Active not recruitingPHASE2INTERVENTIONAL

A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

This study is investigating different combinations of new drugs for men with advanced prostate cancer that has spread and is no longer controlled by hormone treatment (called metastatic castration-resistant prostate cancer, or mCRPC). Researchers are particularly interested in a drug called niraparib, given with other anti-cancer medicines like cetrelimab or abiraterone. The main goals are to find the safest and most effective doses of these combinations, understand how well they fight the cancer, and see how the body absorbs and uses the drugs. This is an important step in finding new treatments for a type of prostate cancer that can be very challenging to treat.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

136

Start

02 Mar 2018

Estimated completion

31 Dec 2026

Prostatic Neoplasms, Castration-Resistant

Results

Results from this study

Posted November 2023

Results have been published for this study.

Primary outcome

Combination 1: Part 1: Number of Participants With Specified Toxicity

Number of participants with specified toxicity during Cycle 1 was reported. Only toxicities that occurred during safety evaluation period(defined as first 28 days of treatment-Cycle 1 of Part 1) was used for analysis of specified toxicities and for dose reduction decisions. Toxicities were graded for severity as per NCI-CTCAE, version 4.03. Safety evaluation criteria were: Any Grade(G) \>=3 non-hematological toxicity without anorexia, or constipation, fatigue improved to G\<=2 in \<7 days, vomiting and diarrhea resolved in \<=3 days, laboratory abnormalities with hospitalization, tumor flare improved to G\<=2 in \<=7 days, elevation in AST/ALT for \<=7 days and G3 hypertension controlled by medical therapy; any treatment-related(TR)G4 or G\>=3 thrombocytopenia required platelet transfusion; Any TR G4 neutropenia \>=7 days or G3 or 4 neutropenia with infection/fever \>38.5 degrees Celsius; Any TR SAE or intolerable toxicity.

Full results on the registry

What is this study about?

This study is for men who have prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to standard hormone treatments. This specific type of cancer is called 'castration-resistant' because even though hormone levels are kept very low, the cancer continues to grow.

The study aims to explore new ways to treat this advanced prostate cancer by using combinations of different drugs. One key drug being looked at is niraparib. In some parts of the study, it will be combined with another drug called cetrelimab. In other parts, niraparib will be combined with abiraterone acetate and prednisone, which are drugs already used for prostate cancer. The researchers want to find the best and safest doses of these new combinations and see how effective they are at shrinking or controlling the cancer.

They also want to understand how the body uses and processes these drugs when given together. This is important to ensure the drugs work well and safely. By doing this research, doctors hope to discover better treatment options for men whose prostate cancer has become difficult to manage with existing therapies.

Key takeaways

It's for advanced prostate cancer that has stopped responding to hormone therapy.
The study explores new drug combinations, including niraparib.
Main goals are finding safe doses and seeing how well the combinations work.
Participation involves regular check-ups and monitoring.
You can leave the study at any time.

Who may be eligible?

This study is specifically looking for men with prostate cancer that has spread and is no longer responding to hormone therapy. You would need to be well enough to take part, able to continue any current hormone treatments if you're not surgically castrated, and have mostly recovered from any side effects of previous treatments.

There are also certain conditions that would prevent you from joining. For instance, if you have a history of certain blood disorders, other active cancers (unless they are very minor or cured), or serious active infections, you would not be able to participate. You also can't join if you've had severe allergic reactions to any of the study drugs or related medicines.

If your cancer has spread to your brain and is causing symptoms, or if you've previously developed resistance to a similar combination of drugs, you would also not be eligible for one particular part of the study.

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.

Have you been diagnosed with prostate cancer that has spread and is no longer controlled by hormone treatment?
Are you generally well and active enough for daily tasks?
Have you mostly recovered from any side effects of previous cancer treatments (apart from mild hair loss or nerve issues)?
Are you willing not to donate sperm during and for 3 months after the study treatment?
Do you have any other serious active cancers, infections, or specific blood disorders?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey would typically involve several stages. First, there's a pre-screening and screening phase where doctors will check if the study is right for you through various tests and reviews. If you are eligible, you will enter the 'Treatment Phase' where you will receive the study drugs as prescribed. This involves regular visits for tests, scans, and discussions with the study team to monitor how you're doing, how the drugs are affecting your cancer, and if you're experiencing any side effects. After the treatment phase, there will be a 'Follow-up Phase' where the team continues to check on your health. Some participants might also enter a 'Long-term Extension' phase for continued monitoring. For one specific part of the study (Combination 3), the main focus is on how your body handles the drugs, so you would have particular assessments for that, followed by an extension phase.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might gain access to new treatments that aren't widely available yet, which could help your cancer. However, the study treatments might not work for you, or they could cause side effects, some of which might be serious. The research team will carefully explain all known risks. Your safety is the priority, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (50)

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

Urological Associates of Southern Arizona, P.C.
Verified postcode
Tucson, United States
The Urology Center of Colorado
Verified postcode
Denver, United States
Mayo Clinic - Division Of Hematology/oncology
Verified postcode
Jacksonville, United States
First Urology, PSC
Verified postcode
Jeffersonville, United States
Chesapeake Urology Research Associates
Verified postcode
Towson, United States
Michigan Institute of Urology
Verified postcode
Troy, United States
New York Oncology Hematology
Verified postcode
Albany, United States
Memorial Sloan Kettering Cancer Center 1
Verified postcode
Harrison, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
Thomas Jefferson University
Verified postcode
Philadelphia, United States
University of Pittsburgh Medical Center (UPMC)
Verified postcode
Pittsburgh, United States
MUSC-Hollings Cancer Center
Verified postcode
Charleston, United States

Common questions

What kind of cancer is this study for?

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

Why are doctors combining these drugs?

Doctors are combining drugs to see if they can be more effective together at fighting the cancer than when used alone.

What are the main goals of this study?

The main goals are to find the safest and most effective doses of these new drug combinations and to understand how well they work against the cancer.

Will I receive a new drug or a standard treatment?

You will receive combinations of drugs, some of which are new study drugs, and others which may be standard treatments for prostate cancer.

How long would I be in the study?

The total time in the study can vary, involving treatment, follow-up, and potentially a long-term monitoring phase.