RecruitingNAINTERVENTIONAL

High-Dose-Rate Brachytherapy

This study is exploring a new prostate cancer treatment called high-dose-rate brachytherapy, which uses precise radiation guided by MRI scans. The goal is to see if this method can better target cancer while reducing harm to healthy tissues. It's for men whose prostate cancer has returned after previous radiotherapy or for those with more advanced cancer who are also having external radiotherapy. Researchers want to understand the best ways to perform this treatment and gather important information for future, larger studies. This innovative approach could lead to more personalised and effective ways to treat prostate cancer, helping to improve outcomes for patients.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

400

Start

01 May 2009

Estimated completion

01 May 2025

Patients With Prostate Cancer

What is this study about?

This research study is about finding better ways to treat prostate cancer. Specifically, it's testing a special type of radiation treatment called high-dose-rate (HDR) brachytherapy. Instead of shining radiation from outside the body, brachytherapy involves placing small radioactive sources directly into the prostate tumour for a short time. What's new about this study is that it uses detailed MRI scans to guide these sources very precisely. This means doctors can target the cancer more accurately, aiming to give higher doses to the tumour while protecting nearby healthy tissues as much as possible.

The study is looking at two different groups of men. One group includes men whose prostate cancer has come back in the prostate after they've already had radiotherapy. For these men, the brachytherapy will be used to target the recurring cancer. The other group is men with more advanced prostate cancer who are receiving external radiotherapy. For them, the brachytherapy will act as an extra boost of radiation directly to the prostate.

The main aim of this study is to see how well this MRI-guided brachytherapy works in practice and whether it's safe and effective. The researchers want to learn about the best ways to carry out this treatment. The information gathered from this study will be very important for planning bigger studies in the future, helping to make this advanced treatment available to more men if it proves successful.

Key takeaways

This study tests a new, highly targeted radiation treatment for prostate cancer.
It uses MRI scans to guide radiation directly to prostate tumours.
The study is for men with recurring or advanced prostate cancer.
It aims to improve treatment accuracy and reduce side effects.
Information from this study will help develop future prostate cancer treatments.

Who may be eligible?

To join this study, you would generally need to be a man over 18 years old. For men whose prostate cancer has come back after earlier radiotherapy (this is called Arm 1 of the study), you'd need to have specific signs that the cancer has recurred and your PSA doubling time needs to be slower than 6 months. You would also need to have been part of an earlier biopsy study mentioned.

For men with more advanced prostate cancer who are planning to have external radiotherapy (this is Arm 2 of the study), your cancer would need to be considered high-risk, meaning it's either larger, more aggressive, or your PSA is high. You would also need to be fit enough to take part, as assessed by your doctors.

There are also some reasons why you might not be able to join. These include if your cancer has spread beyond the prostate, if you have certain medical conditions that make MRI scans unsafe (like a pacemaker), or if you have severe bleeding problems. You also couldn't join if you’ve had previous prostate brachytherapy or recent prostate surgery, or if your prostate gland is very large. The study also cannot include men with certain bowel conditions like Ulcerative Colitis or Crohn's Disease. Your doctor will carefully check all these points with you.

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.

Are you a man over 18 years old?
Have you been diagnosed with prostate cancer that has returned after previous radiotherapy, or is it advanced?
Are you generally fit and able to have an MRI scan?
Do you not have any other medical conditions that would make this treatment risky?
Have you not had previous prostate brachytherapy or surgery within the last 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of the treatment will involve the MRI-guided high-dose-rate brachytherapy. This procedure involves placing fine needles into your prostate under the guidance of MRI scans to deliver the radiation. You'll also likely have follow-up visits with your doctor to check how you're doing and how the treatment has worked. The total duration of your participation will depend on which group you are in and how long the researchers need to monitor your progress, but studies like this often involve follow-up for several months or even years.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving an innovative and highly targeted treatment for your prostate cancer that aims to reduce damage to healthy tissues. However, as with any medical procedure, there are potential risks, including side effects from the brachytherapy and MRI, or discomfort during the procedure. Your doctor will discuss all known risks and potential benefits with you in detail. Remember, joining a study is always voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (1)

University Health Network, Princess Margaret Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'brachytherapy'?

Brachytherapy is a type of radiation treatment where small radioactive sources are placed directly into a tumour for a short time to treat the cancer.

How is this treatment different from standard radiation?

The main difference is using MRI scans to guide the radiation sources very precisely into the prostate tumour, aiming to be more accurate and protect healthy tissues.

Who is this study for?

This study is for men with prostate cancer that has returned after earlier radiation, or for men with more advanced prostate cancer who are also having external radiotherapy.

Will I need to have a general anaesthetic for the treatment?

The brachytherapy procedure will involve some kind of pain relief, which could be conscious sedation, local anaesthesia, or spinal/epidural anaesthesia, depending on what's best for you.

What happens after the treatment?

You'll have regular follow-up appointments with your doctor to monitor your health and see how well the treatment has worked. The information gathered will help future research.

How to find out more

Peter Chung, MB ChB

peter.chung@rmp.uhn.on.ca 416 946 4501 Official trial record

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