NRG-GU013 (HIGH FIVE): Testing shorter duration radiation therapy versus the usual radiation therapy in patients with high-risk prostate cancer


Currently Available for Patients

 

 

About This Study


NRG-GU013 is a clinical study for people with high-risk prostate cancer. Currently, patients with this type of cancer are treated with surgery, radiation, or hormone therapy drugs that are approved by the Food and Drug Administration (FDA). Sometimes a combination of these treatments is used. NRG-GU013 will be testing if radiation delivered in 5 treatments over 2 weeks using a higher dose per treatment can prevent your cancer from coming back at least as well as the usual radiation treatment delivered in 20 to 45 treatments over 4 to 9 weeks.  We are doing this study because we want to find out if this approach is the same as the usual approach for your prostate cancer.  

More information about this particular study is located on ClinicalTrials.gov 

Am I eligible for this study?

If you over the age of 18 with high-risk prostate cancer, 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-GU013 study. 

Are there other studies for which I might be eligible?

Please talk to your healthcare team to see if there are other clinical studies for which you may be a good fit. Click here if you would like to view a more detailed chart of other studies available.

Find a Study Location

Are you interested in joining the study?  Find a participating location

Want more information?

Additional information for the ‘High Five’ study can be found in the Patient Study Brochure on the NRG Oncology website. Download the Brochure

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Frequently Asked Questions

Below, you can find FAQs about clinical research and this particular clinical trial.

The NRG-GU013 Study FAQ

If you are over the age of 18 with high-risk prostate cancer, you may be able to participate.

This study will be testing if radiation treatment delivered in 5 treatments over 2 weeks using a higher dose per treatment can prevent your cancer from coming back at least as well as the usual radiation treatment delivered in 20 to 45 treatments over 4 to 9 weeks. 

If you decide to take part in this study, you will either get usual radiation therapy which is 5 treatments a week for a total of 20 to 45 treatments given over 4 to 9 weeks, or you will get the shorter radiation therapy which is a total of 5 treatments of a higher dose of radiation given over 2 weeks using a type of radiation treatment called stereotactic body radiation therapy (SBRT).  SBRT delivers a high dose of radiation more precisely to the tumor to spare normal tissue.

The usual approach for patients who are not in a study is treatment with surgery, radiation, or hormone therapy drugs approved by the Food and Drug Administration (FDA). Sometimes, combinations of these treatments are used.  Your doctor can explain which treatment may be best for you.  

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 approach 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 approach 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 approach may be made. 

If you are placed in the group that receives shorter duration radiation, your treatment will take less time to complete. There is evidence that this radiation therapy is effective in stabilizing your type of cancer. It is not possible to know now if the study approach will result in the same amount of time without your cancer spreading compared to the usual approach.  This study will help the study doctors learn things that will help people in the future.

After you finish your radiation treatment, your doctor will continue to follow your condition for  your lifetime and watch you for side effects. They will check you every 6 months for a total of 5 years and then switch to yearly checks for your lifetime.  
No. Taking part in this study is voluntary. You are free to choose to participate or not to participate. If you choose to participate in this study, you are able to leave the study at any time. If you decide not to take part in this study, your doctor will discuss other treatment options with you.
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 the radiation therapy.
• 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 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 and any company 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 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). 

Clinical Studies FAQ

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“.

    If you decide not to take part in a clinical study, you still have other choices. Talk to your doctor about your other choices.For example:
    • 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

    About NRG Oncology

    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.