All studies
Active not recruitingPHASE2INTERVENTIONAL

Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy

This study wants to find the best way to treat prostate cancer that shows signs of returning after surgery. Some men have a rising PSA level (a marker in the blood) even after their prostate gland is removed. This trial compares two approaches: a short course of hormone treatment called degarelix given alongside radiotherapy, or just radiotherapy on its own. Researchers will follow around 122 men to see which treatment works better at keeping the cancer from coming back. The aim is to find out if adding hormone therapy for a short time improves the chances of staying cancer-free compared to radiotherapy alone.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
UNICANCER
Enrolment target
120
Start
01 Dec 2012
Estimated completion
01 Mar 2025

What is this study about?

Imagine you've had surgery to remove your prostate gland because of cancer. After the operation, doctors will regularly check your blood for a marker called PSA. If your PSA starts to go up again, it can be a sign that some cancer cells might have been left behind or have come back.

This study is looking for the best way to treat this situation. Currently, one common treatment is radiotherapy, which uses high-energy rays to kill cancer cells. This trial wants to see if adding a short course of hormone therapy, specifically a drug called degarelix (also known as Firmagon®), makes the radiotherapy even more effective. Degarelix works by reducing the amount of testosterone in the body, which prostate cancer cells often need to grow.

So, researchers will compare two groups of men: one group will receive radiotherapy on its own, and the other group will get radiotherapy combined with six months of hormone therapy. By comparing these two groups, the study hopes to find out if combining both treatments is better than just radiotherapy for preventing the cancer from returning.

Key takeaways

  • This study compares adding short-term hormone therapy to radiotherapy after prostate cancer surgery.
  • It's for men whose PSA levels are rising but are still low after surgery.
  • The goal is to see which treatment best prevents the cancer from returning.
  • One group gets radiotherapy alone, the other gets radiotherapy plus hormone therapy.
  • Both treatments involve established methods for treating prostate cancer.

Who may be eligible?

This study is looking for men who have had surgery for prostate cancer, and whose PSA levels have started to rise again after the operation but are not too high. You would need to be generally well, without signs of the cancer having spread to other parts of your body, and have healthy blood test results.

There are also some specific conditions that would prevent you from joining. For example, if your prostate cancer was a different type than common adenocarcinoma, or if you've already had radiotherapy to your pelvis, you wouldn't be able to participate. If you've had certain other serious health conditions, or if you've already been taking hormone therapy for your prostate cancer, you would also be excluded.

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.

  1. I've had surgery for prostate cancer.
  2. My PSA level has started to rise again since surgery, but it's not higher than 2 ng/mL right now.
  3. My doctors haven't found any signs that the cancer has spread.
  4. I'm generally healthy and over 18 years old.
  5. I haven't had previous radiotherapy to my pelvis or hormone therapy for this prostate cancer.
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be put into one of two treatment groups by chance, like flipping a coin. One group will receive radiotherapy to your pelvis and prostate area. The other group will get the same radiotherapy, plus you'll be given the degarelix hormone therapy for six months. You will have regular appointments and tests to check how you are responding to treatment and to monitor your health. The duration of your participation in the study, including follow-up, will be determined by the study design, but the treatment period is clearly defined.

Potential risks and benefits

Participating in a clinical trial may offer benefits like close monitoring and access to a new treatment combination. However, there are potential risks, including side effects from radiotherapy or hormone therapy like fatigue, hot flashes, or changes in blood tests, which will be fully explained to you. It's important to remember that you can decide to leave the study at any time, for any reason, without affecting your standard medical care.

Locations (39)

  • Institut de Cancérologie de l'Ouest -Site Paul Papin
    Verified postcode
    Angers, France
  • Institut Sainte Catherine
    Verified postcode
    Avignon, France
  • Chu Jean Minjoz
    Verified postcode
    Besançon, France
  • Institut Bergonié
    Verified postcode
    Bordeaux, France
  • Centre d'oncologie - Clinique Pasteur
    Verified postcode
    Brest, France
  • Centre François Baclesse
    Verified postcode
    Caen, France
  • Centre hospitalier de Chambéry
    Verified postcode
    Chambéry, France
  • Hôpital Henri Mondor
    Verified postcode
    Créteil, France
  • Centre d'oncologie et de radiothérapie du Parc
    Verified postcode
    Dijon, France
  • Centre Georges François Leclerc
    Verified postcode
    Dijon, France
  • Clinique Sainte-Marguerite
    Verified postcode
    Hyères, France
  • Chd Vendee
    Verified postcode
    La Roche-sur-Yon, France

Common questions

What is PSA?

PSA stands for Prostate-Specific Antigen. It's a protein made by the prostate, and levels in the blood can rise if prostate cancer is present or returning.

What is radiotherapy?

Radiotherapy uses high-energy rays, similar to X-rays, to kill cancer cells or stop them from growing. It's a common cancer treatment.

What is degarelix?

Degarelix is a type of hormone therapy that helps to lower testosterone levels in the body. Prostate cancer often relies on testosterone to grow.

Will I know which treatment I'm getting?

Yes, you will know if you are in the group receiving radiotherapy alone or radiotherapy plus the hormone therapy. This is not a 'blinded' study.

How long will the treatment last?

The radiotherapy typically involves a specific number of sessions. If you are in the group receiving hormone therapy, it will be for a period of six months.

How to find out more

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

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