RecruitingNAINTERVENTIONAL

HDR Focal: Feasibility Study

This study, called HDR Focal: Feasibility Study, is looking into treating prostate cancer. Traditionally, a treatment called brachytherapy treats the whole prostate gland. While effective, it can cause bothersome side effects like problems with urinating, bowel movements, and sexual function. This study is exploring a newer method called focal HDR brachytherapy, which aims to treat only the cancerous part of the prostate, identified using special MRI scans. The hope is that by targeting the treatment more precisely, it could reduce side effects while still effectively treating the cancer. This approach might lead to a better quality of life for men with early-stage prostate cancer.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

14 Oct 2016

Estimated completion

01 Dec 2027

Prostate Cancer

What is this study about?

This study is about exploring a new way to treat prostate cancer using a type of radiation therapy called brachytherapy. Brachytherapy involves placing tiny radioactive sources directly into the prostate gland to kill cancer cells. It's known to be a very good treatment for localised prostate cancer, meaning cancer that hasn't spread outside the prostate.

Traditionally, when brachytherapy is used, the whole prostate gland is treated. While this is effective at getting rid of the cancer, it can sometimes lead to side effects. These side effects can affect a man's quality of life, potentially causing issues with how he urinates, his bowel movements, and his sexual health. Nobody wants to experience these problems, so doctors are always looking for ways to improve treatments.

This study is focusing on a newer technique called 'focal HDR brachytherapy'. 'Focal' means concentrating the treatment on a specific area, in this case, only the cancerous part of the prostate gland. We use detailed MRI scans to help us find and target these specific areas very precisely. The main idea behind this approach is that by only treating the cancer and sparing the healthy parts of the prostate, we might be able to reduce those unwanted side effects while still being just as effective at treating the cancer. This could mean a better quality of life for men after their treatment, with fewer urinary or bowel problems and better sexual function.

Key takeaways

This study explores a new, targeted radiation treatment for prostate cancer.
The goal is to reduce treatment side effects by only treating the cancer cells.
It uses advanced MRI scans to pinpoint the exact location of the cancer.
It's for men with early-stage prostate cancer.
Potential benefits include a better quality of life after treatment.
Participation is voluntary, and involves close monitoring.

Who may be eligible?

To be considered for this study, you would need to be an adult, at least 18 years old. Doctors will check your general health to make sure you're well enough for the treatment – this is called your 'performance status'. You must have been diagnosed with prostate cancer that hasn't spread, and it should be an early stage or 'favourable intermediate risk' type of cancer. We'd also need to confirm that you don't have any medical reasons that would prevent you from having an MRI scan, as these scans are very important for guiding the treatment.

The cancer in your prostate should be small and contained, ideally with only one small area of disease, as seen on your MRI scan. Your prostate gland shouldn't be too large, and you shouldn't have significant urinary problems already. You also can't have had certain prostate procedures or radiation treatment to your pelvis or prostate in the past. There are a few other health conditions, like severe bowel diseases or certain allergies, that would mean this study isn't suitable for you. Your doctor will carefully go through all these details to see if you might be a good fit.

Remember, your doctor will need to get your full agreement and understanding of the study before you can take part. This is called 'informed consent'.

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 18 years or older?
Do you have early-stage prostate cancer that hasn't spread?
Are you able to have an MRI scan?
Do you have only one main area of cancer detected in your prostate?
Have you not had previous radiation treatment to your prostate or pelvis?
Are you generally well and healthy enough for treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors will first confirm your eligibility through various tests and scans, especially detailed MRI scans of your prostate. The core of your participation will involve receiving the focal HDR brachytherapy treatment, which is a type of internal radiation therapy. This procedure typically requires you to be under a general anaesthetic or a spinal/epidural anaesthetic for comfort. The treatment involves placing small tubes (catheters) into the prostate for a short period to deliver precise radiation doses directly to the cancerous area.

After the treatment, you'll have regular follow-up appointments. These visits will involve checks to see how you're recovering, assess any side effects, and monitor the effectiveness of the treatment. These check-ups will likely include physical examinations, blood tests, and further scans over a period of time to track your progress. The total duration of your involvement will depend on the study's follow-up schedule, which your doctor will explain in detail.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by providing a targeted prostate cancer treatment that might lead to fewer side effects compared to traditional whole-gland treatment. This could mean a better quality of life for you, with potentially less impact on your urinary, bowel, and sexual functions. However, like all medical treatments, there are potential risks involved. These could include side effects from the brachytherapy itself, such as temporary discomfort or changes to urinary or bowel habits, even with the targeted approach. There are also risks associated with the procedures, like anaesthesia, and the chance that the treatment may not be as effective for your specific cancer. It's very important to remember that participating in any clinical study is always voluntary, and you are free to withdraw at any time without affecting your future medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is brachytherapy?

Brachytherapy is a type of radiation treatment where small radioactive sources are placed inside or very close to the cancer, in this case, inside your prostate gland.

What does 'focal HDR brachytherapy' mean?

Focal means targeting only the cancerous part of the prostate, rather than the whole gland. HDR stands for 'High Dose Rate', which refers to how the radiation is delivered.

Why is this study important?

This study hopes to find a way to treat prostate cancer effectively while significantly reducing side effects like urinary or sexual problems, by targeting the treatment more precisely.

Will I have side effects if I join this study?

All cancer treatments can have side effects. While this study aims to reduce them, you might still experience some discomfort or changes to your body. Your doctors will discuss these with you.

Is this treatment available to everyone with prostate cancer?

No, this study is for specific types of early-stage prostate cancer and only for men who meet strict health and disease criteria. Your doctor will determine if you are suitable.

How to find out more

Alejandro Berlin, MD

alejandro.berlin@rmp.uhn.ca Official trial record

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