NRG-GU008, also known as the “INNOVATE” study, is a clinical study for patients who have node-positive prostate cancer and need more treatment after prostatectomy. This trial compares the usual treatment of hormone therapy and radiation therapy, to apalutamide added to the usual treatment. The addition of apalutamide to the usual treatment could stabilize your cancer and prevent it from spreading. This study will help doctors learn if this different approach is better, the same, or worse than the usual approach.To decide if it is better, the study doctors will be looking to see if the study approach increases the time without prostate cancer spreading compared to the usual approach.The study drug, apalutamide, is already approved by the FDA for use in advanced prostate cancer; however, most of the time apalutamide is not used until hormone drugs stop working and after prostate cancer has spread.
More information about this particular study is located on ClinicalTrials.gov
If you over the age of 18 with prostate cancer that has spread to your lymph nodes, you may be able to participate. Your healthcare team is the best source for information about your treatment options, including cancer clinical trials. Be sure to take this information to your doctor to discuss your questions and concerns in general and specific to the INNOVATE study.
Are you interested in joining the study? Find a participating location
Additional information for the INNOVATE study can be found in the Patient Study Brochure. Download Brochure
Below, you can find FAQs about clinical research and this particular clinical trial.
Talk to your insurance provider and make sure that you understand what your insurance pays for and what it doesn’t pay for if you take part in this clinical trial. Also, find out if you need approval from your plan before you can take part in the study.
You will not be paid for taking part in this study.
Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.
Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.
At NRG Oncology, we focus on conducting clinical studies aimed to improve current cancer care practices and the lives of cancer patients. NRG Oncology partners with more than 1,300 member sites world-wide to research ways to improve treatment standards in the cancer community. Our organization is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI's National Clinical Trial's Network.