RecruitingPHASE2INTERVENTIONAL

TherApeutics in Early ProState Cancer (TAPS02)

This study, called TAPS02, is for men with early prostate cancer who are currently being monitored closely (active surveillance). We're testing a drug called apalutamide, also known as Erleada, which is given as a tablet. The main goal is to see if taking this medication for a short time can be a helpful addition to active surveillance. Participants will be randomly assigned to receive either apalutamide or a dummy pill (placebo), and neither they nor their doctors will know which one they're taking. This allows us to fairly compare the effects of the drug. The study is open to men aged 18 and over who meet specific health and cancer criteria.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

Start

24 Apr 2023

Estimated completion

01 Oct 2029

Prostate Cancer

What is this study about?

Imagine you've been diagnosed with early prostate cancer, and your doctors have recommended 'active surveillance.' This means they're keeping a very close eye on your cancer without immediate treatment, only stepping in if it changes or grows. This approach is often chosen when the cancer is slow-growing and not causing symptoms.

This study is called TAPS02, and it's looking into whether adding a short course of medication could be beneficial for men like you. The drug being tested is called apalutamide, also known by its brand name Erleada. It's a tablet that works by affecting hormones that can fuel prostate cancer growth. The researchers want to understand if taking this drug for a limited time can make active surveillance even more effective.

This is a 'Phase 2' study, which means it builds on earlier research and aims to see how well the drug works and if it's safe in a larger group of people. By comparing apalutamide to a dummy pill (placebo), the doctors can get a clear picture of what effect, if any, the drug has. The information from this study could help doctors decide if this type of short-term treatment should be offered more widely to men on active surveillance in the future.

Key takeaways

This study is for men with early prostate cancer on active surveillance.
It tests a drug called apalutamide (Erleada) against a dummy pill (placebo).
Participation involves taking tablets and having regular check-ups.
The aim is to see if short-term treatment can improve prostate cancer management.
You won't know if you're getting the active drug or the placebo.
You can leave the study at any time without affecting your care.

Who may be eligible?

To join this study, you need to be a man aged 18 or older. You should already be on active surveillance for your prostate cancer, meaning your doctors are carefully watching it without giving you immediate treatment.

Your cancer needs to meet certain criteria, including showing up on an MRI scan and being confirmed by biopsies. You also need to be generally in good health, with certain blood test results within a healthy range. Importantly, you shouldn't be expected to need bladder surgery in the near future.

Your doctor will need to check your full medical history and perform some tests to make sure you fit all the requirements for the study. If you're interested, discussing it with your healthcare team is the first step.

Quick self-check

Are you a man aged 18 or older?
Are you currently on active surveillance for prostate cancer?
Has your doctor confirmed your cancer meets specific study criteria (e.g., from MRI/biopsy)?
Are you generally in good health, without major other health conditions?
Are your recent blood tests (like blood counts, kidney, and liver function) within normal limits?

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'll first be asked to sign a consent form, making sure you understand everything involved. You'll have regular hospital visits for check-ups, blood tests, and scans. You'll be given either the study drug, apalutamide, or a dummy pill (placebo) to take regularly, as prescribed by the study team. Neither you nor your doctor will know which you are receiving, which helps make the study results fair.

The study treatment period and follow-up will involve a series of appointments over a period of time. The exact number and frequency of visits will be explained by the study team, but they will be spread out to monitor your health and the progress of your cancer and to check for any side effects. You'll receive clear instructions on how to take your medication and what to expect at each appointment. The total duration of your involvement will be clearly outlined.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the study drug helps manage your prostate cancer more effectively than active surveillance alone, or it could provide valuable information that helps others in the future. However, there's no guarantee the treatment will work for you, and you might receive a dummy pill. All medicines, including apalutamide, can have side effects, and these will be carefully explained to you before you join; the study team will monitor you closely for any unwanted effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Addenbrooke's Hospital
Cambridge, United Kingdom· Recruiting
Southmead Hospital
Bristol, United Kingdom· Recruiting
West Suffolk Hospital
Bury St Edmunds, United Kingdom· Recruiting
Darent Valley Hospital
Dartford, United Kingdom· Recruiting
St Bartholomew's Hospital
London, United Kingdom· Recruiting
The Royal Marsden Hospital - Chelsea
London, United Kingdom· Recruiting

Common questions

What is 'active surveillance'?

Active surveillance means your doctors are closely watching your prostate cancer with regular tests, but not giving you immediate treatment unless it shows signs of getting worse.

What is apalutamide (Erleada)?

It's a tablet medicine that works by blocking hormones that can cause prostate cancer to grow. It's being tested to see if it can help men on active surveillance.

Will I know if I'm getting the drug or a dummy pill?

No, during the study, neither you nor your doctor will know if you're taking apalutamide or a dummy pill (placebo). This helps make the study results as accurate as possible.

What does a 'Phase 2' study mean?

A Phase 2 study checks how well a new treatment works and if it's safe for people. It's a step before potentially offering the treatment more widely.

What are the main requirements to join?

You need to be a man aged 18 or over, on active surveillance for prostate cancer that fits certain criteria, and generally in good health with specific blood test results.

How to find out more

Elizabeth Young

cuh.taps02trial@nhs.net 01223 256364 Official trial record

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