Genitourinary Protocols (bladder, kidney, prostate)
Please check with your physician for additional protocols and/or information.
1. A031201: A Phase III Trial of Enzalutamide vs. Enzalutamide, Abiraterone & Prednisone for Castration Resistant Metastatic Prostate Cancer
The purpose of this study is to compare the effects, good and/or bad, of abiraterone, prednisone, and enzalutamide with enzalutamide alone on you and your prostate cancer to find out which is better. Doctors are uncertain about what is the best way to treat castration resistant prostate cancer (CRPC). In this study, you will get either the combination of abiraterone, prednisone, and enzalutamide or enzalutamide alone. Abiraterone and enzalutamide are both hormonal agents approved by the Food and Drug Administration for patients with castration-resistant metastatic disease. Each drug works in a different way to block hormones. Abiraterone and enzalutamide are both highly active drugs in men with CRPC. Abiraterone has recently received FDA approval for patients who have not received chemotherapy, such as you. In previous studies, enzalutamide appeared to be at least as active as abiraterone in patients with CRPC who have received prior chemotherapy, and it may be at least as active in patients who have not received chemotherapy. The combination of abiraterone, prednisone, and enzalutamide is considered to be experimental. In addition, giving enzalutamide in patients who have not received chemotherapy is considered to be experimental.
2. S0931: EVEREST: Everolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
The purpose of this study is to see whether treatment with everolimus after surgery for kidney cancer will increase the time without cancer returning. The current standard treatment after surgery is careful monitoring with no immediate treatment. Studies suggest that one way kidney cancer may grow is through chemical signaling through a protein named “mTOR”. Everolimus is a drug that stops signaling through mTOR and may therefore stop the growth of kidney cancer. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for use after surgery. In this study, you will get either everolimus or placebo (a pill with no medication). You will not get both.
3. S1216: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental. TAK-700 is a pill that works by reducing the levels of testosterone and other male hormones that help your prostate cancer grow. TAK-700 acts on the adrenal glands and inside the prostate tumors and slows the amount of male hormones being produced. By lowering the amount of male hormones in your body, TAK-700 is expected to control the growth of your prostate cancer.
4. E2810: Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
The purpose of this study is to determine whether taking an oral drug known as pazopanib (Votrient®) will reduce the risk of the cancer recurring in the future.
Pazopanib is approved by the FDA for patients who have metastatic renal cell carcinoma. However, it has not been tested in patients who have had all visible areas of their cancer removed surgically, and is considered experimental in this situation. We don’t know if pazopanib will be helpful to patients in this scenario. There is currently no standard of care for patients in this situation but careful observation without treatment is considered reasonable.
5. CALGB 70807: The Men’s Eating & Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance
You are being asked to take part in a research study of men who are undergoing active surveillance for their prostate cancer. The purpose of the study is to find out more about how diet may prevent prostate cancer from getting worse.
For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133.