RecruitingOBSERVATIONAL

Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)

This study, called PROceed, is looking at men with advanced prostate cancer that has spread and is no longer responding to standard hormone therapy. These men are being treated with a combination of two medicines, olaparib and abiraterone. Instead of a traditional clinical trial where treatment is controlled, this study observes how patients use these medicines in their everyday healthcare. Researchers want to understand how well the treatment works for different groups of patients and what their overall experience is like. They will also look at other treatments patients might have had before or after this combination. The aim is to gather real-world information to help doctors and patients make better decisions about care for this type of prostate cancer.

At a glance

Status

Recruiting

Sponsor

AstraZeneca

Enrolment target

250

Start

14 Feb 2024

Estimated completion

31 Jan 2027

Metastatic Castration-resistant Prostate Cancer

What is this study about?

This study is called PROceed, and it's looking at men who have a type of prostate cancer that has spread to other parts of the body (metastatic) and hasn't responded to earlier hormone treatments (castration-resistant). It focuses on patients who are being treated with a specific combination of two medicines: olaparib and abiraterone.

Unlike many traditional research studies, PROceed is an "observational" study. This means the researchers aren't telling doctors what treatments to give; instead, they are watching and recording how patients are treated in regular clinics and hospitals. They want to see how these medicines are used in everyday situations and how patients respond to them. They'll also note if patients had received certain other hormone treatments before starting olaparib and abiraterone, to see if that makes a difference.

The main goal is to understand the real-world experience of men on this treatment combination. This includes looking at things like their health improvements, how they feel, and what other treatments they may have had. The study will collect information over a few years, following patients from when they start olaparib until about a year after the last patient has joined. This kind of information is really valuable because it helps doctors and researchers understand how treatments work in a broader group of patients, rather than just the carefully selected people in a strict clinical trial.

Key takeaways

This study looks at men with advanced prostate cancer who are already receiving olaparib plus abiraterone.
It's an 'observational' study, meaning no new treatments or tests are given.
The goal is to understand how these medicines work in real-world everyday clinical practice.
Information collected will help improve care for future patients.
Your privacy will be protected, and participation is voluntary.

Who may be eligible?

To be part of this study, you need to be a man aged 18 or older. You must have a confirmed diagnosis of prostate cancer that has spread to other parts of your body (metastatic) and is no longer responding to standard hormone treatments.

It's also important that your prostate cancer has been properly identified as a certain type, called adenocarcinoma, usually confirmed by a tissue sample. You must have also started the specific combination treatment of olaparib and abiraterone around the time your local clinic or hospital joined the study.

You cannot join this study if you are already taking part in another clinical trial that is testing a new, unapproved prostate cancer medicine. This rule applies to treatments you might have received within 30 days before you started taking olaparib.

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 prostate cancer that has spread and is no longer responding to hormone therapy?
Is your prostate cancer specifically identified as adenocarcinoma?
Are you currently being treated with – or are about to start – the combination of olaparib and abiraterone?
Are you NOT currently in another clinical trial for a different, new prostate cancer drug?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be given any new treatments or asked to have extra tests that aren't already part of your usual care. It's an observational study, which means the researchers will simply collect information from your existing medical records about your treatment with olaparib and abiraterone.

They'll look at things like your health details, how the treatment is working for you, and any side effects you might experience, all as part of your routine care. The study aims to collect this information from when you begin olaparib and follow your progress for about one year after the last patient has started. The total study will enroll patients for up to two years, meaning information will be collected over an extended period.

Potential risks and benefits

Since this is an observational study, you won't be asked to do anything different from your usual medical care, so there are no additional risks from participating. The potential benefit is that the information gathered from your real-world experience, along with that of other patients, will help doctors better understand how this treatment works for men with your condition. This can lead to improved care for future patients. You have the right to withdraw your consent and stop participating in the study at any time without affecting your medical care.

Locations (34)

Research Site
Verified postcode
Aschaffenburg, Germany· Recruiting
Research Site
Verified postcode
Augsburg, Germany· Recruiting
Research Site
Verified postcode
Bergisch Gladbach, Germany· Recruiting
Research Site
Verified postcode
Berlin, Germany· Recruiting
Research Site
Verified postcode
Bonn, Germany· Recruiting
Research Site
Verified postcode
Cologne, Germany· Recruiting
Research Site
Verified postcode
Dresden, Germany· Recruiting
Research Site
Verified postcode
Duisburg, Germany· Recruiting
Research Site
Verified postcode
Eisenach, Germany· Recruiting
Research Site
Verified postcode
Eisleben Lutherstadt, Germany· Recruiting
Research Site
Verified postcode
Frankfurt, Germany· Recruiting
Research Site
Verified postcode
Greifswald, Germany· Recruiting

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This means your prostate cancer has spread to other parts of your body and is no longer being controlled by hormone therapies that reduce testosterone.

What are olaparib and abiraterone?

These are two different medicines used to treat prostate cancer. Olaparib targets certain genetic problems in cancer cells, and abiraterone is a hormone therapy.

Is this a clinical trial where I get new medicine?

No, this is an observational study. You would already be receiving olaparib and abiraterone as part of your standard care, and researchers would just gather information about your experience.

How long will I be involved in the study?

Researchers will collect information from your medical records from when you start olaparib until about one year after the last patient has joined the study.

Will my personal details be kept private?

Yes, all collected information will be handled carefully to protect your privacy and ensure your details are kept confidential.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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