All studies
Active not recruitingPHASE3INTERVENTIONAL

Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

This study is for men with prostate cancer, particularly those at moderate to high risk of their cancer returning. It compares two different approaches using a combination of hormone therapy and radiation. Hormone therapy helps control prostate cancer by reducing male hormones. Radiation therapy uses high-energy beams to kill cancer cells. Researchers want to find out if treating a larger area with radiation (the whole pelvis) alongside hormone therapy is more effective than treating just the prostate and nearby seminal vesicles. They will also look at side effects, quality of life, and how well the treatments stop the cancer from coming back or spreading. The goal is to improve how prostate cancer is treated.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Radiation Therapy Oncology Group
Enrolment target
2,590
Start
01 Jul 2011
Estimated completion
01 Jul 2031

Results

Results from this study

Posted May 2026

Results have been published for this study.

Primary outcome
Percentage of Participants Alive (Overall Survival)
Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
Full results on the registry

What is this study about?

This study is a clinical trial, which means it's a research study that helps doctors learn more about diseases and how to treat them. In this particular study, doctors are focusing on men with prostate cancer. Prostate cancer often relies on male hormones to grow, so one treatment approach is called 'androgen deprivation therapy,' which aims to reduce or block these hormones. Another key treatment is 'radiation therapy,' which uses powerful energy beams to destroy cancer cells.

The main aim of this study is to compare two slightly different ways of giving these treatments. Both groups in the study will receive hormone therapy and radiation. However, one group will have radiation directed at a slightly larger area, including the whole pelvis, while the other group will have radiation targeted more specifically at the prostate and nearby seminal vesicles. Both groups will also receive a very strong dose of radiation directed just at the prostate. The researchers want to see if treating the larger area with radiation, along with hormone therapy, leads to better outcomes for patients, such as living longer, controlling the cancer more effectively, and having a good quality of life.

They're not only looking at how long people live, but also if the cancer stays away, if it spreads to other parts of the body, and how treatments affect daily life, like fatigue. They'll also carefully track any side effects to understand which treatment approach is safest and most effective. By comparing these methods, the study hopes to find the best possible way to treat men with prostate cancer and improve their chances of a long and healthy life.

Key takeaways

  • This study compares two ways to combine hormone therapy and radiation for prostate cancer.
  • It aims to see if treating a larger area with radiation is more effective.
  • Both treatment groups will receive hormone therapy and different types of radiation.
  • Researchers will monitor survival rates, cancer control, side effects, and quality of life.
  • Participation involves regular medical check-ups, scans, and questionnaires.
  • The study is for men with moderate to high-risk prostate cancer that has not spread.

Who may be eligible?

This study is for men who have been diagnosed with prostate cancer within the last six months. Your cancer needs to be considered at a moderate or high risk of coming back. Your doctor would determine this based on things like your Gleason score (a measure of how aggressive the cancer cells look), your PSA level (a blood test), and how advanced your cancer is.

To join, you also need to have had some routine checks, including a physical exam, and scans (like CT or MRI) to make sure the cancer hasn't spread to your lymph nodes. If your scans show anything unusual in your lymph nodes, they must be small (1.5 cm or less) for you to be eligible. It's also important that scans show no evidence of the cancer having spread to your bones.

Your PSA blood test must meet specific conditions; for example, it shouldn't have been taken too soon after a biopsy or while you were on certain hormonal treatments. You also need to be generally well enough to go about your daily life without too much difficulty, as determined by a standard health score called the Zubrod Performance Status. This study is for adult men aged 18 and older.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult male (18 or older)?
  2. Did you receive a prostate cancer diagnosis in the last 6 months?
  3. Has your doctor said your prostate cancer is moderate to high risk?
  4. Have your scans confirmed the cancer has not spread to your bones?
  5. Are your lymph nodes clear or, if affected, are the nodes very small (1.5 cm or less)?
  6. Are you generally well enough for daily activities?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two treatment groups, meaning a computer will decide whether you get whole-pelvic radiation or radiation focused on the prostate and seminal vesicles. Both groups will also receive hormone therapy and a high-dose radiation boost to the prostate. The exact number of visits and tests will vary depending on your treatment plan, but it will involve regular check-ups, blood tests, and scans throughout your treatment and for a period afterwards to monitor your progress.

You will undergo various types of radiation therapy, which can be given in different ways depending on your specific situation. This will involve multiple appointments over several weeks. You will also take hormone therapy, which might be given as injections or tablets. Researchers will collect information about your health, any side effects you experience, and your quality of life. This will involve filling out questionnaires about your well-being. The total duration of your active treatment will be several months, followed by long-term follow-up appointments to track your health and the cancer's status.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving close medical attention from a team of experts and potentially accessing new or different treatment approaches that might be more effective than standard care. However, there are also potential risks involved. Treatments can have side effects, which might include fatigue, problems with digestion or urination, or sexual changes, among others. The study aims to carefully track these. You will be told about all known risks before you agree to take part. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (478)

  • University of South Alabama Mitchell Cancer Institute
    Verified postcode
    Mobile, United States
  • Anchorage Associates in Radiation Medicine
    Verified postcode
    Anchorage, United States
  • Alaska Oncology and Hematology LLC
    Verified postcode
    Anchorage, United States
  • Anchorage Oncology Centre
    Verified postcode
    Anchorage, United States
  • Katmai Oncology Group
    Verified postcode
    Anchorage, United States
  • Providence Alaska Medical Center
    Verified postcode
    Anchorage, United States
  • Fairbanks Memorial Hospital
    Verified postcode
    Fairbanks, United States
  • Arizona Breast Cancer Specialists-Gilbert
    Verified postcode
    Gilbert, United States
  • Arizona Center for Cancer Care-Peoria
    Verified postcode
    Peoria, United States
  • Cancer Center at Saint Joseph's
    Verified postcode
    Phoenix, United States
  • Saint Joseph's Hospital and Medical Center
    Verified postcode
    Phoenix, United States
  • Arizona Breast Cancer Specialists-Phoenix
    Verified postcode
    Phoenix, United States

Common questions

What is androgen deprivation therapy?

It's a treatment that lowers the amount of male hormones in your body, as these hormones can make prostate cancer grow.

What is radiation therapy?

This treatment uses high-energy X-rays to kill cancer cells and shrink tumours in your prostate.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to one of two treatment groups, like flipping a coin, so it's fair.

What does 'phase III trial' mean?

It means this is a large study comparing a new approach against a standard or different approach to see which is better and safer.

What are the main things the researchers are looking for?

They want to see if one treatment helps patients live longer, keeps the cancer from coming back, and affects quality of life and side effects differently.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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