RecruitingNAINTERVENTIONAL

Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

This research is looking into new ways to treat prostate cancer using radiation. Traditionally, radiation is given in small doses over many weeks. This study compares two types of 'hypofractionated' radiation, which means fewer, larger doses. One is called 'ultra-hypofractionated' (UH) and the other is 'moderately hypofractionated' (MH). Both methods are combined with brachytherapy, which is internal radiation delivered directly to the prostate. The main goal is to see if the faster UH treatment has similar side effects to MH. Researchers will also check how well patients tolerate the treatment, any immediate or long-term side effects, and how effective it is in controlling the cancer over 5 and 10 years. It aims to make radiation therapy more convenient and potentially just as safe and effective.

At a glance

Status

Recruiting

Phase

Sponsor

CHU de Quebec-Universite Laval

Enrolment target

205

Start

01 Apr 2014

Estimated completion

01 Dec 2033

Prostate Cancer Radiotherapy Side Effect Hypofractionation Brachytherapy Radiotherapy Localized Prostate Carcinoma

What is this study about?

This study is designed to find out the best way to give radiation therapy for prostate cancer. For a long time, traditional radiation involved many small doses over several weeks. However, doctors are now exploring 'hypofractionated' radiation, which means giving fewer but stronger doses over a shorter period. This could make treatment more convenient for patients.

Specifically, this research compares two types of hypofractionated radiation. One is called 'ultra-hypofractionated' (UH) therapy, which is the fastest schedule, and the other is 'moderately hypofractionated' (MH), which is a slightly longer schedule, but still quicker than traditional radiation. Both of these external radiation treatments are combined with 'brachytherapy,' which is a type of internal radiation where tiny radioactive sources are placed inside the prostate to directly target the cancer. The main goal is to see if the faster 'ultra-hypofractionated' approach has similar side effects to the 'moderately hypofractionated' one. Researchers want to make sure the quicker treatment is just as safe when it comes to any problems or discomfort patients might experience.

The study will also look at other important things: how well patients can cope with the treatment, any immediate side effects that happen during or shortly after treatment, and any long-term side effects that might appear months or years later. Beyond just side effects, the study will track how well the treatments control the cancer, specifically looking at how many patients remain free of cancer progression after 5 and 10 years. This comprehensive approach helps doctors understand both the safety and effectiveness of these modern radiation techniques.

Key takeaways

Compares two types of faster radiation for prostate cancer.
Combines external radiation with internal brachytherapy.
Aims to find out if faster treatment has similar side effects.
Monitors immediate and long-term side effects.
Tracks cancer control over 5 and 10 years.
Study recruitment ended in June 2023.

Who may be eligible?

This study is for men aged 18 to 95 who have prostate cancer that has been confirmed by a biopsy. Your cancer needs to be at an early stage (T1c or T2) and must not have spread to nearby lymph nodes or other parts of your body (N0 or M0). Your PSA level, which is a blood test for prostate cancer, should be less than 20 ng/ml, and your Gleason Score, which describes how aggressive your cancer looks under a microscope, should be 6 or 7. You also need to be able to understand the study and agree to take part by signing a consent form.

There are certain reasons why you wouldn't be able to join. These include if your cancer is more advanced (stages T3 or T4, or has spread to lymph nodes N1, or other parts of the body M1). If your PSA is higher than 20, or your Gleason Score is higher than 7 (8-10), you wouldn't be eligible. Also, if you've previously had radiation therapy to your pelvis, or have certain conditions like inflammatory bowel disease (like Crohn's disease or ulcerative colitis) or specific autoimmune diseases, you can't participate. Having severe urinary symptoms or bilateral hip replacements would also prevent you from joining.

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 aged 18 to 95?
Do you have prostate cancer confirmed by a biopsy?
Is your cancer early-stage (T1c or T2) and hasn't spread?
Is your PSA level below 20 ng/ml and Gleason Score 6 or 7?
Have you NOT had previous pelvic radiation?
Do you NOT have severe inflammatory bowel disease or certain autoimmune conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first undergo a procedure called brachytherapy. This involves inserting tiny radioactive sources into your prostate. This is done while you are asleep under general or spinal anaesthetic. During this procedure, a thin tube (Foley catheter) might be temporarily placed in your bladder, and fiducial markers (small gold seeds) will be put into your prostate to help guide radiation later. You will also have imaging scans like TRUS (ultrasound) or CT scans to help plan your treatment.

About one week after the brachytherapy, you will start external radiation therapy. This will be given in 5 sessions over a period of 7 days, usually with a break over the weekend. These sessions will use advanced techniques like IMRT, VMAT, or SBRT to target the cancer precisely. You'll have further scans, including a CT scan and potentially an MRI, to help your doctors plan and deliver the radiation accurately. After your treatments, you'll have regular follow-up appointments to monitor your recovery, check for any side effects, and see how well the treatment has worked over 5 and 10 years. The study started in December 2015 and stopped recruiting new patients in June 2023.

Potential risks and benefits

Participating in this study might offer you benefits such as receiving advanced prostate cancer treatment and contributing to medical knowledge that could help future patients. However, like all medical treatments, there are potential risks, primarily side effects from the radiation, which will be monitored closely. These could include urinary or bowel changes, or fatigue. Your doctors will explain these risks in detail. It’s important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

CHUdeQuebec
Verified postcode
Québec, Canada· Recruiting

Common questions

What is 'hypofractionated' radiation?

It's a type of radiation therapy where you receive fewer, but larger, doses of radiation over a shorter period compared to traditional methods.

What is 'brachytherapy'?

Brachytherapy is a type of internal radiation where tiny radioactive sources are placed directly into the prostate to target the cancer from the inside.

What kind of side effects are they looking for?

The study will compare side effects between two groups of patients, looking at both immediate and long-term issues related to the radiation, such as urinary or bowel problems.

How long will the total treatment take?

After brachytherapy, the external radiation therapy will be given in 5 sessions over 7 days.

Will I have follow-up after the treatment?

Yes, you will have follow-up for 5 and 10 years to see how well the treatment worked and to monitor any long-term effects.

How to find out more

Andre-Guy Martin

andre-guy.martin.med@ssss.gouv.qc.ca 14186915264 Official trial record

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