Can the drug relugolix combined with radiation improve outcomes for men with limited metastatic “oligometastatic” prostate cancer?

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

This study is being done to determine if we can lower the chance of your prostate cancer growing or spreading by adding the drug relugolix to the usual radiation therapy.

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.

If you decide to take part in the study, you get randomly assigned to one of two possible treatments.Trial participants who are assigned to Treatment Group 1 will receive a placebo with high dose stereotactic ablative body radiation (SABR) to the sites of their metastasis. Trial participants who are assigned to Treatment Group 2 will receive the study drug relugolix with SABR to the sites of their metastasis. However, you and your doctor will not know which group you will be in.

People who are not in a study are usually treated with hormonal therapy or radiation therapy to help treat their cancer. In prostate cancer that has spread to only a few areas, the usual treatment either involves short term 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). Sometimes a lower dose of radiation is used at the sites of metastasis for symptom relief only. For patients who undergo the high dose radiation alone, about 66 out of 100 start hormonal therapy within 5 years.

If you choose to take part in this study, there is a risk that:

• You may lose time at work or home and spend more time in the hospital or doctor’s office than usual.
• You may be asked sensitive or private questions which you normally do not discuss.
• The study drugs may not be as good as the usual approach for your cancer at shrinking or stabilizing your cancer and preventing your cancer from spreading.
• The drugs used on this trial may cause side effects. Your doctor will review all of the potential side effects with you. It is important to tell your doctor about any side effects during the study so that they may be treated and so that potential adjustments to the study drugs may be made.

There is evidence that adding the study drug, relugolix, is effective in stabilizing your type of cancer. It is not possible to know now if the study drug will extend your time without disease spreading compared to the usual approach. This study will help the study doctors learn things that will help people in the future.

Both groups will receive the drug or placebo for 6 months and the SABR treatment for 1-3 weeks.

After you finish your study treatment, your doctor will continue to follow your condition and watch you for side effects. They will check at 3 and 6 months after you finish treatment, then every 6 months for 4 years, and then yearly.

You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer. This includes:

• the costs of tests, exams, procedures, and drugs that you get during the study to monitor your safety and prevent and treat side effects. 
• the costs of getting the study drug, relugolix, or placebo ready and giving it to you. 
• the costs of the radiation therapy and giving it to you. 
• your insurance co-pays and deductibles.

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.

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information and/or information about your specimens from this study will be kept in a central database for research. Your name or contact information will not be put in the database.

There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:

• NRG Oncology, Myovant Sciences GmbH, Pfizer Oncology, or the companies supporting the study now or in the future. This would include any organization helping the company with the study. 
• The National Cancer Institute (NCI) Central Institutional Review Board, which is a group of people who review the research with the goal of protecting the people who take part in the study. 
• The Food and Drug Administration (FDA) and the groups it works with to review research. 
• The NCI and the groups it works with to review research, including the Cancer Trials Support Unit (CTSU). 
• The NCI’s National Clinical Trials Network and the groups it works with to conduct research including the Imaging and Radiation Oncology Core (IROC).

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”.

Yes. They are exactly the same thing.

The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.

A clinical study may take place in many locations, such as:

physician offices

hospitals

clinics

A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.

No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials".

• You may choose to have the usual treatment approach (known as “standard of care”)
• You may choose to take part or learn more about a different study, if one is available
• You may choose not to be treated for cancer