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New drug shows promise for tough prostate cancer

NCT ID NCT02854436

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called niraparib in 289 men with advanced prostate cancer that no longer responds to hormone therapy and has specific DNA repair issues. The goal was to see if the drug could shrink tumors or slow the disease. Results may help identify which patients could benefit from this targeted approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
niraparib
What this could lead to
If successful, this could point toward a new targeted treatment option for men with this type of advanced prostate cancer.
What could go wrong
This is a phase 2 trial, so results are still early. The drug may not work for everyone and could cause side effects. More research is needed before it becomes a standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

289 people

The number who actually took part.

Started

Aug 2016

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is excluded) * Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer with evidence of disease progression on or after treatment, or discontinued from a taxane-based chemotherapy due to an adverse event * Received a second-generation or later androgen receptor (AR)-targeted therapy (for example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the treatment of metastatic prostate cancer with evidence of disease progression or non-metastatic castration-resistant prostate cancer with evidence of subsequent metastasis * Biomarker-positive by at least one of the following criteria: (a) Biallelic deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing) * Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry Exclusion Criteria: * Prior treatment with a poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor * Prior platinum-based chemotherapy for the treatment of prostate cancer * Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) * Symptomatic or impending cord compression * Symptomatic brain metastases

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostatic neoplasms

Contacts and locations

Locations

  • Study site

    Tucson, Arizona, United States

  • Study site

    Los Angeles, California, United States

  • Study site

    Riverside, California, United States

  • Study site

    Sacramento, California, United States

  • Study site

    Aurora, Colorado, United States

  • Study site

    Denver, Colorado, United States

  • Study site

    Evanston, Illinois, United States

  • Study site

    Danville, Kentucky, United States

  • Study site

    Louisville, Kentucky, United States

  • Study site

    New Orleans, Louisiana, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    Detroit, Michigan, United States

  • Study site

    Omaha, Nebraska, United States

  • Study site

    New York, New York, United States

  • Study site

    Durham, North Carolina, United States

  • Study site

    Lancaster, Pennsylvania, United States

  • Study site

    Philadelphia, Pennsylvania, United States

  • Study site

    Myrtle Beach, South Carolina, United States

  • Study site

    Houston, Texas, United States

  • Study site

    Charlottesville, Virginia, United States

  • Study site

    Fairfax, Virginia, United States

  • Study site

    Seattle, Washington, United States

  • Study site

    Madison, Wisconsin, United States

  • Study site

    Camperdown, Australia

  • Study site

    Darlinghurst, Australia

  • Study site

    East Albury, Australia

  • Study site

    Kurralta Park, Australia

  • Study site

    Macquarie University, Australia

  • Study site

    Melbourne, Australia

  • Study site

    Murdoch, Australia

  • Study site

    Port Macquarie, Australia

  • Study site

    Randwick, Australia

  • Study site

    Wahroonga, Australia

  • Study site

    Aalst, Belgium

  • Study site

    Brussels, Belgium

  • Study site

    Charleroi, Belgium

  • Study site

    Ghent, Belgium

  • Study site

    Haine-Saint-Paul, Belgium

  • Study site

    Hasselt, Belgium

  • Study site

    Kortrijk, Belgium

  • Study site

    Liège, Belgium

  • Study site

    Namur, Belgium

  • Study site

    Ottignies, Belgium

  • Study site

    Wilrijk, Belgium

  • Study site

    Barretos, Brazil

  • Study site

    Belo Horizonte, Brazil

  • Study site

    Curitiba, Brazil

  • Study site

    Fortaleza, Brazil

  • Study site

    Ijuí, Brazil

  • Study site

    Itajaí, Brazil

  • Study site

    Joinville, Brazil

  • Study site

    Natal, Brazil

  • Study site

    Salvador, Brazil

  • Study site

    São Paulo, Brazil

  • Study site

    Vancouver, British Columbia, Canada

  • Study site

    Oshawa, Ontario, Canada

  • Study site

    Toronto, Ontario, Canada

  • Study site

    Montreal, Quebec, Canada

  • Study site

    Québec, Quebec, Canada

  • Study site

    Aarhus N, Denmark

  • Study site

    Copenhagen N, Denmark

  • Study site

    Herlev, Denmark

  • Study site

    Odense C, Denmark

  • Study site

    Avignon, France

  • Study site

    Besançon, France

  • Study site

    Caen, France

  • Study site

    Lyon, France

  • Study site

    Nice, France

  • Study site

    Paris, France

  • Study site

    Reims, France

  • Study site

    Strasbourg, France

  • Study site

    Villejuif, France

  • Study site

    Beersheba, Israel

  • Study site

    Haifa, Israel

  • Study site

    Kfar Saba, Israel

  • Study site

    Ramat Gan, Israel

  • Study site

    Zrifin, Israel

  • Study site

    Alkmaar, Netherlands

  • Study site

    Amsterdam, Netherlands

  • Study site

    Groningen, Netherlands

  • Study site

    Maastricht, Netherlands

  • Study site

    Rotterdam, Netherlands

  • Study site

    Moscow, Russia

  • Study site

    Omsk, Russia

  • Study site

    Tomsk, Russia

  • Study site

    Seoul, South Korea

  • Study site

    Barcelona, Spain

  • Study site

    Córdoba, Spain

  • Study site

    Madrid, Spain

  • Study site

    Málaga, Spain

  • Study site

    Pozuelo de Alarcón, Spain

  • Study site

    Santander, Spain

  • Study site

    Santiago de Compostela, Spain

  • Study site

    Seville, Spain

  • Study site

    Valencia, Spain

  • Study site

    Gothenburg, Sweden

  • Study site

    Lund, Sweden

  • Study site

    Stockholm, Sweden

  • Study site

    Umeå, Sweden

  • Study site

    Kaohsiung City, Taiwan

  • Study site

    Taichung, Taiwan

  • Study site

    Tainan, Taiwan

  • Study site

    Taipei, Taiwan

  • Study site

    Taoyuan County, Taiwan

  • Study site

    Blackburn, United Kingdom

  • Study site

    Bristol, United Kingdom

  • Study site

    Cardiff, United Kingdom

  • Study site

    Exeter, United Kingdom

  • Study site

    London, United Kingdom

  • Study site

    Preston, United Kingdom

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