UC Davis Health Clinical Studies

Experimental Niraparib With Radiation Therapy and Androgen Deprivation Therapy for High Risk Prostate Cancer

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This study is being done to answer the following question: Can we lower the chance of prostate cancer growing or returning by adding a new experimental drug to the usual treatment? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer that has a high chance of coming back. The purpose of this part of the study is to determine the ideal dose of the study drug. You are being asked to take part in the initial dose-finding part of this study (phase I). The purpose of this part of the study is to test the safety of the study drug niraparib added to usual treatment for your type of prostate cancer. The study drug is not approved by the FDA for use in patients with prostate cancer. We will test the safety of adding the study drug by looking at the side effects experienced by patients in this part of the study. If adding the study drug to usual treatment is safe, a second portion of the study (phase II) will open to additional patients. Phase II will compare any good and bad effects of the study treatment to the usual therapy. Researchers will use some of the information obtained from the patients in the dose-finding portion to find this out.

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

Experimental Antiandrogen Therapy and Radiation Therapy for Prostate Cancer

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The purpose of this study is to test the experimental medicine docetaxel. It will be compared to radiation therapy and hormone suppression therapy. This study drug is being tested in men with a high chance of prostate cancer recurrence after surgically removing the prostate. Docetaxel is FDA-approved for prostate cancer that has spread and does not respond to hormone suppression. In this study, docetaxel is being used off-label. Off-label means that the FDA has not yet approved docetaxel for this type of prostate cancer that has not spread. The addition of docetaxel to the usual radiation and hormone suppression therapy could shrink your cancer. It could prevent it from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study approach should decrease the chance of your cancer progressing by 30% or more compared to the usual approach.

Drug study, Phase [/2/,/ /3/]
Male, age 18 years or older

Study on Experimental Olaparib Plus Abiraterone for Metastatic Castration-resistant Prostate Cancer

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This research study is for patients who have metastatic Castration-resistant Prostate Cancer (mCRPC). The reason for the study is to find a more effective treatment for this disease. The research team hopes to find out if an experimental medication called olaparib is safe and effective. It will be tested in patients who are also given abiraterone treatment. Olaparib (tradename Lynparza™) is approved by the FDA for other types of cancer. It is considered experimental in this study. Abiraterone is already an approved medication for the treatment of some patients with prostate cancer.

Drug study, Phase 3
Male, age 18 to 99 years old

A Study of Experimental Apalutamide for High‑Risk, Localized or Locally Advanced Prostate Cancer

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The drug being studied is called experimental Apalutamide. Apalutamide has been used in different forms of prostate cancer. Experimental Apalutamide is a type of drug that blocks the action of testosterone. By doing so it may slow down or stop the growth of prostate cancer cells. Apalutamide has been approved by the FDA to treat non-metastatic hormone resistant prostate cancer. It is considered experimental in this type of prostate cancer. Apalutamide is also being studied to treat other forms of prostate cancer.

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

A Study of the Long-Term Safety and Effectiveness of Embosphere® PROstate - Post Market Study

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You are being invited to join a research study. This study will collect information about symptom improvement and events related to the Prostatic Artery Embolization (PAE) treatment. This study is for patients who have lower urinary tract symptoms from benign prostatic hyperplasia (BPH). Patients have had treatment with PAE with Embosphere Microspheres. This study device (Embosphere Microspheres) is an FDA approved device that is used at other hospitals but is not currently used at UC Davis. The purpose of this study is to evaluate the long-term effectiveness of PAE with Embosphere Microspheres. As this product is not offered here at UC Davis the sponsor is providing the product for the study. This is considered a post market study as it is already FDA approved. You are invited to be in this study because you have lower urinary tract symptoms from benign prostatic hyperplasia (BPH). Your doctor has scheduled a PAE procedure for you.

Device study, Phase 4
Male, age 18 years or older

A Study of the Experimental Medicine Niraparib for Men With High Risk Prostate Cancer

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You are being asked to take part in this study because: - you have high-risk prostate cancer. - there are alterations in your DNA repair pathways. - you have chosen to have a prostatectomy (surgical removal of prostate) to treat your prostate cancer. This study will test the effects of the experimental medicine Niraparib on your prostate cancer. This study will test the impact of Niraparib therapy prior (neoadjuvant) to radical prostatectomy (RP). Niraparib is currently being studied for the treatment of ovarian, breast and prostate cancer. Niraparib is FDA approved to treat adult patients with epithelial, ovarian, fallopian tube, or primary peritoneal cancer. It has not yet been approved by the FDA for use in prostate cancer.

Drug Study
Male, age 18+

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
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