All studies
Active not recruitingPHASE2INTERVENTIONAL

Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer

This research is looking into a new way to give radiotherapy for prostate cancer. Currently, patients often have 25 radiotherapy sessions to their pelvis. This study is testing if a newer, shorter treatment, involving only 5 sessions with higher doses of radiation each time, can give similar results. Doctors want to see if this shorter approach is just as effective and if it impacts people's quality of life in a similar or better way. If successful, this quicker treatment could be much more convenient for patients and might become the standard way to treat prostate cancer in the future. The study will also look at any side effects and how well the cancer is controlled.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Enrolment target
58
Start
07 Feb 2020
Estimated completion
01 Mar 2027

What is this study about?

This study is about finding the best way to treat prostate cancer with radiotherapy. Radiotherapy uses special X-rays to kill cancer cells. Currently, a common treatment involves receiving radiotherapy to the whole pelvis over 25 sessions. Each session uses a certain dose of radiation.

Researchers are investigating if a new approach, called 'hypofractionated' radiotherapy, could work just as well, or even better. This new approach involves giving a higher dose of radiation in each session, but over only 5 sessions instead of 25. The aim is to see if this much shorter treatment course is as effective at treating the cancer, is just as well-tolerated by patients, and doesn't negatively affect their quality of life.

If this shorter, 5-session treatment proves to be safe and effective, it would be much more convenient for patients, as it means fewer hospital visits. This study will also look at any side effects from the new treatment and how well it controls the cancer. The information from this study could help doctors decide if this newer, quicker treatment should become the standard way to treat certain prostate cancers in the future.

Key takeaways

  • This study compares a shorter radiotherapy treatment (5 sessions) with the standard treatment (25 sessions) for prostate cancer.
  • It aims to see if the shorter treatment is equally effective, safe, and improves quality of life.
  • If successful, the new treatment could offer greater convenience for patients.
  • The study measures cancer control, side effects, and patient well-being.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you need to be 18 years or older and have prostate cancer that has been confirmed by doctors. Your cancer should be considered 'unfavourable intermediate' or 'high-risk', which are terms used by doctors to describe how likely the cancer is to spread or grow. You also need to be generally fit and well enough to take part.

There are some reasons why you might not be able to join. For example, if you've already had radiotherapy in your pelvic area, or certain other treatments like cryosurgery or a procedure called a prostatectomy, this study might not be suitable for you. You also cannot have cancer that has already spread to other parts of your body, as confirmed by scans.

Other reasons you might not be able to join include having certain serious health conditions like inflammatory bowel disease or other connective tissue diseases, or if you are not well enough for general anaesthesia. You also need to be willing and able to fill out questionnaires during the study.

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 18 years old or older?
  2. Do you have confirmed prostate cancer that hasn't spread?
  3. Have you not had previous radiotherapy to your pelvis?
  4. Are you generally fit and well?
  5. Are you willing to complete questionnaires about your quality of life?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly put into one of two groups. One group would receive the standard radiotherapy treatment, which is 25 sessions of external radiotherapy to your pelvis. The other group would receive the new, shorter radiotherapy treatment, which is 5 sessions of external radiotherapy to your pelvis, each with a higher dose. Both groups might also receive another type of radiation treatment called High Dose Rate Brachytherapy (HDR-BT).

Throughout the study, you would have regular appointments for your treatments and follow-up checks. You would also be asked to complete questionnaires to help researchers understand the impact of the treatments on your day-to-day life. The doctors will monitor your health throughout the study.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving state-of-the-art care and being closely monitored by a specialist team. You might also help advance medical knowledge, potentially leading to better treatments for others in the future. However, there are also potential risks, including side effects from the radiotherapy treatments, which could be different depending on which treatment group you are in. It's important to remember that you can stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

  • Tom Baker Cancer Centre
    Verified postcode
    Calgary, Canada
  • BC Cancer
    Verified postcode
    Kelowna, Canada
  • London Regional Cancer Program of the Lawson Health Research Institute
    Verified postcode
    London, Canada

Common questions

What is 'hypofractionated' radiotherapy?

It's a way of giving radiotherapy where you have fewer, but higher-dose, treatment sessions. In this study, it's 5 sessions instead of the usual 25.

What is 'standard of care' radiotherapy?

This refers to the current, widely accepted best treatment for a particular condition, which in this case is 25 sessions of radiotherapy.

Will I definitely get the new 5-session treatment?

No, participants are randomly assigned to either the 5-session treatment or the standard 25-session treatment, like flipping a coin for fairness.

Why are doctors doing this study?

They want to find out if the shorter, 5-session treatment is just as good, safe, and convenient as the current 25-session treatment. This could make future treatments better for patients.

What does 'quality of life' mean in this study?

It refers to how the treatment affects your daily well-being, including any side effects, how you feel, and your ability to do normal activities.

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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