Active not recruitingPHASE1INTERVENTIONAL

A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

This study is looking into different versions of two medicines, niraparib and abiraterone acetate, used to treat prostate cancer that has spread and didn't respond to previous hormone treatment. The main goal is to understand how these medicines are absorbed and used by the body. This helps doctors ensure patients get the right amount of medicine. Participants will take these medicines along with prednisone. The study will also explore whether genetic changes in a patient's cancer cells affect how well the treatments work. This research is important for improving future prostate cancer treatments and making sure they are as effective and safe as possible for patients.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Janssen Research & Development, LLC

Enrolment target

136

Start

13 Nov 2020

Estimated completion

31 Dec 2026

Prostatic Neoplasms

What is this study about?

This study is for men with a type of prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone treatments. This is called metastatic castration-resistant prostate cancer, or mCRPC. The study focuses on two specific medications: niraparib and abiraterone acetate (AA). You might know these medicines are already used for prostate cancer, but researchers are looking at different ways to deliver them, perhaps as new formulations or strengths.

The main aim is to understand how these different forms of the medicines are absorbed into your body and how they work. This is important because it helps scientists find the best and most effective way to give these drugs. You would also take prednisone, which is often given with abiraterone acetate. The study will also be looking at whether certain genetic changes in prostate cancer cells affect how well these treatments work. About 15% to 20% of prostate cancers have these genetic changes.

By comparing different versions of these medicines, researchers hope to improve existing treatments. This could mean more effective ways to manage advanced prostate cancer for patients in the future, potentially leading to better outcomes or fewer side effects. It's a way to fine-tune existing therapies to make them work even better.

Key takeaways

Tests new forms of existing prostate cancer drugs.
Aims to improve how medicines are absorbed by the body.
For advanced prostate cancer that has spread.
Involves regular medical check-ups and monitoring.
Could last up to 1 year and 5 months.
Participation is voluntary, you can leave any time.

Who may be eligible?

To join this study, you would need to be a man diagnosed with prostate cancer that has spread and is no longer held in check by standard hormone treatments (mCRPC). Your doctor would need to think that this study might be a good fit for you.

You would also need to be well enough to carry out most daily activities, and if you haven't had surgery to remove your testicles, you'd need to continue your hormone treatment throughout the study. The research team would also ask for a sample of your cancer tissue to check for specific genetic changes.

There are some reasons why you couldn't join. For example, if your cancer has spread to your brain and is causing symptoms, or if your prostate cancer has previously gotten worse while you were taking abiraterone acetate or a similar drug called a PARPi. You also couldn't join if you have certain blood disorders, severe allergies to the study drugs, or any health conditions that would make taking prednisone unsafe 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 with prostate cancer that has spread and is advanced?
Has your prostate cancer become resistant to standard hormone treatments?
Are you able to manage most regular daily activities?
Are you willing to provide a past cancer tissue sample?
Do you have a history of certain blood disorders like MDS or AML?

Answer every question to see your result.

What does participation involve?

If you join this study, it will be split into several parts and could last for up to 1 year and 5 months. First, there will be a screening period of up to 3 weeks to make sure you're suitable for the study. After that, the main treatment phase will last for about 3 weeks, where you'll take the study medications.

Following the treatment phase, there will be an 'extension' phase. During this time, you'll continue receiving treatment and having regular check-ups until your doctor decides the treatment is no longer working for you, or you decide to stop. Throughout the study, you'll have various tests and visits. These will include blood tests to measure how the drugs are working in your body, and assessments to check how safe the treatments are for you and if they are having any effect on your cancer.

After you stop taking the study medication, there will be one final follow-up visit about a month later to check on your health. The study team will carefully monitor your health and any side effects you might experience during your participation.

Potential risks and benefits

Participating in a clinical study means you could potentially benefit from new treatments before they are widely available. While this study uses existing medications, it aims to find better ways to use them, which might offer a new approach to managing your prostate cancer. However, there's no guarantee the treatment will work for you or be better than standard care. Like all medicines, the study drugs can have side effects, which the medical team will monitor closely. You will be told about all known possible risks before you decide to join. Remember, taking part is completely voluntary, and you have the right to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (16)

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

START Mountain Region
Verified postcode
West Valley City, United States
Universitair Ziekenhuis Gent
Verified postcode
Ghent, Belgium
GZA Ziekenhuizen- Campus St Augustinus
Verified postcode
Wilrijk, Belgium
Institut Bergonié, Centre de Lutte Contre le Cancer
Verified postcode
Bordeaux, France
HIA Begin
Verified postcode
Saint-Mandé, France
Arensia Exploratory Medicine 1
Verified postcode
Tbilisi, Georgia
Arensia Exploratory Medicine
Verified postcode
Chisinau, Moldova
Erasmus MC
Verified postcode
Rotterdam, Netherlands
Uniwersyteckie Centrum Kliniczne
Verified postcode
Gdansk, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Verified postcode
Warsaw, Poland
Hosp Univ Fund Jimenez Diaz
Verified postcode
Madrid, Spain
Hosp Univ Hm Sanchinarro
Verified postcode
Madrid, Spain

Common questions

What kind of cancer is this study for?

This study is for men with prostate cancer that has spread and is no longer responding to initial hormone treatments.

What medicines are being studied?

The study is looking at different ways of giving niraparib and abiraterone acetate, along with prednisone.

Why are researchers doing this study?

They want to find the best way for your body to absorb and use these medicines, to make treatments more effective.

How long will the study last?

The total study time, including follow-up, could be up to about 1 year and 5 months.

Will I get free treatment if I join?

The study will cover the costs of the study treatments and related assessments, but you should discuss specific details with the study team.