Active not recruitingPHASE3INTERVENTIONAL

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

This study is looking into a new treatment for men with advanced prostate cancer that has spread and is no longer responding to standard hormone therapy. This type of cancer is called metastatic castration-resistant prostate cancer. The researchers want to see if combining a new drug called niraparib with the standard treatment (abiraterone and prednisone) is more effective than the standard treatment alone. The study aims to understand if this new combination can better control the cancer. Volunteers would be given either the new combination or the standard treatment, and their progress would be carefully monitored. The goal is to find better ways to manage this challenging form of prostate cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

765

Start

25 Jan 2019

Estimated completion

27 Feb 2027

Castration-Resistant Prostatic Cancer

What is this study about?

This study is about finding better ways to treat advanced prostate cancer. This is specifically for men whose prostate cancer has spread to other parts of the body (metastatic) and is no longer being controlled by standard hormone treatments (castration-resistant). At this stage, doctors are always looking for new and more effective therapies.

The main idea of this research is to test a new combination of medications. One of the drugs is called niraparib, and it's being given alongside a standard treatment which is a combination of abiraterone acetate and prednisone. Abiraterone and prednisone are already used to treat this type of prostate cancer. The study wants to see if adding niraparib to this existing treatment can improve how well it works compared to just having abiraterone and prednisone with a placebo (a dummy pill).

By comparing these two treatment approaches, researchers hope to learn if the new combination can help slow down the cancer's growth or improve the lives of men with this condition. The information gathered from this study could help doctors make better decisions about future treatments for advanced prostate cancer.

Key takeaways

This study evaluates a potential new combination treatment for advanced prostate cancer.
It targets metastatic castration-resistant prostate cancer.
Compares niraparib plus standard treatment against standard treatment alone.
Eligibility is based on specific genetic markers in the cancer and other health criteria.
Participation involves taking medication, regular check-ups, and scans.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To be part of this study, you would need to be a male with prostate cancer that has spread to other parts of your body, like your bones, and is no longer responding to hormone treatment. Your testosterone levels must be kept low, either by other medicines or by a past operation. You also need to have certain genetic changes in your cancer cells (called HRR gene alterations) which the researchers will check for.

There are also some reasons why you might not be able to join. For example, if you have already had certain types of treatment for advanced prostate cancer, including specific chemotherapy or other hormone-blocking drugs, or a type of medicine called a PARP inhibitor. Also, if you have other serious health conditions like certain blood disorders, or if your cancer has spread to your brain causing symptoms, you might not be suitable.

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 male with prostate cancer that has spread?
Has your prostate cancer stopped responding to hormone treatment, but your testosterone levels remain low?
Have you had specific genetic testing on your cancer?
Have you *not* had treatment with certain newer prostate cancer drugs or chemotherapy for your advanced cancer yet?
Do you have no active, spreading cancer in your brain?
Is your pain level generally mild, particularly your worst pain in the last 24 hours?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of two groups. One group will receive the new combination of niraparib, abiraterone, and prednisone. The other group will receive abiraterone, prednisone, and a dummy pill (placebo). Neither you nor your doctor will know which group you are in. You will take these medications regularly. Throughout the study, you will have regular visits to the clinic for check-ups, blood tests, and scans (like CT or MRI scans) to see how you are responding to the treatment. These tests will help the doctors monitor your cancer and your general health. You will also need to continue any hormone treatment you are already on. The total length of your participation would depend on how your cancer responds to the treatment.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could potentially work better than existing options for your prostate cancer, which is being carefully monitored by a medical team. However, there's no guarantee the new treatment will be more effective than the standard one. There could be side effects from the medications, some of which might be unpleasant or serious. The research team will carefully explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (318)

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

Urology Centers Of Alabama
Verified postcode
Homewood, United States
Mayo Clinic Arizona
Verified postcode
Phoenix, United States
Urological Associates of Southern Arizona, P.C.
Verified postcode
Tucson, United States
Arkansas Urology
Verified postcode
Little Rock, United States
Kaiser Permanente
Verified postcode
Riverside, United States
San Bernardino Urological Associates
Verified postcode
San Bernardino, United States
University of California San Francisco
Verified postcode
San Francisco, United States
Sansum Clinic Pharm
Verified postcode
Santa Barbara, United States
The Urology Center of Colorado
Verified postcode
Denver, United States
Colorado Clinical Research
Verified postcode
Lakewood, United States
VA Connecticut Healthcare
Verified postcode
West Haven, United States
Bay Pines VA Healthcare System
Verified postcode
Bay Pines, United States

Common questions

What is 'castration-resistant prostate cancer'?

This means your prostate cancer has continued to grow even though treatments have lowered your testosterone levels.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real medicine but contains no active drug. It helps researchers compare the true effect of a new medicine.

What are 'HRR gene alterations'?

These are specific changes in your genes that can sometimes make prostate cancer respond differently to certain treatments. The study will check your cancer for these changes.

Will I know which treatment I am getting?

No, this is a 'blinded' study, so neither you nor your doctor will know whether you are receiving the new combination or the standard treatment with a placebo.

How long will I be in the study?

The length of your participation can vary, as it depends on how your cancer responds to the treatment and your overall health.