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EvaluatioN of High-Intensity Focused Ultrasound (HIFU) Hemi-ablation and short-term AndrogeN deprivation therapy Combination to Enhance prostate control for intermediate risk localized prostate cancer: the ENHANCE prospective feasibility trial

The ENHANCE study is testing a combined treatment approach for men with intermediate-risk prostate cancer that has not spread. Standard treatments, such as surgery or radiotherapy, treat the entire prostate but can sometimes cause long-term urinary or sexual problems. In this trial, doctors are testing high-intensity focused ultrasound (HIFU) to destroy cancer cells on one side of the prostate using heat. Alongside this, patients receive a short course of hormone therapy called Eligard. This temporary injection lowers testosterone to help weaken the cancer cells. The study aims to find out if this combined approach successfully controls the cancer after 12 months. Researchers will also closely monitor side effects, checking how well it preserves erectile function, bladder control, and general quality of life compared to whole-gland treatments.

At a glance

Status
Recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Institut Mutualiste Montsouris
Enrolment target
20
Start
25 Oct 2024
Intermediate risk prostate cancer

What is this study about?

Prostate cancer is the most common cancer in UK men. For men with 'intermediate-risk' prostate cancer, the tumour is still contained within the prostate gland, but it usually requires active treatment to stop it from growing or spreading. Traditional options include removing the entire prostate gland with surgery or treating it with full radiotherapy. While these treatments are effective, they can sometimes damage nearby nerves and tissues, leading to lasting issues with bladder control and erections.

To reduce these side effects, doctors have developed 'focal' treatments like High-Intensity Focused Ultrasound (HIFU). HIFU uses targeted sound waves to heat up and destroy only the diseased area of the prostate, leaving the healthy tissue unharmed. In this study, doctors are focusing on 'hemi-ablation', which means treating one side of the prostate where the cancer is located.

This trial is testing whether adding a short course of hormone therapy (an injection called Eligard) makes the HIFU treatment work even better. The hormone medicine temporarily lowers testosterone levels, which starves the cancer cells and may make them easier to destroy. The main goal is to see how many men remain free of significant cancer 12 months later, while maintaining their normal day-to-day quality of life.

Key takeaways

  • The ENHANCE study tests a combination of targeted ultrasound (HIFU) and short-term hormone therapy.
  • It is designed for men with intermediate-risk prostate cancer that has not spread.
  • The goal is to destroy the cancer while reducing side effects on erections and bladder control.
  • Participants are followed up closely for at least 12 months with blood tests, scans, and questionnaires.
  • Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adult men aged 18 and older who have been diagnosed with localized, intermediate-risk prostate cancer. 'Localized' means that scans show the cancer is contained within the prostate and has not spread to other parts of the body.

To take part, the cancer must be suitable for targeted treatment on one side of the prostate. Your medical team will look closely at your biopsy results, PSA blood test levels, and MRI scans to decide if your cancer fits into this intermediate-risk group.

Men who have already had certain previous treatments for prostate cancer, or those whose cancer has spread outside the gland, will likely not be eligible. Your hospital doctor or research nurse can check your full medical records to see if this trial matches your exact condition.

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 am a man aged 18 or older.
  2. I have been diagnosed with intermediate-risk prostate cancer.
  3. My cancer is localized, meaning it has not spread outside the prostate.
  4. My doctor believes my cancer is suitable for targeted treatment on one side of the prostate.
  5. I am willing to attend regular hospital check-ups and complete quality-of-life surveys over 12 months.
Answer every question to see your result.

What does participation involve?

If you decide to take part, your care will be planned over at least 12 months. At the start, you will receive an injection of Eligard (a hormone medicine) under the skin. You will then have the HIFU procedure, which is performed under general anaesthetic using a small probe that delivers ultrasound heat directly to the targeted part of your prostate.

After treatment, you will attend hospital follow-up visits at 1, 3, 6, and 12 months. At these visits, you will have routine blood tests to check your PSA (prostate-specific antigen) and testosterone levels.

You will also be asked to fill out short questionnaires about your bladder control, urinary flow, erections, and general well-being. At the 12-month mark, you will have checks—such as an MRI scan or follow-up biopsy—to see if any cancer remains in the prostate.

Potential risks and benefits

A potential benefit of this treatment is that it targets only the cancerous part of the prostate, which may reduce the chance of long-term bladder leakage or erection problems compared to major surgery. However, there is no guarantee that the treatment will clear all of the cancer, and some men may still need further cancer therapy later. Possible risks include temporary side effects from the hormone injection, such as hot flushes, tiredness, or mood changes. The ultrasound treatment can also cause short-term urinary discomfort, swelling, or difficulty passing urine. Taking part is completely voluntary, and you are free to leave the trial at any time without your regular NHS care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    France

Common questions

What is HIFU and how does it work?

HIFU stands for High-Intensity Focused Ultrasound. It uses high-frequency sound waves focused tightly on cancer cells. This creates precise heat that destroys the targeted tissue while aiming to spare the healthy parts of the prostate around it.

Will the hormone injection cause permanent side effects?

No, the hormone therapy in this study is short-term. While your testosterone levels are low, you might notice temporary side effects like hot flushes or reduced sex drive, but these typically wear off as the medication leaves your body.

Is this a standard NHS treatment?

HIFU is available in some specialist centres, but combining it with this specific short course of hormone therapy is still being researched. This trial helps doctors find out if the combination is safe and effective.

What happens if the cancer comes back after 12 months?

You will be monitored very closely. If any significant cancer is found during your follow-up tests, your care team will discuss standard options with you, such as surgery, radiotherapy, or further focal therapy.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point without giving a reason. Your doctors will continue to offer you the best standard treatment options available.

How to find out more

Official trial record

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

Interested in taking part?

Register your interest

Share your details and the research team for "EvaluatioN of High-Intensity Focused Ultrasound (HIFU) Hemi-…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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