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RecruitingNAINTERVENTIONAL

Focal Therapy for Prostate Cancer Using HIFU

This study explores a focused treatment called High-Intensity Focused Ultrasound (HIFU) for prostate cancer. Unlike surgery or radiation that treat the whole prostate, HIFU targets only the cancerous areas. The goal is to control the cancer effectively while significantly lowering the risk of common side effects, such as problems with erections (erectile dysfunction) and bladder control (urinary incontinence). Previous smaller studies have shown promising results with many men keeping good sexual and bladder function alongside cancer control. This larger study wants to confirm these findings in a more diverse group of men with prostate cancer, helping us understand if it's a good option for more people.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University College, London
Enrolment target
354
Start
29 Jun 2011
Estimated completion
01 Jun 2029

What is this study about?

This research is looking at a new way to treat prostate cancer called High-Intensity Focused Ultrasound, or HIFU for short. This treatment is very precise – think of it like using a magnifying glass to focus sunlight. HIFU uses sound waves to heat and destroy only the cancer cells in your prostate, leaving the healthy parts untouched as much as possible.

Traditional treatments for prostate cancer often involve removing the whole prostate or treating it with radiation. While these are effective, they can sometimes lead to side effects like difficulty getting or keeping an erection, or problems controlling your bladder. The idea behind HIFU is to offer a treatment that controls the cancer effectively, but with much fewer side effects, so men can maintain a good quality of life.

We know from smaller studies that HIFU shows good promise in controlling cancer and also helping men avoid these side effects. However, these studies were done on a select group of men. This new study aims to include a wider range of men with prostate cancer to see if these promising results hold true for more people. This will help us understand if HIFU could be a good option for many more men diagnosed with prostate cancer in the future.

Key takeaways

  • This study evaluates HIFU, a new targeted treatment for prostate cancer.
  • HIFU aims to destroy cancer cells while preserving healthy tissue.
  • The goal is fewer side effects like erection and bladder problems.
  • You'll have various tests and follow-ups to monitor treatment success.
  • The study seeks to confirm benefits seen in smaller groups for a wider patient range.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with prostate cancer. This diagnosis must be confirmed by prostate biopsies, which are tissue samples taken from your prostate.

Your cancer should be contained within your prostate, usually described as stages T1 to T2c, and shouldn't have spread to other parts of your body. Also, your PSA level (a blood test for prostate health) should be 20 or less. You should also be healthy enough to expect to live for at least another 10 years and be able to understand study information in English.

Specifically, your biopsy results would need to show cancer that is mainly in one part of the prostate (unilateral) or mostly on one side (bilateral, but with only a small amount of significant cancer on the non-dominant side), fitting certain grading criteria like Gleason 3+3, 3+4, or 4+3, but not more aggressive types. Your MRI scans should also match these findings.

Quick self-check
  • Have you been diagnosed with prostate cancer confirmed by biopsy?
  • Is your prostate cancer contained within the prostate and hasn't spread?
  • Is your PSA level 20 or less?
  • Do you expect to live for at least 10 more years?
  • Do your biopsy results match the specific criteria for cancer type and location?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you might have various assessments before, during, and after your HIFU treatment. These could include filling out questionnaires about your health and daily life, having blood tests to check your PSA levels, and undergoing imaging scans like MRI to monitor your prostate. You would also have regular check-ups to assess any side effects or how well the treatment is working.

The HIFU treatment itself involves directing high-intensity sound waves to destroy the cancerous cells. After the treatment, there will be follow-up appointments and tests, including prostate biopsies, to make sure the cancer is controlled and to keep an eye on any potential problems. The total length of your participation is not specified but it is described as a 'medium term follow-up' to carefully track your progress over time.

Potential risks and benefits

Taking part in this study may offer the potential benefit of a targeted prostate cancer treatment (HIFU) that aims to control cancer with fewer side effects, such as erection difficulties and urinary problems, compared to traditional treatments. However, like all medical treatments, HIFU carries potential risks, including the possibility that the treatment might not completely remove all cancer, or that you could still experience some side effects, though hopefully less severe. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • University College London
    London, United Kingdom· Recruiting

Common questions

What is HIFU?

HIFU stands for High-Intensity Focused Ultrasound. It's a treatment that uses powerful sound waves to heat and destroy cancer cells in a very precise way, without needing cuts or surgery.

Will HIFU cure my prostate cancer?

The goal of HIFU is to effectively control the prostate cancer. This study is researching how well it works and aims to reduce the severity of side effects compared to traditional treatments.

Are there any side effects from HIFU?

As with any treatment, there can be side effects. The aim of this focal (targeted) HIFU treatment is to reduce common side effects like erection problems and bladder control issues, but some side effects may still occur.

How long will I be involved in the study?

The study involves 'medium term follow-up', meaning you would be monitored for a period of time after your treatment to track your progress and any effects.

Do I have to do anything special to prepare for HIFU?

Specific preparation details would be discussed with you by the study team, but generally, you'll have various checks and scans beforehand to plan the treatment precisely.

How to find out more

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 "Focal Therapy for Prostate Cancer Using HIFU…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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