it for purposes other than those outlined in this consent. The study team has strict privacy and confidentiality protection procedures in place to prevent this from occurring so the chance of this happening to you is extremely small. You may take away your permission to use and share health data about you at any time by writing to the study doctor. If you do this, you will not be able to stay in this study. Health data about you that has already been gathered may still be used and given to others as described in this document. To ensure the scientific integrity of the study, you may not be able to review some of your records related to the study until after the study has been completed. When the study is over, you may write to the study doctor to ask to see health data about you that was collected during the study and to correct any errors. Results obtained from planned genetic research will not be provided back to you or the study doctor. You should also know that the Tulane University Human Research Protection Office and the Biomedical Institutional Review Board (IRB) may inspect study records as part of its auditing program, but these reviews will only focus on the researchers and not on your responses or involvement. The IRB is a group of people who review research studies to protect the rights and welfare of research participants. To the extent allowed by law, every effort will be made to keep your personal information confidential. However, information from this study will be submitted to the study team and to the U.S. Food and Drug Administration. It may be submitted to governmental agencies in other countries where the study drug may be considered for approval. Medical records, which identify you and the consent form signed by you, will be looked at by the study team or the study team's representatives and may be looked at by the FDA and other regulatory agencies. A federal law called the Genetic Information Nondiscrimination Act ("GINA") generally makes it illegal for health insurance companies, group health plans and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:
Health insurance companies and group health plans may not request your genetic information that we get from this research.  
Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.  
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Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.  
Be aware that this federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
Clinical trial: NCT03770455
Section: Duration of Study Involvement
Subsections: Screening Phase:|Treatment Phase:|During The Study|How Long Will I Be In The Study?

Before you begin the study: If you agree to be in this study, you will be asked to sign and date this consent form. You will need to have the following exams, tests or procedures to find out if you can be in the study. This visit will last about 2 hours. These may be a part of regular care for someone who has mCRPC. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.  
You will be asked questions about yourself and your health problems, including past surgeries and past treatments for your prostate cancer.
You will be asked about medications that you are currently taking, including over-the-counter medications, herbal remedies, vitamins, and supplements.  
You will have a physical examination, which will include measuring your temperature, blood pressure, height, weight, heart rate, breathing rate, and health status.  
You will be asked about any disease-related symptoms you are experiencing. You will have an electrocardiogram (ECG) performed to measure the electrical activity of your heart.  
You will have a computed tomography (CT) scan or a magnetic resonance imaging (MRI) of your chest, abdomen, and pelvis, and if needed, other areas to evaluate your disease. A CT scan uses special x-ray equipment to take pictures of the body. The MRI scan uses magnetic and radio waves, meaning that there is no exposure to ionizing radiation. For the CT and MRI scan, you will be asked to lie down and keep still in the scanner for approximately 20 minutes. An x-ray of your chest may also be performed if necessary. You will only get an MRI if you are unable to undergo a CT scan due to allergy or other reason.
You will have a bone scan to identify changes involving the bone such as tumor or fracture. A bone scan uses bone-seeking radioactive material that is injected into a vein so it travels through the bloodstream. The radiation is detected by a camera that scans your body and takes pictures of how much the radioactive material collects in the bones.  
A sample of your blood (about 3 to 4 tablespoons) will be collected. This blood will be collected for routine safety blood tests, Prostate Specific Antigen (PSA), testosterone levels, thyroid function levels,
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and for other specialized research laboratory tests. These specialized research laboratory tests are used for biomarker and DNA analysis.  
A sample of your urine will be collected or routine safety tests  
If available, tumor tissue will be collected from either your previous biopsy or surgical specimen, or from a newly obtained biopsy for DNA research. If not available, you are still able to participate in the study.
If you are eligible to take part in the study, you will be asked to return to the clinic to receive your study drug. If you are not eligible, the study staff will discuss other treatment options with you.

The study can be divided into periods of time called "cycles". A cycle in this study will last 14 days. At the start of each cycle, you will be asked to visit the clinic to receive study drug and have regular pre-scheduled checkups and lab assessments.  
How long will I be on the study drug? Study participation will vary from person to person. Generally you will stay on the study drug until any of the following occurs:
Your disease gets worse You experience a serious side effect You develop another illness that prevents you from receiving treatment You do not follow the instructions of the study doctor  
You receive 52 study drug infusions (2 years)
The study doctor thinks that study treatment is no longer in your best interest

Take the investigational study drug:  
o Avelumab will be administered by an infusion into one of your veins. The infusion lasts about 30 minutes. Avelumab will be given as a 10mg/kg dose on Day 1 of every 2 week treatment cycle. The time between doses of avelumab will be approximately every 14 days (2 weeks). The time between doses may increase if you experience bad side effects.
Take the other non-investigational study drug:  
o Continue to take the hormone therapy (Zytiga (abiraterone acetate), Xtandi (enzalutamide),
Erleada (apalutamide), or ODM-201 (darolutimide)) and androgen deprivation therapy (ADT), that you have been prescribed.

If you decide to participate, you will be on this study for the rest of your life, or until the study closes. You will be asked to remain active on study drug for two years or until your cancer worsens (according to the CT/MRI, or bone scan results), you are unable to tolerate the study drug, your doctors determines that you should begin another cancer treatment, or you decide to withdraw consent. After your follow-up safety visit, you will visit the clinic about once every 3 months for up to 12 months after starting the study. If you discontinued study drug for reasons other than disease progression, clinic study staff will collect information related to the progression of your disease (for example standard of care scans, standard of care labs, new therapies) to follow you until your disease gets worse. After all of your study and follow up visits are completed, we will continue to contact you by phone every 6 months to find out the status of your health. You can choose to stop participating at any time without penalty or loss of any benefits to which you are entitled. However, if you decide to stop participating in the study, we encourage you to talk to your doctor first.
Clinical trial: NCT03770455
Section: Participant's Rights
Subsections: Can I Stop Being In The Study And What Are My Rights?

You do not have to be in this study if you do not want to. If you agree to be in the study, but later change your mind, you may drop out at any time. There are no penalties or consequences of any kind if you decide that you do not want to participate. If you withdraw from the study, no new data about you will be collected for study purposes unless the data concern an adverse event (a bad effect) related to the study. If such an adverse event occurs, we may need to review your entire medical record. All data that have already been collected for study purposes, and any new information about an adverse event related to the study, will be collected. Your doctor may decide to take you off this study if your condition gets worse, if you have serious side effects, if your study doctor determines that it is no longer in your best interest to continue, you do not follow the procedures of the study, or you start another prostate cancer therapy. The study team and regulatory agencies may stop this study at any time without your consent. If this occurs, you will be notified, and, your study doctor will discuss other options for treatment.  
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You may withdraw your consent at any time. The information collected prior to your withdrawal of consent will still be part of the study data. However, no new information will be collected.  
We will tell you about new information that may affect your health, welfare, or willingness to stay in this study.
Clinical trial: NCT03770455
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks, Discomforts Or Inconveniences Of The Study?|Rash  Non-Cardiac Chest Pain|Other Side Effects Linked To Medical Procedures During The Clinical Study Blood Samples|Electrocardiogram (Ecg)|Ionizing Radiation Exposure|What Happens If I Am Injured Or Sick Because I Took Part In The Study? If You Need Immediate Assistance, Go To Your Nearest Emergency Room For Treatment Or Dial 911 And Inform Emergency Personnel That You Are In This Study.

In a clinical study like this one, every risk or side effect cannot be predicted. Each person's reaction to an investigational drug, device or procedure may be different. You may have a side effect or be at risk for symptoms, illnesses and or complications that could not be predicted by your study doctor or the study team of this clinical study. It is possible that the symptoms of your condition will not improve during the study or may even worsen. For your safety, you must inform your study doctor about all medicines, vitamins, and herbal supplements you are taking. In addition, you must inform them about any adverse effects.  
  
PDL-1 inhibition with Avelumab and concurrent second-generation ADT in African Americans with castrateresistant metastatic prostate cancer.  
Three types of risks are associated with avelumab: general signs and symptoms, reactions that occur during or following the infusion (so called infusion-related reactions), and immune side effects. The following general side effects have been observed in ≥ 10 % of patients among 1738 patients treated with avelumab according to the results from two oncology clinical studies in patients with various solid tumors:  
| Observed in 10% or more of patients   |                                                                    |    |                               |
|---------------------------------------|--------------------------------------------------------------------|----|-------------------------------|
|                                      | Fatigue (tiredness)                                                |    |                               |
|                                      | Nausea (feeling sick to the stomach)                               |    |                               |
|                                      | Diarrhea Frequent loose, watery stools                             |    |                               |
|                                      | Constipation (difficulty passing stools)                           |    |                               |
|                                      | Decreased appetite                                                 |    |                               |
|                                      | Infusion related reaction                                          |    |                               |
|                                      | Weight decreased                                                   |   | Dyspnea (shortness of breath) |
|                                      | Pruritus (itching)                                                 |    |                               |
|                                      | Edema peripheral (build-up of fluid in the  body causing swelling) |    |                               |
|                                      | Musculoskeletal pain (including back pain,  neck pain)             |    |                               |
|                                      | Arthralgia (joint pain)                                            |    |                               |  
Fatigue (tiredness) Nausea (feeling sick to the stomach)   
Dyspnea (shortness of breath) Pruritus (itching)
The following side effects (regardless of relationship to study drug) have been observed in less than 5% of the patients treated with the study drug:

Allergic reactions or reactions in the context with the infusions might occur during or after the infusion. Although avelumab is a fully human protein the risk cannot be completely excluded. Symptoms may include chills or shaking, fever, flushing, back pain, belly pain, shortness of breath or wheezing, decrease in blood pressure, and hives. Infusion-related reactions have already been observed under treatment with avelumab. In general, these reactions are mild to moderate and generally resolve with a slowdown or discontinuation of the infusion and with appropriate drugs, but in very rare cases severe to life-threatening (less than 1%) and even fatal reactions (not observed with avelumab) might occur, which require advanced cardiac life support. For the prevention of infusion-related adverse effects and possible allergic reactions you will receive a premedication of an antihistamine drug (so-called H1 blocker) and acetaminophen 30 to 60 minutes before every infusion.  
In addition, side effects resulting from an increased activity of the immune system have also been observed. The side effects listed below may be temporary, long term, permanent or result in death. However, most of these side effects are reversible. That means they will stop once the drug is discontinued. The reactions that are more severe require treatment with drugs that decrease the immune system function, also called  
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PDL-1 inhibition with Avelumab and concurrent second-generation ADT in African Americans with castrateresistant metastatic prostate cancer.  
immunosuppressant drugs (like corticosteroids or more potent drugs). No immune side effects were observed in 10% or more of patients.  
The following immune-mediated side effects have been observed in patients receiving the study drug and might occur, such as: Immune side effects observed in 5% to less than 10% of patients
**Abnormal function of the thyroid gland (could include low or high function or inflammation of the**
thyroid gland): may include rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; hair loss; changes in mood or behavior such as irritability or forgetfulness; feeling cold; constipation; voice gets deeper.  
**Inflammation of the skin (rash):** may include skin rash, itchy skin, skin redness, skin blisters, or peeling.  
Immune side effects observed in 1% to less than 5% of patients
**Inflammation of the large intestine (colitis):** may include diarrhea (loose stools) or more frequent bowel movements than usual; blood in stools or dark, tarry, sticky stools; severe stomach area (abdomen) pain or tenderness.  
**Inflammation of the lungs (pneumonitis):** may include new or worsening cough, shortness of breath, chest pain.  
Immune side observed in less than 1% of patients:
**Inflammation of the liver (hepatitis):** may include yellowing of skin or of the whites of eyes; severe nausea or vomiting; pain on the right side of stomach area (abdomen); drowsiness; dark urine (tea colored); bleeding or bruising more easily than normal; feeling less hungry than usual.  
**Inflammation of the kidneys (nephritis):** may include urinating less than usual; blood in urine; swelling in ankles; loss of appetite.  
**Low function of the adrenal glands (glands on top of the kidneys)**, which may be due to the reduced function of the pituitary gland (a gland in the head): may include very low blood pressure; extreme tiredness.  
**Increase in blood sugar (diabetes):** may include urinating more often than usual; feeling more hungry or thirsty than usual, nausea or vomiting, stomach area (abdomen) pain.  
**Inflammation of the eyes (uveitis):** may include changes in eyesight.  
**Inflammation of the muscles (myositis):** may include severe or persistent muscle or joint pain; severe muscle weakness.  
**Inflammation of the heart (myocarditis):** may include chest pain or tightness; tiredness; changes in heartbeat, such as beating fast, or seeming to skip a beat, or pounding sensation; swelling of feet and legs; trouble breathing.  
**Inflammation of the nerves (Guillain-Barre syndrome):** may include "pins and needles" sensations in arms and legs; weakness in legs that spreads to the upper body and may lead to temporary paralysis.  
Single cases of immune-mediated pneumonitis, immune mediated hepatitis and immune-mediated myocarditis with fatal outcome have been observed with avelumab.  
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If any of these side effects occur, you must inform your study doctor immediately.

You will need to have samples of blood taken during the clinical study for laboratory testing. You may experience temporary discomfort from this. The needle sticks may cause local pain, bruising, swelling, lightheadedness, dizziness and rarely, fainting and/or a possible infection from the needle stick.

This test is not invasive and uses small sticky pads that are placed on your chest, arms and legs to measure the electrical activity of your heart. There may be mild discomfort from the sticky pads and a possibility of the skin being irritated by the adhesive on the sticky pads. Some hair may need to be shaved prior to the placement of the sticky pads.  
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PDL-1 inhibition with Avelumab and concurrent second-generation ADT in African Americans with castrateresistant metastatic prostate cancer.

CT and bone scans in the clinical study will mean you are exposed to more radiation than normal, which could lead in the worst case to any radiation associated diseases in the future. The contrast substance injected during the CT scan may cause pain, burning feeling, sweating and rarely a serious allergic reaction that can be serious - if you know you're allergic to iodine; you must inform your doctor immediately. The contrast agent used in the CT scan may cause kidney damage, especially if you are diabetic, dehydrated and if you are older. In addition, the thyroid function may be affected. Please inform your doctor if you meet these particular risk factors. If a CT scan is not recommended by your study doctor, instead a MRI may be performed which does not use radiation. For your MRIs, you will receive a contrast agent called gadolinium administered intravenously prior to each MRI. It will allow for a better image to be seen during the MRI. This contrast agent may occasionally cause nausea and vomiting. Very rarely, it may cause slight warmth or pain at the injection site. Allergic reactions may also occur very rarely, and, in extremely rare instances, these can be potentially serious. If you suffer from a renal disease, the contrast dye that is injected while the MRI scan is taken may be poorly tolerated and therefore, it is important to advise your doctor if you are suffering from a renal (kidney) disease. Also if you have had any type of device placed inside your body for medical reasons (e.g. pacemaker, cerebral aneurysm clips or a heart valve replaced), you should inform your doctor as you may not be able to have an MRI.

In the event you become sick or injured during the course of the research study, immediately notify the principal investigator or a member of the research team. The Tulane University Health Sciences Center and the investigators in this protocol will provide necessary medical treatment for any injury or illness which may arise from your participation in this research We reserve the right to bill you, your insurance company or other third parties, if appropriate, for the medical care you receive to treat an injury or illness that arises from or during you participation in the study. You will be responsible for payment of any deductibles, coinsurances and co-payments required by your insurer, and if your insurer or other third party refuses to pay for the medical care you get for the injury or illness, you will be responsible for paying costs associated with treatment. The Tulane University Health Sciences Center and the sponsor do not offer any form of compensation (such as payment for lost wages or for emotional suffering) if you suffer injury or illness arising from participation in this research. You are not giving up any of your legal rights by signing this form. If you have any questions about your rights as a research subject, please call the Tulane University Human Research Protection Office at (504) 988-2665 or email irbmain@tulane.edu.
Clinical trial: NCT03770455
Section: Procedures
Subsections: What Are The Study Procedures? What Will I Be Asked To Do? Subject Responsibilities: If You Are Eligible And Decide To Take Part In The Study, You Will Need To Do The|Study Visits Will Last 1-1.5 Hours. The Following Assessments Will Occur At All Study Visits:

following things:
Report to the study clinic for all scheduled visits and other visits as requested by the study staff Report any reactions or unwanted side effects (adverse events) to your study doctor Report taking any additional medications to your study doctor. This includes vitamins, dietary supplements, herbal or alternative remedies, medications that are prescribed by a doctor, and overthe-counter medications. If you feel that you need to take a new medication or herbal remedy, you must call the study doctor and get approval before taking the medication.  
Blood and laboratory tests Radiology assessments via CT scan and bone scan  
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PDL-1 inhibition with Avelumab and concurrent second-generation ADT in African Americans with castrateresistant metastatic prostate cancer.  
The study staff will record the above information in your study records and follow any adverse event (side effect) that may occur. It is important that you immediately report any new symptoms or worsening of symptoms that you have to the study staff. You will continue to take the hormone therapy (Zytiga (abiraterone acetate), Xtandi (enzalutamide), Erleada (apalutamide), or ODM-201 (darolutimide)) and androgen deprivation therapy (ADT), that you have been prescribed. Receiving any other prostate cancer therapy or other investigational drugs is not allowed while you are participating in the study. The study staff will discuss these restrictions with you in more detail. Participation in this research study is completely voluntary. If you choose not to sign this consent form you will continue to receive care, but not as part of this study.

You will be asked about the medications you are currently taking, including all prescribed medications, over-the-counter medications, herbal remedies, vitamins, and supplements.  
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You will be asked about any new or continuing side effects or illnesses you have had since your last visit.  
You will have a physical examination, which will include having your weight, temperature, blood pressure, heart rate, and breathing rate measured.  
A sample of your blood (about 3 to 4 tablespoons) will be collected. This blood will be collected for routine safety blood tests, and tumor markers such as Prostate Specific Antigen (PSA).
On Study Day 1 of Cycle 2 and every 4 cycles or 8 weeks, treatment discontinuation, and the safety follow-up visit these additional assessments will occur.  
A sample of your blood (about 2 tablespoons) will be collected for thyroid function testing A sample of your urine will be collected or routine safety tests A sample of your blood (about 2 tablespoons) will be collected to measure your testosterone levels
Clinical trial: NCT03770455
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this study is to evaluate the response to Avelumab in African American men with metastatic castrate resistant prostate cancer (mCRPC). Avelumab is an investigational drug, which belongs to a family of molecules called anti-PD-L1 antibodies. PD-L1 is a cell surface protein, found in different human tumor types, which is considered to be able to inhibit an anti-tumor response of the immune system. Avelumab interferes with the activity of PD-L1 and is thought to potentially have an effect on the immune system (in particular white blood cells) in order to induce an anti-tumor attack. It is possible that African American men are more responsive to the inhibition of the PD-1 signaling pathway. We are trying to find out what effects, good and/or bad, Avelumab has on you, and whether Avelumab is effective in treating mCRPC. Avelumab is an investigational drug, in this disease. An investigational drug is one that is not approved for sale. Avelumab has been used in different diseases, such as Merkel cell carcinoma and urothelial carcinoma (bladder cancer).
Clinical trial: NCT03770455
Section: Voluntary Participation
Subsections: Documentation Of Consent:

I have read and understand this form and have decided that I will participate in the research project described above. I have been given enough time and opportunities to ask about the details of the research study and to decide whether or not to participate. Its general purposes, the particulars of involvement and possible risks and inconveniences have been explained to my satisfaction. I understand that I can withdraw at any time without giving any reason without my medical care or legal rights being affected. My signature also indicates that I have received a copy of this consent form.  
_____________________________________   
__________________________ Signature
___________________   
_____________________________________ Legally Authorized Representative Name  _______________________________ Representative's Authority to Act (Relationship   
__________________________  
  
  
   
  
_____________________________________  
  
 Printed Name of Person Conducting Review of Consent  
_____________________  
  
  
  
Signature _____________  
  
________________________________________________________________
Investigator Conducting Consent Signature _____________  
  
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PDL-1 inhibition with Avelumab and concurrent second-generation ADT in African Americans with castrateresistant metastatic prostate cancer.  
I am unable to read but this consent document has been read and explained to me by
___________________ (name of reader). I volunteer to participate in this research.  
____________________________________________ _____________
Clinical trial: NCT03770455
Section: Withdrawal from Study
Subsections: What If My Disease Worsens?|When You Are Finished Taking Study Drug:

If the assessment of your cancer by CT/MRI, or bone scan shows that your cancer may have worsened, you may be asked to have another radiographic assessment performed a minimum of 4 weeks later to confirm the worsening. The study doctor will discuss your options during the period between scans, which may include the following:
Continue to receive treatment with the study drug or; Hold the study drug until the time that the worsening is confirmed or; Discontinue from the study drug End treatment in the study, and start alternative treatments such as approved chemotherapy drugs, alternative hormonal therapy, other investigational therapies etc. Your study doctor will discuss what drugs are approved and available for treatment in your region.  
Terminate all treatment and move on to palliative or comfort care
If you elect to wait until the confirmation scan, you will not be eligible to receive any other medications except your study medication until the worsening of your disease is confirmed and study treatment is stopped. If the follow up radiographic assessment (after the assessment that first showed worsening of your cancer) shows that the size of your tumor has not increased further and your doctor thinks you are doing well you may be eligible to continue on the study drug.

End of Study Visit: An End of Study visit will be scheduled at the time of discontinuation. At this visit, the following procedures, in addition to the assessments done at all visits, will be performed:  
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A sample of your blood (about 3 to 4 tablespoons) will be collected. This blood will be tested for routine safety blood tests, PSA level, thyroid function testing, circulating tumor cell count and testosterone.  
A sample of your urine will be collected or routine safety tests Imaging assessments (CT/MRI and bone scans). If a previous scan was done within 4 weeks prior to your end of study date, another scan isn't needed.
Safety Follow-up Visit: When you stop taking study drug, you will be asked to come in for a safety follow-up visit about 30 days after your last study drug treatment or before you start new treatment for your cancer, whichever comes first. You will then enter the post-treatment follow-up period. The study doctor or staff will discuss with you when and on which days to report to the clinic for the follow-up visits. At this visit, the following procedures, in addition to the assessments done at all visits, will be performed:  
A sample of your blood (about 3 to 4 tablespoons) will be collected. This blood will be tested for routine safety blood tests, thyroid function testing, circulating tumor cell count and testosterone.  
A sample of your urine will be collected or routine safety tests
Routine follow up visits: Routine follow up visits will be scheduled every 12 weeks after your last dose of study drug to continue to monitor your health, for up to one year. Sometimes drugs like avelumab continue to work even after treatment stops. The study is designed to measure this potential effect. Consequently, it is important to continue to be followed in the study even after you stop treatment. At this visit, the following procedures will be performed:
You will be asked about your current anti-cancer therapy.  
You will be asked about any new or continuing side effects or illnesses you have had since your last visit.  
If you discontinued treatment and entered follow up without confirmed disease progression, your study team will ask you to for the following; until your cancer gets worse or you start a new treatment for your cancer:
o Collect a sample of your blood (about 3 to 4 tablespoons) will be collected. This blood will be collected for Prostate Specific Antigen (PSA).  
o Imaging assessments (CT/MRI and bone scans). If a previous scan was done or is scheduled within 4 weeks of the visit, another scan isn't needed.
If at any time during post-study drug treatment your cancer gets worse, or you start a new cancer treatment, you will move into the survival follow up phase. Survival follow up: We would like to contact you every 6 months to discuss your current anti-cancer therapy and verify your survival status. This visit can be conducted during a standard of care office visit or via telephone.  
Version 3.0 Date: 16Jan2019 Page **6 of 18** Subject Initials:______  
  
  
PDL-1 inhibition with Avelumab and concurrent second-generation ADT in African Americans with castrateresistant metastatic prostate cancer.  
Additional blood: If your blood collected at baseline for DNA research is not evaluable, an additional sample of your blood (about 1 teaspoon) may be collected in order to complete the DNA research. This sample can be collected anytime during the study. Your study doctor or nurse will explain if this applies to you.