Active not recruitingPHASE3INTERVENTIONAL

Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients

This study is for men with prostate cancer that has spread to a few other parts of the body, but is still affected by hormones. It's called 'oligometastatic hormone-sensitive prostate cancer'. Researchers want to see if adding a special type of focused radiation, called Stereotactic Body Radiotherapy (SBRT), to these small new cancer spots helps more than just the usual hormone treatment. SBRT delivers high doses of radiation very precisely to the cancer sites, aiming to destroy them. The study is in its final phase (Phase 3) and involves comparing two groups of patients: one getting standard care and the other getting standard care plus SBRT to their cancer spots. The main goal is to find out if this focused radiation improves treatment outcomes.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

UNICANCER

Enrolment target

550

Start

23 Jun 2020

Estimated completion

28 Feb 2031

Oligometastatic Hormone Sensitive Prostate Cancer

What is this study about?

Imagine you have prostate cancer, and doctors have found a small number of new cancer spots in other parts of your body. This is called 'oligometastatic' cancer, and it means the cancer hasn't spread widely. Because your cancer is 'hormone-sensitive,' it means its growth is affected by hormones, so hormone therapy is a key part of your treatment. This study is exploring a new approach for people like you.

The main idea behind this study is to see if adding a very precise type of radiation, called Stereotactic Body Radiotherapy (SBRT), to these few new cancer spots, makes your treatment more effective. SBRT is like a highly targeted beam that delivers a strong dose of radiation directly to the cancer, trying to destroy it, while sparing healthy surrounding tissue as much as possible. This study is comparing what happens when people receive standard hormone treatment alone versus standard hormone treatment plus this special SBRT.

Researchers hope that by treating these individual cancer spots directly with SBRT, alongside standard hormone therapy, it might lead to better control of the cancer and better outcomes for patients. This is an important step in figuring out the best way to help men with this specific type of prostate cancer.

Key takeaways

This study compares standard hormone therapy with adding focused radiation (SBRT) for prostate cancer that has spread to a few spots.
It's for men aged 18+ whose cancer is still affected by hormones and has up to 5 small spread sites.
SBRT aims to precisely destroy these new cancer spots.
Participants will be randomly assigned to one of two treatment groups.
The main goal is to see if SBRT improves cancer control.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be a man aged 18 or older with prostate cancer that has been confirmed by a biopsy. Your cancer needs to have spread to a small number of places in your body (up to 5 spots, which might include bones, certain lymph nodes, or lungs), but not widely. These spots should not be causing you significant pain or symptoms.

Your doctors must have recently identified these new cancer spots using special scans like PET/CT or MRI, before you started hormone therapy. You can join even if you've had prostate surgery or radiation before, as long as there's no active cancer in those treated areas. You also need to be well enough to manage daily activities.

You should be suitable for long-term hormone therapy, and if you've already started it, it must have been within the last two months. If you can't take certain other cancer drugs like docetaxel or abiraterone, you might still be able to join. All participants must agree to use effective birth control during the study and for six months afterwards.

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.

I am a man aged 18 or older.
I have prostate cancer confirmed by a biopsy.
My cancer has spread to a small number of places (up to 5 spots).
My cancer is 'hormone-sensitive' (meaning hormone therapy is suitable).
I'm generally well enough for daily activities (ECOG score of 0, 1, or 2).
I agree to use effective contraception if needed.

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, like flipping a coin. One group will receive the usual hormone therapy for your prostate cancer. The other group will also receive the usual hormone therapy, but in addition, they will have the special focused radiation treatment (SBRT) directed at all their identified cancer spots. The SBRT itself involves a few short treatment sessions.

You will have regular check-ups, scans, and blood tests as part of your normal cancer care, which will also help the study doctors monitor your progress. The study aims to follow your health over a longer period to understand the long-term effects of these treatments. The total duration of your active involvement might be several years, depending on how your treatment progresses and the long-term follow-up plan.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer monitoring of your cancer. If you receive the SBRT, it might help control your cancer more effectively than standard treatment alone, though this is what the study aims to find out. Potential risks of SBRT can include side effects related to the area being treated, such as fatigue or temporary irritation, which your doctors will discuss fully. It's important to remember that side effects can vary. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (35)

Institut Sainte Catherine
Verified postcode
Avignon, France
Institut Bergonié
Verified postcode
Bordeaux, France
Centre d'oncologie - Clinique Pasteur
Verified postcode
Brest, France
CHRU de Brest
Verified postcode
Brest, France
Centre François Baclesse
Verified postcode
Caen, France
Centre Jean Perrin
Verified postcode
Clermont-Ferrand, France
Centre Amethyst de Creil
Verified postcode
Creil, France
Centre Hospitalier Intercommunal de Créteil
Verified postcode
Créteil, France
Institut de cancérologie de Seine et Marne - Clinique de Jossiny
Verified postcode
Jossigny, France
Centre Oscar Lambret
Verified postcode
Lille, France
Groupe Hospitalier Bretagne Sud
Verified postcode
Lorient, France
Centre Leon Berard
Verified postcode
Lyon, France

Common questions

What does 'oligometastatic' mean?

It means your cancer has spread to a few (typically up to 5) new, small spots in your body, rather than widely.

What is 'hormone-sensitive prostate cancer'?

It means your prostate cancer's growth is affected by hormones, so hormone therapy is an effective treatment for it.

What is SBRT?

SBRT, or Stereotactic Body Radiotherapy, is a very precise type of radiation that delivers high doses to cancer spots while trying to protect healthy tissue nearby.

Will I definitely get the SBRT treatment if I join?

No, you will be randomly placed into one of two groups: one gets standard care, and the other gets standard care plus SBRT. It's like a scientific coin toss.

How long will I be involved in the study?

Active participation might last several years, with regular check-ups and monitoring to see how the treatments work in the long term.