Active not recruitingNAINTERVENTIONAL

Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.

This study is investigating a new type of radiation therapy for prostate cancer. It uses small, special implants placed inside the prostate to guide the radiation treatment more precisely. The goal is to see if this more accurate method can reduce unwanted side effects, especially those appearing later on, compared to the usual radiation methods. Doctors currently know that the prostate can move a little during treatment, so guiding the radiation more carefully might help deliver the treatment exactly where it's needed while sparing healthy tissues nearby. This study will compare patients treated with this new system to those receiving standard guided radiation.

At a glance

Status

Active not recruiting

Phase

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

Start

30 Aug 2016

Estimated completion

01 Dec 2028

Prostate Cancer

Results

Results from this study

Posted February 2025

Results have been published for this study.

Primary outcome

Assessment of Grade > 2 Late Pelvic Toxicities

assessment of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period

Full results on the registry

What is this study about?

When men are diagnosed with prostate cancer, radiation therapy is a common treatment. We know that the prostate gland can shift slightly inside the body, even during a single treatment session. This means doctors need to ensure the radiation hits the cancer effectively while protecting nearby healthy parts, like the bladder and bowel.

This study is testing a newer technology called the Calypso® System. This system involves placing tiny electronic markers, like very small beads, inside the prostate. These markers help doctors track the exact position and movement of the prostate in real-time during radiation therapy. Imagine it like a GPS for your prostate – it tells the treatment machine exactly where to aim at all times.

The main idea is that by guiding the radiation so precisely, doctors might be able to use a slightly smaller treatment area, which could reduce the risk of causing damage to healthy tissues. The study aims to find out if using this precise guidance system helps lower the chances of long-term side effects in the pelvic area after treatment, compared to current standard image-guided radiation therapy.

Key takeaways

This study compares a new radiation guiding system with standard methods.
It aims to reduce long-term side effects of prostate cancer radiation.
The Calypso system uses tiny implants to track the prostate's exact position.
Participation involves being randomly assigned to a treatment group.
The study focuses on men with low to intermediate risk prostate cancer.
You can stop participating at any time.

Who may be eligible?

This study is for men who have prostate cancer that hasn't spread to other parts of their body or to their lymph nodes. Your cancer must also be considered low or intermediate risk, based on specific tests and measurements.

To be included, you shouldn't have any major urinary or bowel problems already, and your general health should be good enough to take part. There are also some conditions that would prevent you from joining, such as having certain metal implants near the prostate (like a hip replacement or a pacemaker), a history of previous radiation to the pelvic area, or if you've already had surgery to remove your prostate or testicles.

This study is open to men between 18 and 80 years old, who are able to give their informed consent and live in France, as you'd need to be part of the French Social Security System for this trial.

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.

Do you have prostate cancer that hasn't spread?
Is your prostate cancer considered low or intermediate risk?
Are you between 18 and 80 years old?
Do you not have major metal implants like a hip replacement or pacemaker?
Have you never had radiation therapy to your pelvis before?
Are you affiliated with the French Social Security System?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups: one receiving radiation guided by the Calypso® System, and the other receiving standard guided radiation. This is like flipping a coin, so neither you nor your doctor can choose which group you're in.

Before treatment, if you're in the Calypso group, you would have small transponders (like tiny electronic beads) implanted in your prostate. You will then receive your radiation therapy sessions as planned by your medical team. You'll have regular check-ups and assessments to monitor your health and any side effects, both during and after your treatment, to understand the long-term impact. The exact number of visits and the total duration of follow-up will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study could potentially mean you receive a more precise radiation treatment, which might lead to fewer long-term side effects compared to standard care, though this is what the study aims to find out. However, there are also potential risks. The implantation procedure for the Calypso markers carries a small risk, and, like any medical treatment, radiation therapy has known side effects, some of which could appear later on. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Institut regional du Cancer - Val d Aurelle
Verified postcode
Montpellier, France

Common questions

What is 'late toxicity'?

Late toxicity means side effects that appear several months or even years after you finish your radiation treatment.

What is the Calypso® System?

It's a system that uses small implants and electromagnetic signals to accurately track the prostate's position during radiation therapy, helping guide the treatment more precisely.

Why is it important to track prostate movement?

The prostate can move slightly inside the body, so tracking its exact position helps doctors make sure the radiation hits the cancer and avoids healthy organs nearby.

Will I know which treatment group I'm in?

No, you will be randomly assigned to either the group using the Calypso system or the group getting standard guided radiation. This is to ensure fair comparison.

Can I still get treatment if I don't join the study?

Yes, declining to participate in the study will not affect your right to receive standard medical care for your prostate cancer.