RecruitingNAINTERVENTIONAL

The PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance

This study, called 'PRECISION', is exploring a new way to treat early prostate cancer. Currently, some patients receive radiotherapy over 5 sessions. This study is testing if just 3 daily sessions can be just as effective with similar or even fewer side effects. It uses a clever tracking device, similar to a GPS, called RayPilot HypoCath. This device helps the medical team pinpoint the exact location of the prostate during treatment. If the prostate moves even a tiny bit, the system alerts them, ensuring the radiotherapy hits only the cancer and protects nearby organs like the bladder and bowel. The goal is to make treatment more convenient for patients, reduce travel, and potentially ease the burden on hospitals, while maintaining high safety and effectiveness for men with early prostate cancer.

At a glance

Status

Recruiting

Phase

Sponsor

NHS Lothian

Enrolment target

100

Start

01 Nov 2024

Estimated completion

01 Nov 2027

Localized Prostate Cancer Low Risk Prostate Cancer Intermediate Risk Prostate Cancer

What is this study about?

Prostate cancer is the most common cancer in men in the UK. Thankfully, if caught early, treatment can often cure it. Two main treatments are surgery or radiotherapy. While both are effective, they can sometimes cause changes to a man's sexual health, and how his bladder and bowels work, which can affect his quality of life.

Over the years, radiotherapy has come a long way. Thanks to more advanced machines, the number of treatment sessions needed has greatly reduced – from 39 down to 5. This has made a big difference for patients, meaning less time spent at the hospital, less travel, and fewer days off work. Even with these improvements, there's always a focus on making treatments even better, hoping to reduce both immediate and long-term side effects even further.

This study takes the next step, aiming to cut down the number of radiotherapy sessions even further, to just 3. These three sessions would be given on consecutive days. The study uses a special tool called RayPilot HypoCath. Think of it like a GPS for the prostate. It continuously tracks the prostate's exact position during radiotherapy. If the prostate moves more than a tiny amount (about 2mm), treatment is paused until it's back in the right spot. This incredible accuracy means the radiotherapy goes exactly where it's needed, targeting the cancer while trying to protect other important organs nearby, like the bladder and bowel. By improving this accuracy, the hope is to make treatment even safer, reduce side effects, and make it much more convenient for patients.

Key takeaways

Treats early prostate cancer with just 3 daily radiotherapy sessions.
Uses a 'GPS-like' system (RayPilot) for extreme precision during treatment.
Aims to reduce hospital visits and improve patient convenience.
Hopes to have similar or fewer side effects compared to current 5-session treatments.
Focuses on men with low or intermediate risk early prostate cancer.

Who may be eligible?

This study is open to men with certain types of early prostate cancer. Generally, this means your cancer hasn't spread and is considered to be of 'low' or 'intermediate' risk. You'll need to have a prostate of a certain size, and your bladder function will be checked to make sure it's working well, for example, how fast you can pee and if you fully empty your bladder.

There are also some reasons why you might not be able to join. For example, if you've had certain surgeries like a TURP or a hip replacement, or if you've had radiotherapy to your pelvic area before. Other health conditions, like certain bowel problems, or another active cancer (apart from some skin cancers), would also mean you can't take part. Your doctor will carefully check all these details to see if this study is right for you.

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.

Do you have early-stage prostate cancer that your doctor considers low or intermediate risk?
Have you *not* had previous radiotherapy to your pelvis?
Do you *not* have certain medical conditions like inflammatory bowel disease or another active cancer (excluding some skin cancers)?
Have you *not* had surgeries like a TURP or hip replacement?
Are you able to provide consent and follow the study instructions?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive radiotherapy for your prostate cancer in just three sessions, usually on consecutive days. Before starting, and during the treatment, a special device called a RayPilot HypoCath will be used. This is a modified urinary catheter that sits in the bladder, with the tracking part placed where it passes through your prostate to help guide the radiotherapy. You will have regular appointments and checks to monitor your progress and any side effects. The total duration of your participation, including follow-up, will be discussed by the study team, but typically involves reviews over a longer period to track long-term effects.

Potential risks and benefits

Potential benefits of taking part include receiving a very quick and precise radiotherapy treatment in just three sessions, which means less time at the hospital and less disruption to your daily life. The advanced tracking system aims to reduce potential side effects on your bladder and bowel. However, as with any medical treatment, there are potential risks, and some side effects may still occur, though the study aims for them to be similar to or less than existing treatments. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

NHS Lothian
Verified postcode
Edinburgh, United Kingdom· Recruiting

Common questions

What is SBRT?

SBRT stands for Stereotactic Body Radiotherapy. It's a very precise type of radiotherapy that delivers high doses of radiation to a small area, like the prostate, over fewer sessions.

What is the RayPilot system?

The RayPilot system is a device, similar to a GPS, that continuously tracks the exact position of your prostate during radiotherapy. This helps ensure the treatment is incredibly accurate.

Why only 3 sessions?

The aim is to find out if reducing the number of radiotherapy sessions from 5 to 3 can be just as effective, with similar or fewer side effects, making treatment more convenient and less demanding for patients.

Will this treatment hurt?

Radiotherapy itself is painless, similar to having an X-ray. The RayPilot system involves a modified catheter, which the team will explain in detail, but treatments are designed to be as comfortable as possible.

Is this a new, unproven treatment?

While giving radiotherapy in 3 sessions for prostate cancer is being studied, SBRT is an established treatment. The unique aspect here is combining it with the highly accurate RayPilot system to see if 3 sessions can become a new standard.

How to find out more

Richard Allan

richard.allan@nhslothian.scot.nhs.uk +44 1315371463 Official trial record

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