Active not recruitingNAINTERVENTIONAL

Prostate Cancer Active Surveillance Trigger Trial (PCASTT-UK): Comparing Current Practice for Men With Prostate Cancer on Active Surveillance (AS) to an AS Protocol With Standardised Triggers for Transitioning to Curative Treatment

This study, called PCASTT-UK, is for men with prostate cancer who are currently on active surveillance. Active surveillance means closely watching the cancer without immediately starting treatment. The main idea is that some prostate cancers grow very slowly and might not need treatment right away, avoiding side effects from unnecessary procedures. However, it's often unclear exactly when to switch from watching the cancer to starting treatment. This trial compares the current way doctors decide (which can vary) with a new, more standardised plan. This new plan uses clear guidelines, like changes seen on MRI scans or blood test results, to decide when to do more tests or start curative treatment. By comparing these two approaches, the study hopes to reduce unneeded treatments and their side effects, while making sure the cancer is still managed effectively and doesn't get worse. It’s part of a larger international effort to improve prostate cancer care.

At a glance

Status

Active not recruiting

Phase

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

195

Start

19 Sep 2019

Estimated completion

01 Dec 2033

Prostate Cancer

What is this study about?

When a man is diagnosed with prostate cancer, doctors sometimes suggest something called 'active surveillance'. This means they carefully watch the cancer over time instead of starting treatment straight away. This is because many prostate cancers grow very slowly and may never cause problems. Active surveillance helps men avoid treatments that might have side effects if they're not really needed.

However, it can be tricky to know exactly when to stop watching and start treatment. There aren't clear, agreed-upon rules for when to do more tests like biopsies, or when to begin treatment. This often depends on a doctor's personal judgment. This study aims to find a better way. It compares this current, less structured approach with a new, more standardised plan that uses clear triggers – like changes in blood test results or how the prostate looks on an MRI scan – to decide if treatment is needed.

This study, PCASTT-UK, is really important because it's working alongside similar research happening in Scandinavia. By collecting information from many men in both the UK and other countries, researchers hope to figure out if having clear rules for when to act can reduce unnecessary treatments and their side effects, without increasing the risk of the cancer getting worse or being life-threatening. The goal is to provide the best possible care for men with prostate cancer.

Key takeaways

This study helps find the best way to manage prostate cancer that is being watched.
It aims to cut down on treatments that aren't needed, reducing side effects.
You'll be part of a group either following current care or a new structured plan.
Regular check-ups, blood tests, and scans will track your cancer for 10 years.
The study helps decide when it's truly time to start active treatment.
Your safety and wellbeing are the highest priority throughout the study.

Who may be eligible?

This study is looking for men who have been diagnosed with prostate cancer within the last year. Your cancer needs to be at an early stage, specifically described as T2a or less, and must not have spread to other parts of your body.

Your blood test results for PSA (Prostate-Specific Antigen) also need to be below a certain level. The type of cancer cells, called Gleason score, also needs to fit specific criteria, indicating it's likely a slower-growing type of cancer. Doctors will also check that you're in good health overall and are expected to live more than another 10 years, considering your age and other health conditions.

You would need to be well enough to have curative treatment (treatment aimed at curing the cancer) if it became necessary. You should also be able to understand and speak English to take part. The study is open to adult men of any age, as long as they meet the other health and cancer criteria.

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.

Have I been diagnosed with prostate cancer in the last year?
Is my prostate cancer at an early stage (T2a or less) and hasn't spread?
Are my PSA levels and cancer cell descriptions (Gleason score) within the study's range?
Do my doctors believe I'm healthy enough to live for more than 10 years?
Am I able to speak and understand English?
Would I be well enough for curative treatment if it became necessary?

Answer every question to see your result.

What does participation involve?

If you join this study, you will 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 continue with active surveillance as your doctor currently manages it. The other group will follow a new, more specific guideline for active surveillance.

Over the next 10 years, all participants will have regular check-ups. This includes a PSA blood test every six months, a general health check-up with your doctor each year (which also includes a PSA test), and you'll be asked to fill out a quality of life questionnaire once a year. You'll also have an MRI scan every two years. Depending on which group you're in, there will be different rules about when you might need repeat biopsies or when it might be time to start curative treatment. No matter which group you're in, the goal is to make sure your prostate cancer is monitored carefully.

Potential risks and benefits

Participating in this study might offer the benefit of receiving care that is part of the latest research, potentially leading to a better understanding of when to treat prostate cancer, avoiding unnecessary side effects. While the study aims to reduce overtreatment, there's always a slight risk that a standardised approach might miss something or delay necessary treatment, although great care is taken to monitor participants closely. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (5)

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

Bedford Hospital
Verified postcode
Bedford, United Kingdom
Epsom & St. Helier
Verified postcode
London, United Kingdom
Guy's Hospital
Verified postcode
London, United Kingdom
Queen Elizabeth Hospital
Verified postcode
London, United Kingdom
Royal Mardsen Hospital
Verified postcode
London, United Kingdom

Common questions

What is 'active surveillance'?

Active surveillance means closely watching your prostate cancer with regular tests instead of starting treatment immediately. It's for cancers that are likely to grow slowly.

Why is this study happening?

The study wants to find the best time to switch from watching prostate cancer to starting treatment, to avoid unnecessary treatments and their side effects, while still keeping you safe.

Will I receive treatment in this study?

The study doesn't involve starting treatment unless your cancer shows signs that it's getting worse, according to either your doctor's usual practice or the study's specific guidelines.

What's the difference between the two groups?

One group gets current standard care for active surveillance. The other group follows a new, specific set of rules for deciding when to do more tests or start treatment.

How long will I be in the study?

If you join, you will be followed up for 10 years to see how your cancer progresses and how effective each approach is.