Not yet recruitingPHASE2INTERVENTIONAL

Focal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost to External Beam Radiotherapy in Localized Prostate Cancer: A Phase 2 Randomized Trial

This research is comparing two ways of giving radiation therapy for prostate cancer. Both methods involve a 'boost' of radiation called High Dose-Rate Brachytherapy (HDR-BT), given alongside regular external beam radiation. One method treats the whole prostate, which is the standard approach. The other, newer method, called 'focal' HDR-BT, aims to focus the radiation specifically on the main area of cancer in the prostate. The main goal is to see if this more targeted approach can reduce side effects, particularly problems with urination, while still effectively treating the cancer. It's for men with certain types of prostate cancer where a clear cancer spot can be seen on MRI scans.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Joelle Helou

Enrolment target

Start

01 Feb 2026

Estimated completion

01 Mar 2033

Prostate Cancer

What is this study about?

This study is designed for men who have been diagnosed with prostate cancer that is considered intermediate or high-risk. This means the cancer needs treatment, but it hasn't spread beyond the prostate. The study is particularly for men whose MRI scans show a clear, main area of cancer within the prostate.

The research is comparing two different ways of giving an extra burst of radiation, called a 'boost', to the prostate. Both methods use 'High Dose-Rate Brachytherapy' (HDR-BT), which involves temporarily placing small radioactive sources inside the prostate. This boost is given in addition to standard external radiation therapy, where radiation comes from a machine outside the body. One group will receive the standard treatment, where the HDR-BT boost is given to the entire prostate. The other group will receive an experimental treatment, where the HDR-BT boost is focused only on the main cancerous area identified on the MRI scan.

The main aim of this study is to find out if targeting the radiation boost more precisely to the cancer (the 'focal' approach) can reduce side effects, especially those affecting how often and easily you pass urine. Doctors want to see if this new, more focused treatment can protect healthy parts of the prostate and surrounding areas better than treating the whole prostate, while still being effective against the cancer.

Key takeaways

Compares two radiation boost methods for prostate cancer.
One method targets only the cancer spot, the other treats the whole prostate.
Aims to reduce urinary side effects with the targeted approach.
For men with intermediate or high-risk prostate cancer visible on MRI.
Participation includes radiation treatments and regular follow-up questionnaires.

Who may be eligible?

This study is looking for men with prostate cancer that has been confirmed by a biopsy. It's for those with 'intermediate' or 'high-risk' cancer, meaning it's more serious but hasn't spread outside the prostate. Importantly, a doctor must be able to clearly see the main area of cancer on your MRI scan.

There are a few other criteria. Your general health should be good enough for treatment, usually meaning you can do light activities without much trouble. Your prostate shouldn't be too large, usually under 60 cubic centimetres, though there's some flexibility if your bladder symptoms are mild. You also can't have had previous radiation treatment to your pelvis, or recent prostate surgery or other intensive treatments like HIFU in the last six months.

Things that would prevent you from joining include having cancer that has already spread to other parts of your body, being unable to have an MRI scan, or having significant bladder problems before the study starts. Certain other health conditions, like severe inflammatory bowel disease or difficulty lying flat for treatment, would also mean you can't take part.

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.

Have I been diagnosed with prostate cancer by a biopsy?
Is my cancer considered intermediate or high-risk, and hasn't spread?
Can a clear area of cancer be seen on my prostate MRI scan?
Do I have overall good health, generally able to manage daily activities?
Have I avoided recent prostate surgery or previous radiation to my pelvis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the standard brachytherapy boost or the focal brachytherapy boost, along with external beam radiotherapy. This would involve initial appointments for planning your treatment, including MRI scans and possibly other imaging to map out the prostate and cancer. The brachytherapy involves a short hospital stay for the procedure, where small radiation sources are temporarily placed in your prostate. You'll also have a course of external beam radiation treatments, typically daily for several weeks, as determined by your doctors.

Throughout the study, you will have regular follow-up appointments. These visits will involve check-ups with your doctor, blood tests (such as for PSA levels), and you'll be asked to complete questionnaires about your quality of life, especially regarding your urinary function. These questionnaires help doctors understand how your body is responding to the treatment and if there are any side effects. The total duration of your active participation, including follow-up, will be discussed by the study team, but typically involves monitoring for several years.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new or advanced treatments that may be more effective or have fewer side effects than current standard care. If you receive the focal brachytherapy, it's hoped that this more targeted approach could lead to fewer urinary problems. However, there are also potential risks involved, which are specific to the treatments being studied. These might include side effects from radiation therapy, such as changes to urinary, bowel, or sexual function. The study team will explain all known risks of both treatment arms in detail. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

London Health Sciences Centre, Verspeeten Family Cancer Centre
Verified postcode
London, Canada

Common questions

What is 'Brachytherapy'?

Brachytherapy is a type of radiation therapy where a radiation source is placed inside or very close to the body, directly at the tumour site, for a short period.

What does 'Focal' treatment mean?

'Focal' treatment means the radiation is precisely aimed at only the identified cancer area, rather than treating the entire prostate gland.

What is a 'boost' in radiation therapy?

A 'boost' means an extra, higher dose of radiation given to the cancer area, in addition to the standard radiation treatment to the prostate.

Will I know which treatment I'm getting?

Because this is a randomised trial, you will be assigned to either the standard or the focal treatment group by chance, like flipping a coin. Neither you nor your doctor will usually choose which one you receive.

What kind of side effects are you looking for?

The main focus of this study is to see how the treatments affect your urinary quality of life, meaning any changes to how often or easily you pass urine.

How to find out more

Joelle Helou, MD

joelle.helou@lhsc.on.ca 519-685-8650 Official trial record

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