Active not recruitingNAINTERVENTIONAL

Prostate Testing for Cancer and Treatment

The 'Prostate Testing for Cancer and Treatment' (ProtecT) study is comparing different ways to manage early prostate cancer in men aged 50 to 69. When prostate cancer is found early, doctors sometimes suggest surgery to remove the prostate, radiation therapy to kill cancer cells, or 'active monitoring'. Active monitoring means keeping a close eye on the cancer and only starting treatment if it grows or causes problems. This study aims to find out which of these approaches leads to the best long-term results over 10 and 15 years. They will look at how well people survive, if the cancer comes back, any side effects from treatments, and how treatment affects daily life and wellbeing. It's an important study to help doctors and patients make better decisions about treating prostate cancer.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Oxford

Enrolment target

82,849

Start

01 Jun 2001

Estimated completion

31 Mar 2027

Prostate Cancer

What is this study about?

When prostate cancer is found early, meaning it hasn't spread outside the prostate gland, doctors have a few ways they might suggest managing it. These include surgery to remove the prostate gland (called a radical prostatectomy), radiation therapy which uses strong X-rays to target and kill cancer cells, or 'active monitoring'. Active monitoring means doctors regularly check your cancer with tests, but you don't start any immediate treatment. The idea is to only treat the cancer if it shows signs of growing or causing problems. Right now, we don't fully know which of these options is the most effective or has the best balance of benefits and side effects for men with early prostate cancer.

This study, called 'Prostate Testing for Cancer and Treatment' (ProtecT), aims to answer those questions. It's comparing these three different approaches – surgery, radiation therapy, and active monitoring – to understand which one works best over many years for men aged 50 to 69. The main goal is to see how these treatments affect survival after 10 and 15 years. But the study also looks at many other important things that impact a person's life.

For example, the researchers will investigate whether the cancer comes back, what side effects or problems people might experience from their treatment (like issues with peeing), and how having prostate cancer and its treatment affects someone's overall health, quality of life, and sex life. They will also look at the costs involved with finding and treating prostate cancer. By gathering all this information, the study hopes to provide clear answers to help future patients and their doctors make the most informed choices about early prostate cancer care.

Key takeaways

This study compares surgery, radiation, and active monitoring for early prostate cancer.
It aims to find the most effective long-term treatment for men aged 50-69.
Researchers will track survival, side effects, and quality of life for 10-15 years.
Participation helps future patients by improving prostate cancer care decisions.
You might be randomly assigned a treatment or, in some cases, choose one.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

The ProtecT study is looking for men aged between 50 and 69 years old. To take part, you need to have been diagnosed with prostate cancer that is still contained within the prostate (localized prostate cancer).

It's important that you are fit enough to have surgery or radiation therapy, should you be offered those options, and that doctors expect you to live for at least another 10 years. You also need to be registered with a local GP surgery that is part of the study.

You cannot join the study if you are unable to understand and agree to take part in writing, or if you have had other types of cancer in the past or currently. The study is specifically designed for men within the age range and with prostate cancer that hasn't spread.

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.

I am a man between 50 and 69 years old.
I have been diagnosed with localized prostate cancer (cancer that hasn't spread).
My doctors believe I am fit enough for surgery or radiation, if needed.
I am expected to live for at least another 10 years.
I am able to understand and sign consent forms.
I have not had other types of cancer in the past or currently.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might be offered surgery, radiation therapy, or active monitoring. The treatment group you are in will be decided by chance (like flipping a coin), or you might be able to choose which approach you prefer, and your progress will be followed very carefully.

Taking part would involve regular check-ups with your doctors. These check-ups will help the study team monitor your prostate cancer, look for any side effects from treatment, and see how your general health and wellbeing are. You would have appointments over a long period, typically for 10 to 15 years, to track your health and the cancer's progress. This follow-up might include blood tests, questionnaires about your health and quality of life, and possibly other scans or tests as needed. The exact number of visits will depend on your treatment group and what your doctors recommend, but it's a long-term commitment to help researchers understand better how these treatments work over many years.

Potential risks and benefits

Participating in this study might offer you some benefits, as you'll receive close monitoring and care for your prostate cancer under the guidance of specialists. You would also be contributing vital information that could help many other men with prostate cancer in the future. However, there are potential risks, as with any medical treatment or research study. These risks vary depending on the treatment you receive; for example, surgery has risks like bleeding or infection, radiation might cause fatigue or bowel changes, and active monitoring carries the risk that the cancer might grow before treatment starts. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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

Queen Elizabeth Hospital
Verified postcode
Birmingham, United Kingdom
Southmead Hospital
Verified postcode
Bristol, United Kingdom
Addenbrokes' Hospital
Verified postcode
Cambridge, United Kingdom
University Hospital of Wales
Verified postcode
Cardiff, United Kingdom
Western General Hospital
Verified postcode
Edinburgh, United Kingdom
Leicester General Hospital
Verified postcode
Leicester, United Kingdom
Freeman Hospital
Verified postcode
Newcastle, United Kingdom
Royal Hallamshire Hospital
Verified postcode
Sheffield, United Kingdom

Common questions

What is 'active monitoring' for prostate cancer?

Active monitoring means your doctors watch your prostate cancer very closely with regular tests, but you don't start any immediate treatment unless there are signs it's growing or causing problems.

What kind of treatments are being compared?

The study is comparing surgery to remove the prostate, radiation therapy (using X-rays to kill cancer cells), and active monitoring (watching the cancer closely).

How long will I need to be involved in the study?

The study follows participants for a long time, typically 10 to 15 years, to see the long-term effects of the different treatments.

Why is this study important?

It's important because it aims to find out which treatment for early prostate cancer works best over many years, helping doctors and patients make better decisions in the future.

Can I choose my treatment if I join?

In some cases, you might be able to choose your treatment. In others, it might be decided by chance to ensure fair comparison between all options.