AuthorisedTherapeutic confirmatory (Phase III)Interventional

PSMA PET For intermediate- or high-risk prostate cancer prior to RadioTherapY: A prospective interventional randomized clinical trial (P4RTY)

This study is for men in the UK with prostate cancer that is considered intermediate or high risk. Before they have their radiotherapy treatment, some men will have a special type of scan called a PSMA PET scan using a substance called Locametz, while others will receive standard care. Researchers want to see if having this advanced scan helps doctors make better decisions about treatment and if it improves how long men live without their cancer getting worse. They will follow participants closely to see if the scan helps prevent the cancer from coming back or spreading, and they'll also check for any side effects.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitaetsklinikum Essen AöR

Enrolment target

352

Start

04 Jul 2025

Prostate cancer

What is this study about?

This study, called P4RTY, is for men with prostate cancer where the risk of it spreading or returning is considered medium to high. You might hear this called 'intermediate- or high-risk prostate cancer'. The main idea behind this study is to explore if a special type of scan, called a PSMA PET scan, can help doctors plan the best treatment before you start radiotherapy.

Currently, doctors use different scans and tests to understand your cancer. A PSMA PET scan is a newer, very detailed imaging test that can show where prostate cancer cells are in the body, even very small ones. For this study, some participants will have this PSMA PET scan using a specific substance called Locametz, while others will have their treatment planned using the usual scans and tests. The aim is to compare these two approaches.

The researchers will follow everyone in the study to see if the group who had the PSMA PET scan before radiotherapy does better in the long run. They'll be looking at things like whether the cancer comes back, spreads, or if there are any serious side effects. Ultimately, this study aims to find out if using this advanced scan can lead to more effective treatment plans and better outcomes for men with prostate cancer.

Key takeaways

This study explores a new scan (PSMA PET) for prostate cancer.
It's for men with intermediate- or high-risk prostate cancer before radiotherapy.
Researchers want to see if the scan improves treatment planning and outcomes.
Participation involves monitoring your health and cancer over time.
You can stop participating at any point.

Who may be eligible?

This study is for adult men, aged 18 and over, who have been diagnosed with prostate cancer that is considered intermediate or high risk. This means your doctors believe your cancer has a higher chance of coming back or spreading compared to low-risk cancer.

You would need to be suitable for radiotherapy as a treatment for your prostate cancer. Other specific medical details will be checked by the study team to ensure the study is safe and appropriate 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.

Are you a man aged 18 or older?
Do you have intermediate- or high-risk prostate cancer?
Are you planning to have radiotherapy for your prostate cancer?
Are you generally well enough to participate in a study?

Answer every question to see your result.

What does participation involve?

If you join this study, you might be asked to have a PSMA PET scan using Locametz before your radiotherapy, or you might follow the usual care path. You will receive radiotherapy as planned. The study team will closely monitor your health and your cancer's progress. This will involve regular check-ups, blood tests (including PSA tests), and various scans to see how your treatment is working. These appointments will continue for several years after your radiotherapy, to track the long-term effects of your treatment. The study will also carefully record any side effects you experience.

Potential risks and benefits

Potential benefits of taking part could include gaining a more detailed understanding of your cancer through advanced imaging, which might help your doctors tailor your treatment. However, there's no guarantee the PSMA PET scan will directly improve your outcome in this study. Potential risks include those associated with scans, such as exposure to a small amount of radiation from the PSMA PET scan, and potential side effects from the Locametz substance, although these are usually mild. As with any medical study, there's also the chance of unknown side effects. Your safety and well-being are a priority, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is prostate cancer?

Prostate cancer is a common cancer that affects the prostate, a small gland in men that is part of the reproductive system.

What is radiotherapy?

Radiotherapy is a cancer treatment that uses high-energy rays to destroy cancer cells, often by aiming them directly at the tumour.

What is a PSMA PET scan?

It's a special imaging scan that helps doctors find prostate cancer cells in the body, even tiny ones, by using a mild radioactive substance that attaches to these cells.

Is Locametz a medicine?

Locametz is a substance used with the PSMA PET scan to help highlight prostate cancer cells, it is not a treatment for the cancer itself.

What does 'intermediate- or high-risk' mean?

It means your prostate cancer has certain features that suggest it has a higher chance of growing more quickly or spreading than very low-risk cancers.