Active not recruitingPHASE3INTERVENTIONAL

Comparison of HDR vs. LDR Brachytherapy as Monotherapy for Intermediate Risk Prostate Cancer

This study is for men with a specific type of prostate cancer called 'intermediate risk' who are thinking about having radiation treatment directly in the prostate (brachytherapy). Researchers want to compare two ways of doing brachytherapy: Low Dose Rate (LDR) and High Dose Rate (HDR). LDR uses tiny radioactive seeds left permanently, while HDR uses a temporary high-dose radiation source. The main goal is to find out if one method leads to better quality of life regarding bladder and bowel function, and if recovery is quicker. They also want to understand if these benefits are still there when brachytherapy is used as the only treatment, without additional external radiation.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

British Columbia Cancer Agency

Enrolment target

Start

01 May 2016

Estimated completion

01 Apr 2026

Prostate Cancer

What is this study about?

This study is looking at two different ways to give radiation treatment for prostate cancer, specifically for men with what doctors call 'intermediate-risk' prostate cancer. Both treatments, called brachytherapy, involve placing radioactive sources directly into the prostate gland.

One type is called Low Dose Rate (LDR) brachytherapy. This is where tiny radioactive seeds are permanently placed in your prostate. These seeds slowly release radiation over several months. It's a common treatment, but sometimes the recovery can take a while, especially for bladder (urinary) side effects, which might last for 6 to 12 months. This is partly because the radiation is given out slowly over a long time, and the exact placement of the seeds can sometimes be a bit tricky.

The other type is High Dose Rate (HDR) brachytherapy. With this method, a stronger dose of radiation is given over a much shorter time, usually about 15-20 minutes, and then the radioactive source is removed. Doctors think HDR might lead to fewer side effects and a quicker recovery because the treatment is faster and they can control where the radiation goes more precisely. This trial wants to see if these potential benefits of HDR translate into a better quality of life for men when it's used as the main treatment, compared to LDR. Understanding this could help doctors recommend the best treatment for men with intermediate-risk prostate cancer.

Key takeaways

Compares two types of internal radiation (brachytherapy) for prostate cancer.
Aims to find out if one treatment (LDR vs. HDR) causes fewer bladder/bowel issues.
Suitable for men with 'intermediate-risk' prostate cancer.
Participation involves being randomly assigned to one of the two treatments.
Closely monitors your health and quality of life after treatment.
Could help improve future prostate cancer treatment choices.

Who may be eligible?

This study is designed for men, aged between 40 and 80, who have been diagnosed with certain types of prostate cancer that doctors classify as 'intermediate risk'. Generally, this means your cancer hasn't spread beyond the prostate, your PSA level is below 20, and your Gleason score is less than 8. You should be generally fit and well enough for treatment.

There are also some specific conditions about your prostate cancer that must be met. For example, the overall size of your prostate must be within a certain limit. Also, you shouldn't have had any hormone therapy recently. The doctors will check all these details carefully to make sure the study is right for you. They will also want to make sure you are not suitable for or interested in just watching your cancer closely (called 'active surveillance').

You wouldn't be able to join this study if you've had previous major prostate surgery for cancer, had radiation to your pelvis before, or if you've already had chemotherapy for prostate cancer. Also, if you've had a procedure called a TURP or prostate cryosurgery, or if you can't have an MRI scan, this study might not be suitable.

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 between 40 and 80 years old?
Have you been diagnosed with 'intermediate-risk' prostate cancer?
Is your PSA level less than 20 and Gleason score less than 8?
Have you NOT had major prostate cancer surgery, pelvic radiation, or chemotherapy before?
Is your prostate size within acceptable limits?
Are you able to have an MRI scan?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either LDR or HDR brachytherapy, like flipping a coin for which treatment you get. After your treatment, you'll have regular follow-up appointments where doctors will ask you questions about your health and how you're feeling, especially about your bladder and bowel function. These questions might be asked through questionnaires. You'll also have tests and scans to monitor your prostate cancer and check for any side effects. The exact number of visits and the full duration of follow-up will be explained by the study team, but these types of studies often involve monitoring over several years to understand the long-term effects of the treatments.

Potential risks and benefits

Taking part in this study means you'll receive either LDR or HDR brachytherapy, both of which are standard treatments for prostate cancer. Potential benefits include helping doctors understand which treatment works best with the fewest side effects, which could improve care for future patients. For you personally, you will receive expert care and close monitoring of your condition. However, like all medical treatments, there are potential risks and side effects associated with both LDR and HDR brachytherapy, such as urinary, bowel, and sexual side effects, which the study team will discuss in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

British Columbia Cancer Agency Center for the Southern Interior
Verified postcode
Kelowna, Canada

Common questions

What is brachytherapy?

Brachytherapy is a type of radiation treatment for prostate cancer where radioactive material is placed directly inside your prostate gland.

What's the difference between LDR and HDR brachytherapy?

LDR uses tiny seeds left in your prostate permanently over months, while HDR gives a stronger dose of radiation temporarily over a short time, usually about 15-20 minutes, then the source is removed.

Why is this study comparing these two treatments?

The study wants to find out if one treatment causes fewer bladder and bowel problems and helps you recover faster when used as the only treatment for prostate cancer.

Will I get to choose which treatment I receive?

No, if you join the study, you'll be randomly assigned to either the LDR or HDR group, like drawing lots, to ensure a fair comparison.

What does 'intermediate-risk prostate cancer' mean?

It's a way doctors classify prostate cancer, meaning it's less aggressive than some high-risk cancers but more so than very low-risk ones. Your doctor can explain your specific situation.