All studies
Active not recruitingNAINTERVENTIONAL

Comparison of Intermittent Androgen Deprivation Therapy With or Without Irradiation Recovery in Prostate Cancer Patients

This study is for men with prostate cancer that has spread a small amount (up to five spots) to their pelvic lymph nodes, known as 'oligometastatic' disease. Traditionally, advanced prostate cancer aimed to slow its growth, not cure it. However, new scanning methods can find these small areas of spread, leading doctors to wonder if they can be treated more aggressively. This study will compare two approaches: hormone therapy given in cycles (called intermittent androgen deprivation therapy, or IADT), versus the same hormone therapy combined with targeted radiation to the affected area. The goal is to see if adding radiotherapy can help prevent the cancer from growing back sooner, extending the time before another round of treatment is needed.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
Institut Cancerologie de l'Ouest
Enrolment target
256
Start
04 Dec 2018
Estimated completion
01 Jun 2026

What is this study about?

This study is designed for men who have prostate cancer that has spread a little bit, usually to fewer than five spots in the pelvic area. This specific type of spread is called 'oligometastasis'. In the past, if prostate cancer spread, the main focus was on managing the disease and slowing its progress, rather than trying to get rid of all the cancer. However, with improved scans that can find these small areas of spread earlier, doctors are now investigating if more focused treatments could be helpful.

The main idea behind this study is that men with these limited areas of spread might benefit from stronger, more targeted treatments. This study is exploring if adding radiotherapy (a treatment that uses high-energy beams to kill cancer cells) to standard hormone therapy can keep the cancer from coming back for a longer time. The hormone therapy used in this study is given in cycles, meaning you'll take it for a period, then stop, and potentially restart if needed.

By comparing these two treatment approaches – hormone therapy alone versus hormone therapy plus radiotherapy – researchers hope to find out if combining treatments can significantly delay the cancer's return and improve the time someone spends without needing further treatment. This could be an important step forward for men with this specific type of prostate cancer.

Key takeaways

  • The study helps men with a small number of prostate cancer spreads (oligometastasis) in their pelvis.
  • It compares hormone therapy alone vs. hormone therapy plus targeted radiotherapy.
  • The main goal is to see if combined treatment delays cancer's return.
  • New, sensitive scans are used to find these small cancer spots.
  • Participation involves different treatments, regular check-ups, and monitoring.

Who may be eligible?

This study is looking for men who have prostate cancer that has been confirmed by a biopsy. You must be at least 18 years old and generally healthy enough to participate in a study of this kind. You should have already received previous treatment for your prostate cancer, such as surgery or main radiotherapy.

For this study, the cancer can only have spread to a small number of lymph nodes in your pelvis (five or fewer), and these would have been found using special scans like FCH-PET or PSMA-PET. These spread spots must be in the lower part of your body, around your pelvis, not higher up or in your bones or other organs. If you’ve had hormone therapy before, it needs to have been at least a year ago, and your testosterone levels must have recovered to a certain point.

You also need to have what doctors call a 'biochemical relapse', which means your PSA (Prostate Specific Antigen) blood test levels have started to rise again after your previous treatment, indicating the cancer may be returning or growing. You must be willing to follow all study instructions, attend appointments, and understand and sign an informed consent form. If you have a partner who could become pregnant, you'll need to use effective birth control during and for 12 months after the study treatment.

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. Have you had a confirmed prostate cancer diagnosis?
  2. Have you already had treatment for your prostate cancer, such as surgery or radiotherapy?
  3. Do your recent scans (like PET scans) show 5 or fewer spots of cancer spread, only in your pelvic lymph nodes, not in bones or other organs?
  4. Has your PSA level started to rise again after your previous treatment?
  5. If you previously had hormone therapy, was it more than a year ago, and have your testosterone levels recovered?
  6. Are you willing and able to attend all study appointments and follow the treatment plan?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is a screening process to make sure you're suitable, which can happen up to three months before your treatment starts. Once you've given your written permission, you'll be randomly assigned to one of two groups. Neither you nor your doctor will get to choose which group you're in, similar to flipping a coin.

Both groups will receive the first dose of a hormone therapy called IADT on the day you're assigned to a group. This hormone therapy will last for six months in total. If you are in the group that also gets radiotherapy, you'll start that treatment about three months after your first hormone injection. The radiotherapy itself will also last for about three months. After the six-month treatment period, if your cancer hasn't worsened and your PSA level is low enough, you'll enter a non-treatment phase.

During this non-treatment phase, your PSA levels will be monitored. If your PSA starts to rise, you'll have regular scans every six months to check for any cancer progression. The study involves regular visits for blood tests, check-ups, and potentially scans. The total duration of your participation will depend on how your cancer responds.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving close medical monitoring and access to a potentially more effective combined treatment approach (hormone therapy plus radiotherapy) that could delay your cancer's progression. However, like all medical treatments, there are potential risks associated with both hormone therapy and radiotherapy, which your doctor will discuss in detail. Side effects can include fatigue, hot flashes from hormone therapy, and skin changes or bowel issues from radiotherapy, among others. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

  • Institut Sainte Catherine
    Verified postcode
    Avignon, France
  • Institut Bergonie
    Verified postcode
    Bordeaux, France
  • CHRU de Brest
    Verified postcode
    Brest, France
  • Clinique Pasteur
    Verified postcode
    Brest, France
  • Institut de Cancérologie de Bourgogne
    Verified postcode
    Chalon-sur-Saône, France
  • Centre Jean Perrin
    Verified postcode
    Clermont-Ferrand, France
  • Centre Georges François Leclerc
    Verified postcode
    Dijon, France
  • Centre Oscar Lambret
    Verified postcode
    Lille, France
  • Centre Léon Bérard
    Verified postcode
    Lyon, France
  • Institut de Cancérologie de Montpellier
    Verified postcode
    Montpellier, France
  • Centre Azureen de Cancerologie
    Verified postcode
    Mougins, France
  • Institut de Cancérologie
    Verified postcode
    Nantes, France

Common questions

What does 'oligometastasis' mean?

It means your prostate cancer has spread to a very limited number of spots, typically five or fewer, in areas like your lymph nodes, but not widely throughout your body.

What is 'intermittent androgen deprivation therapy' (IADT)?

It's a hormone therapy for prostate cancer given in cycles – you take it for a period, then stop, and restart if needed, rather than taking it continuously.

Why are they comparing two treatments?

Researchers want to see if adding targeted radiotherapy to the hormone therapy will help keep the cancer under control for a longer time compared to hormone therapy alone.

What kind of scans are used?

Special scans like FCH-PET or PSMA-PET are used to find these small areas of cancer spread that might not show up on standard scans.

Will I know which treatment I'm receiving?

You will be told that you are either in the experimental group (hormone therapy plus radiotherapy) or the control group (hormone therapy alone) once you are assigned.

How to find out more

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

Discussion

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