All studies
RecruitingPHASE3INTERVENTIONAL

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

This study looks at a new, shorter way to deliver radiation therapy for men with high-risk prostate cancer, called Stereotactic Body Radiation Therapy (SBRT). Instead of 20-45 treatments over 4-9 weeks, SBRT involves just 5 treatments over two weeks. Doctors use special equipment for SBRT to target the cancer very precisely. The main goal is to find out if this shorter, more intense treatment is just as good at stopping the cancer from returning as the standard, longer course of radiation. Researchers will also look at side effects, and how the treatments affect daily life, such as bladder and bowel function.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
NRG Oncology
Enrolment target
1,209
Start
14 Dec 2023
Estimated completion
31 Mar 2036

What is this study about?

This study is designed for men in the UK who have been diagnosed with high-risk prostate cancer. You might be considered high-risk if your cancer has certain features, such as affecting a larger area, having a high PSA blood test result, or having a specific type of cancer cells when looked at under a microscope. The purpose of this study is to compare two different ways of giving radiation therapy, which is a common treatment for prostate cancer.

The usual way of giving radiation therapy involves many treatments over several weeks – sometimes 20 to 45 sessions over 4 to 9 weeks. This study is testing a newer approach called Stereotactic Body Radiation Therapy (SBRT). SBRT is a type of radiation that delivers a higher dose of radiation in a much shorter time, typically just 5 treatments over two weeks. It uses very precise equipment to make sure the radiation targets the cancer while trying to protect healthy tissues nearby.

The main question this study hopes to answer is whether this shorter SBRT treatment works just as well as the usual, longer radiation course in preventing the prostate cancer from coming back. We also want to understand the side effects of both treatments, how they might affect your day-to-day life, such as your ability to control your bladder and bowels, your energy levels, and your overall quality of life. By taking part, you could help doctors understand the best way to treat high-risk prostate cancer in the future.

Key takeaways

  • Compares a short radiation course (SBRT) to the usual longer course for high-risk prostate cancer.
  • Aims to see if SBRT works just as well to prevent cancer from returning.
  • Will track side effects and how treatment affects daily life.
  • You'll be randomly assigned to one of the two treatment groups.
  • Participation involves treatment, regular check-ups, and questionnaires.

Who may be eligible?

To join this study, you need to be a man aged 18 or older with a specific type of prostate cancer called adenocarcinoma, and your cancer must be considered 'high-risk'. This means it has certain characteristics, such as if it's spread slightly outside the prostate but not to distant parts of the body, or if your PSA blood test was very high, or if the cancer cells look particularly aggressive under a microscope.

There are also some things that would mean you can't join. For example, if your cancer has already spread to distant parts of your body. Also, you can't have had previous radiation treatment to your prostate area or certain other prostate treatments like surgery to remove the prostate, or other focused treatments to destroy prostate tissue. Your prostate also needs to be a certain size to safely receive the new treatment.

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 a man aged 18 or older?
  2. Do you have high-risk prostate adenocarcinoma?
  3. Has your cancer not spread to distant parts of your body?
  4. Have you not had previous radiation or surgery for your prostate cancer?
  5. Is your prostate gland a certain size (less than 100cc)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance (like flipping a coin) to one of two treatment groups. One group will receive the new, shorter radiation treatment (SBRT), which is typically 5 treatments over two weeks. The other group will receive the standard radiation therapy, which is usually 20-45 treatments over 4-9 weeks. Both treatments are given in a hospital setting and involve lying still while radiation is delivered.

You'll have various tests and appointments throughout the study. These will include scans like bone scans, CT scans, and MRI scans to check the cancer. You'll also be asked to fill out questionnaires about your quality of life, how you're feeling, and any side effects you might experience, especially related to your bladder and bowel function. These assessments are important for us to compare the two treatments. The total duration of your participation will depend on how long we need to follow your health and the cancer's behaviour, which could be several years.

Potential risks and benefits

Participating in this study might offer you some benefits, such as receiving state-of-the-art care and close monitoring of your prostate cancer. If the shorter radiation treatment proves to be as effective, it could mean fewer hospital visits and less disruption to your daily life compared to standard treatment. However, there are potential risks, as both radiation treatments can have side effects, which might include temporary issues with your bladder or bowel, or tiredness. These will be carefully monitored. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (398)

  • University of Alabama at Birmingham Cancer Center
    Verified postcode
    Birmingham, United States· Recruiting
  • The Kirklin Clinic at Acton Road
    Verified postcode
    Birmingham, United States· Recruiting
  • Lewis and Faye Manderson Cancer Center
    Verified postcode
    Tuscaloosa, United States· Recruiting
  • University of Arkansas for Medical Sciences
    Verified postcode
    Little Rock, United States· Recruiting
  • Kaiser Permanente-Deer Valley Medical Center
    Verified postcode
    Antioch, United States· Recruiting
  • Tower Cancer Research Foundation
    Verified postcode
    Beverly Hills, United States· Recruiting
  • Kaiser Permanente Dublin
    Verified postcode
    Dublin, United States· Recruiting
  • Kaiser Permanente-Fremont
    Verified postcode
    Fremont, United States· Recruiting
  • Washington Hospital
    Verified postcode
    Fremont, United States· Recruiting
  • Fresno Cancer Center
    Verified postcode
    Fresno, United States· Recruiting
  • Kaiser Permanente Fresno Orchard Plaza
    Verified postcode
    Fresno, United States· Recruiting
  • Kaiser Permanente-Fresno
    Verified postcode
    Fresno, United States· Recruiting

Common questions

What is 'high-risk prostate cancer'?

High-risk prostate cancer means the cancer has certain features that make it more likely to grow or spread, such as a higher PSA level, a certain type of cancer cell, or if it's spread slightly outside the prostate.

What is the difference between SBRT and usual radiation therapy?

SBRT delivers a higher dose of radiation in fewer, stronger treatments (like 5 sessions over two weeks), while usual radiation therapy gives smaller doses over many more sessions (like 20-45 sessions over 4-9 weeks).

Will I get to choose which treatment I receive?

No, you will be randomly assigned to one of the two treatment groups. This is like a fair coin toss to ensure the results are unbiased.

What kind of side effects might I experience?

Both types of radiation can cause side effects, which might include tiredness, or temporary changes in bladder and bowel function. These will be monitored closely by your healthcare team.

How long will I be involved in the study?

Your involvement typically lasts several years, as researchers need to follow your health and the cancer's behaviour over time to understand the long-term effects of the treatments.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Testing Shorter Duration Radiation Therapy Versus the Usual …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.