RecruitingPhase IIIInterventional

A study comparing the effect of apalutamide treatment before focal therapy with focal therapy alone in men with prostate cancer that has not spread beyond the prostate

This important study is for men with prostate cancer that hasn't spread. It compares two ways of treating this type of cancer: focal therapy on its own, versus focal therapy after a short course of medication called apalutamide. Focal therapy aims to treat only the cancerous parts of the prostate, which usually leads to fewer side effects than traditional treatments. We want to see if apalutamide, which is a hormone medicine that can shrink cancers, can improve the success of focal therapy and reduce the chance of the cancer coming back. Participants will be randomly placed into one of the two groups, and we'll follow them to see which approach works best.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Imperial College London

Enrolment target

810

Start

22 May 2026

Estimated completion

22 Mar 2027

Localised prostate cancer

What is this study about?

For men diagnosed with prostate cancer that is still contained within the prostate gland, there are different treatment options. Focal therapy is a newer approach that focuses only on treating the areas with cancer, rather than the whole prostate. This often means fewer side effects, like problems with urination or sexual function, compared to older treatments like surgery or radiotherapy which treat the entire gland.

However, sometimes after focal therapy, the cancer can return. Doctors are always looking for ways to improve these treatments. One idea is to use a medication for a short time before focal therapy. This study is looking at a drug called apalutamide, which is a hormone treatment designed to shrink prostate cancer. We believe that using apalutamide for three months before focal therapy might make the focal therapy more effective and reduce the chances of the cancer coming back, all while keeping the benefit of fewer side effects.

This study will carefully compare men who receive focal therapy alone with those who receive apalutamide for a short period before their focal therapy. By doing this, we hope to find out if this combination treatment offers a better outcome for men with localised prostate cancer.

Key takeaways

This study compares focal therapy alone with focal therapy after a short course of apalutamide for prostate cancer.
It's for men with prostate cancer that hasn't spread beyond the prostate.
The goal is to see if apalutamide can make focal therapy more effective and reduce cancer recurrence.
Participants will be randomly assigned to one of two treatment groups.
The study involves taking a drug for three months (if in that group) and then focal therapy, with follow-up appointments.
The potential benefits include improved treatment outcomes, but there are risks and side effects associated with both treatments and the drug, which will be explained in detail.

Who may be eligible?

This study is looking for men aged 18 or over who have prostate cancer that is still contained within the prostate gland and hasn't spread. You should also be planning to have focal therapy as part of your treatment plan.

There are some reasons why you might not be able to join. For example, if your cancer is too advanced for focal therapy, or if you've already had treatment for prostate cancer in the past (like previous hormone therapy, surgery, or radiotherapy). You also can't take part if you've had certain heart conditions recently or if you have a history of seizures. Your doctor will carefully check if this study is suitable for you based on all your health information and medical history.

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.

Are you a man aged 18 or older?
Do you have prostate cancer that hasn't spread outside the prostate gland?
Are you planning to have focal therapy for your prostate cancer?
Have you had previous treatment for prostate cancer (like surgery or radiation)? (If yes, you likely can't join.)
Do you have any history of seizures or recent serious heart conditions? (If yes, you likely can't join.)

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups, like flipping a coin. You won't get to choose which group you're in.

One group will have focal therapy as planned. The other group will first take apalutamide tablets (240 mg, once a day) for approximately three months (90 days), and then they'll have focal therapy. Both groups will have questionnaires to fill out during and after treatment.

After your focal therapy, you'll have check-ups every three months for the first year, and then every six months after that. You'll also have an extra prostate biopsy 6 to 12 months after your focal therapy. If the study continues to the main part, you'll be followed for up to 5 years. We'll try to arrange screening visits and follow-up in a way that fits in with your routine hospital appointments or even via phone/email where possible, so you don't have too many extra trips to the hospital. Blood tests (for PSA) can often be done at your local GP or hospital.

Potential risks and benefits

A main benefit of taking part is that the study is designed to make your hospital visits easier by combining them where possible. Also, some men find completing questionnaires about their health beneficial. For those in the apalutamide group, there's a chance that using the drug before focal therapy could make the treatment more effective than focal therapy alone. However, apalutamide has known side effects, such as tiredness, decreased sex drive, weight gain, and sometimes breast swelling or tenderness. Some men also have a higher risk of heart problems or seizures, which will be carefully monitored. Focal therapy itself, regardless of this study, carries risks like urinary problems, bowel issues, and erectile dysfunction. All these risks will be fully explained before you decide to join. You are always free to withdraw from the study at any time without affecting your standard care.

Locations (1)

Charing Cross Hospital
Approximate
London, England

Common questions

What is focal therapy?

Focal therapy is a treatment for prostate cancer that targets and treats only the cancerous parts of your prostate, leaving healthy tissue untouched where possible. This can lead to fewer side effects than treating the whole prostate.

What is apalutamide?

Apalutamide is a hormone medicine that works by blocking the effects of testosterone, which can encourage prostate cancer growth. It's used here to see if it can shrink the cancer before focal therapy.

Will I have to have extra hospital visits?

We aim to combine your study visits with your routine hospital appointments where possible. Some follow-up can even be done by phone or email, as long as you get your blood tests done and complete questionnaires.

How long will I be involved in the study?

For the first part of the study, you'll be followed for at least 12 months. If the study continues, you could be followed for up to 5 years.

Who is paying for this study?

Janssen Cilag Ltd, the company that makes apalutamide, is funding the first stage of the study and providing the medication free of charge.

How to find out more

Amalia Ndoutoumou

rgit.ctimp.team@imperial.ac.uk +44 20 75941862 Official trial record

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