UC Davis Health Clinical Studies

Experimental Standard Systemic Therapy With or Without Surgery or Radiation For Metastatic Prostate Cancer

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This study is being done to test if we can lower the chance of your prostate cancer growing or spreading. We will test adding either prostate removal surgery or radiation therapy to standard treatment. We hope to find out if this will be better or worse than the usual approach for your prostate cancer. This study will compare the effects of adding either prostate removal surgery or radiation therapy to standard systemic therapy (SST). SST is used to treat prostate cancer. Standard systemic therapy includes Androgen Deprivation Therapy (ADT). It is given with or without the use of chemotherapy. ADT is an antihormone therapy whose main use is in treating prostate cancer. The combination of SST and surgery or radiation therapy is considered experimental.

Drug study, Phase 3
Male, age 18 years or older

Experimental Combination of Olaparib and Radium-223 For Metastatic Castration-Resistant Prostate Cancer That Has Spread

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This study is for patients with metastatic castration resistant prostate cancer. In this study, we hope to learn if we can lower the chance of your prostate cancer growing or spreading. We will test the addition of the experimental drug, olaparib, to usual treatment with radium-223. We are doing this study because we want to find out if this approach is better or worse than the usual approach. The usual approach is defined as care most people get for metastatic castration resistant prostate cancer. The usual approach for patients who are not in a study is treatment with chemotherapy or hormone therapy. Sometimes, combinations of these treatments are used. Additional available options include radiation therapy for some individuals. Your doctor can explain which treatment may be best for you. These treatments can reduce symptoms and may stop the tumor from growing for a few months or longer.

Other study, Phase [/1/,/ /2/]
Male, age 18 years or older

A Study of Experimental Accelerated vs Standard Chemotherapy for Germ Cell Tumors (formed from reproductive cells)

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Standard treatment for advanced germ cell tumors includes three chemotherapy drugs. This is called BEP (Bleomycin, Etoposide, and cisPlatin). BEP is given with a drug called pegfilgrastim or filgrastim. This makes white blood cells grow. These drugs are given over the course of 3 weeks. This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen. It will use the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental. This method works by giving the dose of chemotherapy drugs over a shorter length of time. Instead of the standard 3 week-cycle, patients would receive their treatment in a 2 week-cycle. The overall goal of this study is to determine whether accelerated BEP will be effective and well-tolerated for patients with advanced GCTs. We don’t yet know if accelerated treatment is helpful in advanced GCTs and we are hoping this study will answer that question.

Drug study, Phase 3
Any, age 11 to 45 years old

A Study of the Safety and Activity of Experimental ABBV-744 For Metastatic Prostate Cancer and Acute Myeloid Leukemia

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This is a research study for an experimental drug called ABBV-744. It will be studied in patients with relapsed/refractory acute myeloid leukemia (AML). An investigational drug is one that has not been approved by the FDA. The purpose of this study is: - to see if ABBV-744 is safe - to determine a safe dose of ABBV-744 - to see how much ABBV-744 is in your blood at various times (these tests are called "pharmacokinetics" or "PK") - to determine if treatment with ABBV-744 leads to tumor shrinkage. This study is for patients with relapsed (cancer has returned) or refractory (cancer is not responding to treatment) acute myeloid leukemia. The study sponsor (AbbVie) requests that we site collect tissue samples (including blood samples and tumor biopsies) for research purposes. This can help researchers (including your doctor and AbbVie) to better understand why certain people respond differently to ABBV-744. This is called “biomarker” research. ABBV-744 is a drug called a Bromodomain and extra-terminal (BET) inhibitor. BET proteins read DNA modifications that determine which genes are active. ABBV-744 interferes with this reading. If reading such DNA modifications are needed for the survival and growth of cells in a tumor, the tumor may be slowed or stopped.

Drug study, Phase 1
Any, age 18 years or older

A Study of the Effects of Chemotherapy on Fertility in Osteosarcoma (bone cancer) Survivors

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Incredible progress has been made in curing childhood cancers over the past 20 years. With all this success has come the awareness that childhood cancer treatment may lead to complications in some patients. This study is for patients who have previously received treatement for osteosarcoma (a type of bone cancer). Some chemotherapy drugs cause fertility problems (difficulty fathering children) in male patients. We do not know if cisplatin with or without ifosfamide causes similar problems. Problems may occur later in life for patients initially treated as adolescents and young adults. We are doing this study to learn more about possible long-term effects. The main goals of this study are: • To look at potential effects on fertility in male osteosarcoma survivors treated with cisplatin with or without ifosfamide. This will be compared to male controls without a history of cancer. • To learn whether cisplatin with or without ifosfamide changes the DNA in sperm. The other goal of this study is: • To explore how a person’s genetic makeup might change the effects that treatments for osteosarcoma have on male fertility.

Procedure study
Male, age 18 to 50 years old

A Study of Experimental Radiation Therapy With or Without Apalutamide For Stage III-IV Prostate Cancer

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This research study is for patients with prostate cancer who had surgery to remove the prostate. If your PSA level (a measure of prostate cancer) shows that your cancer has returned, this study may be right for you. People who are not in a study are usually treated with radiation therapy alone. Some patients may also receive hormone suppression drugs. However, these drugs are FDA approved for more advanced prostate cancer or prostate cancer that has spread. Therefore, hormone suppression drugs are usually not given. For patients who receive the usual approach (radiation therapy alone), about 62 of 100 patients are free of cancer after 5 years. This study will compare the effects of using the experimental drug apalutamide (study drug). It will be given along with usual radiation therapy. This combination treatment will be compared to using usual radiation therapy alone. The study drug is a hormone suppression drug. The study drug is experimental and is not FDA-approved to treat prostate cancer. The addition of the study drug to usual radiation could shrink your cancer/prevent it from returning, but could also cause side effects. This study will allow researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should reduce the chance of your cancer growing back compared to the usual approach.

Drug study, Phase 2
Male, age 18 years or older

A Study of Experimental Stereotactic Body Radiation Therapy (radiation treatment in a shorter amount of time) For Prostate Cancer

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This study will compare any good and bad effects of using stereotactic body radiation therapy (SBRT). SBRT gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment may prevent the tumor from returning but it could also cause side effects. This study will test whether using SBRT is better, the same, or worse than the usual approach.

Radiation study, Phase 3
Male, age 18 years or older

A Study of the Effects of Intermittent Fasting on Energy, Hormones, Body Composition, and Performance in Male Runners

The study team hopes to learn more about how time restricted eating affects performance and health in male runners.

This study is designed to test the effects of four weeks of time restricted feeding (16 hours fasting and 8 hours feeding). These effects will be compared to four weeks of a more traditional eating pattern (12 hours fasting and 12 hours feeding). The study team will look at the following in male competitive runners: • Resting energy expenditure • Blood markers of metabolism and hunger • Body composition • Cardiovascular health • Substrate utilization (carbohydrate and fat burning) • Fitness

Behavioral study
Male, age 20 to 40 years old
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