NRG-GU011, also known as the “NRG PROMETHEAN” study, is a study for men who were treated with either surgery or radiation for prostate cancer, and whose cancer has returned and is visible on a PET scan. If there are 5 or fewer lesions, known as oligometastatic disease, men would be eligible for this study, which tests whether adding the FDA-approved drug relugolix to radiation treatment to the metastases reduces the development of new metastases.Relugolix lowers testosterone production but is an oral hormone therapy which, when stopped, allows testosterone to recover more quickly than injectible forms of hormone therapy.
In prostate cancer that has spread to only a few areas, the usual treatment either involves hormone therapy or radiation therapy to the sites of metastasis to delay hormone therapy. Radiation therapy directed at the sites of metastasis is a very focused high dose of radiation used to control the cancer (called stereotactic ablative body radiotherapy, or SABR). SABR has been shown in some studies to delay further recurrence and to delay the need for hormone therapy. For patients who undergo the high dose radiation alone, about 66 out of 100 start hormonal therapy within 5 years.In studies of prostate cancer at an earlier stage, combining radiation and hormone therapy has improved outcomes over either therapy alone, and this study tests whether that is true for oligometastatic prostate cancer.
Men who participate on this study will receive either a placebo, a pill containing no medication, or relugolix in addition to radiation therapy. Researchers want to determine if high doses of radiation given directly to the sites of the cancer metastasis coupled with relugolix can help improve cancer control and prevent the cancer from growing or spreading further. Men who participate in NRG-GU011 will also be surveyed about their quality of life and symptoms at different points before, during, and following treatment to assess their wellbeing. These surveys help researchers learn more about this type of cancer and how the study treatments affect people.
More information about this particular study is located on ClinicalTrials.gov
If you are over the age of 18 with advanced-stage prostate cancer that has returned and spread with a limited number of metastases (up to 5 lesions) following treatment and you are NOT currently receiving androgen deprivation therapy, 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 NRG PROMETHEAN study.
Are you interested in joining the study? Find a participating location
Additional information for the NRG PROMETHEAN 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 or your insurance provider will not have to pay for the study drug, relugolix, or placebo while you take part in this 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.