For more information regarding these studies, contact Cancer Research at (601) 984-1095.
RTOG 0924: Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
This study is being done to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles to hormone therapy and radiation therapy to the whole pelvic body area to find out which is better.
S1802: Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer
The purpose of this study is to compare the effects, good and/or bad, of adding either prostate removal surgery or radiation therapy to standard systemic therapy (SST), which is used to treat prostate cancer. Standard systemic therapy includes Androgen Deprivation Therapy (ADT) 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.
EA8153: Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial
The purpose of this research study is to compare any good or bad effects of using the chemotherapy drug cabazitaxel (also known as Jevtana®) with the usual approach of the hormone based therapy abiraterone acetate (also known as Zytiga®) in combination with prednisone on patients with advanced prostate cancer that have already undergone treatment with hormone therapy and the chemotherapy drug docetaxel. In this research study, you will get either the standard of care combination of abiraterone acetate and prednisone, or you will get abiraterone acetate and prednisone in combination with the chemotherapy drug cabazitaxel. To be better, the study drug should delay the development of resistance to abiraterone acetate and prednisone by 6 months or more compared to the usual approach.
NRG-GU002: Phase II-III Trial Of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or without Adjuvant Docetaxel
The purpose of this study is to compare any good and bad effects of using docetaxel along with the radiation therapy and hormone suppression therapy to using radiation and hormone suppression therapy alone 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 or 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.
S1500: A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)
This randomized phase II study to find out how well cabozantinib-s-malate, crizotinib, volitinib, or sunitinib malate work in treating patients with kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate, crizotinib, volitinib, and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
EA8143-A Phase 3 Randomized Study Comparing Perioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
The purpose of this study is to compare any good and bad effects of using nivolumab (also known as OPDIVO®), before and after the kidney cancer surgery to using the usual approach of surgically removing the kidney cancer followed by standard post-operative follow-up and monitoring. Nivolumab is a drug that may help stimulate the immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent cancer from returning but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for kidney cancer that has been removed, but is at risk for coming back. The study drug, nivolumab, is already FDA-approved for patients who have kidney cancer that has spread outside of the kidney to other organs or lymph nodes. The use of nivolumab in this study is investigational (not approved by the FDA) for your early stage of cancer where we do not know for sure if the disease has spread outside of the kidney. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approaches. To be better, the study drug should improve how long you are able to live without any signs or symptoms of cancer compared to the usual approaches.
A031501: Phase III randomized “Adjuvant study of MK-3475 (pembrolizumab) in muScle invaSive and locally ADvanced urOthelial caRcinoma” (AMBASSADOR) versus observation
The purpose of this study is to compare any good and bad effects of using a drug called MK-3475 (pembrolizumab) after the removal of your muscle invasive bladder cancer. MK-3475 is a drug that uses a person’s own immune system to treat cancer. This study will allow researchers to know whether treatment with MK-3475 is better, the same, or worse than the usual approach. To be better, the MK-3475 should increase life by 9 months or more, compared to observation alone. The use of MK-3475 could prevent your cancer from returning but it could also cause side effects. This immunotherapy drug, MK-3475, is already FDA-approved for use in other types of cancers, but for your type of cancer it is considered experimental.
IMMU-132-06: A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PI-1/PD-L1 Base Immunotherapy
The main purpose of this study is to determine whether treatment with sacituzumab govitecan improves tumor shrinkage and if so how long tumor shrinkage lasts in patients who have already received first line therapy. Information on overall safety, clinical benefit and other basic information and supporting data will also be collected in this study.
Sacituzumab govitecan is an investigational medication which means the FDA allows its use only in research.
Principal Investigator: John C. Henegan, MD