Current and Upcoming Prostate Cancer Clinical Trials at Duke
A clinical trial is a research study with human volunteers. Today, these types of studies are central to translating medical research into proven patient care. Each study is designed to collect information that is used to answer specific questions. Answering the questions leads to better ways to prevent, diagnose, or treat cancer. The goal of many clinical trials is to show whether a specific study drug, combination of drugs or procedures are effective. Genomic profiles are very new and therefore we need to determine the best way to use them in a medical setting. Because these methods are still being developed they are considered investigational, and currently genomic profiles are only available to patients taking part in one of our clinical trials. The goal of our prostate cancer clinical trials is to collect more information about the genomics profiles of different types of prostate cancers. Read further about our open and upcoming clinical trials.
Neoadjuvant Trials for High-Risk Localized Prostate Cancer
Neoadjuvant therapy is treatment given before intervention surgery such as prostatectomy. Our current studies focus on clinical results and genomic profiles of men with high and intermediate risk, localized prostate cancer who receive neoadjuvant therapy.
One such clinical trial, CALGB 90203, opened at Duke in December 2006. It is a clinical trial that compares the outcomes in men who had a radical prostatectomy with or without neoadjuvant docetaxel and hormone-deprivation therapy. The trial is being conducted through the Cancer and Leukemia Group B (CALGB). It is a large phase III trial (the final stage in testing a new treatment approach in humans). The trial recruits patients at different hospitals around the country. The trial is open to men with high risk, localized prostate cancer who are having a radical prostatectomy. We expect to recruit patients through 2012. CALGB 90203 will compare neoadjuvant docetaxel and hormone-deprivation therapy to immediate surgery. Two important goals of the trial are to find out if genomic profiles contain information that may predict recurrence and to understand how tumors become treatment resistant.
Other neoadjuvant trials for men with prostate cancer at Duke include phase I and phase II trials of:
- Radiation therapy.
- Docetaxel with the targeted treatment drug bevacizumab.
- A drug called sunitinib.
- A drug called rapamycin.
Trials for Men with Hormone-Refractory Prostate Cancer
Our clinical trial to test the Duke Docetaxel Response Predictor opened to patients in December 2006. This trial uses genomic profiles to study ways we can determine which prostate cancers will respond to docetaxel while others resist docetaxel. The trial will provide important information to guide our work on new combination therapies. This trial is open to men with metastatic, hormone-refractory prostate cancer.
In addition, we have a trial to study the investigational drug RAD001 in men with metastatic hormone-refractory prostate cancer. An investigational drug is one that has not been approved by the Federal Drug Administration (FDA) for use in treatment. The trial aims to find if we can identify which prostate cancer patients are sensitive to RAD001 and to understand how tumors become RAD001 resistant.
We also have a biopsy program for men with metastatic, hormone-refractory disease. The aim of this program is to examine if characteristics of a patient’s tumor can be used to anticipate how a patient will respond to chemotherapy and cancer drugs.
Basic Prostate Cancer Research at the IGSP
Basic cancer research gives scientists and doctors the tools and data they need to develop new and effective cancer treatments. The more we understand how cancer starts and grows, the more effectively we can treat the disease. Prostate cancer research at the IGSP also includes:
- Studying how genes function and their relationship to cancer.
- Discovering new cancer drugs.
- Studying how environmental substances affect prostate cancer.