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New cocktail of drugs shows promise for Hard-to-Treat prostate cancer

NCT ID NCT03431350

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This phase 2 trial is testing several drug combinations—including niraparib, cetrelimab, abiraterone acetate, and prednisone—in 136 men with metastatic castration-resistant prostate cancer (mCRPC), a form of the disease that has spread and stopped responding to standard hormone therapy. The study aims to find the safest and most effective doses and to measure how well the combinations shrink tumors or lower cancer markers. While the results could lead to better treatment options, the trial is still early and the side effects can be serious.

What this could mean

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

Active substance
niraparib, cetrelimab, abiraterone acetate, prednisone
What this could lead to
If successful, this could point toward new combination treatments that slow or shrink advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is a mid-stage trial with only 136 participants, so results may not apply to all patients. The drug combinations can cause serious side effects, and it is not yet known if they work better than existing options.

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

136 people

The number who actually took part.

Started

Mar 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

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 for Combination 3: * Diagnosed with mCRPC, who in the opinion of the investigator may benefit from treatment in Combination 3 of this study * Able to continue gonadotropin releasing hormone analogue (GnRHa) therapy during the study if not surgically castrate (that is, subjects who has not undergone bilateral orchiectomy). * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (\<=) 1 * Toxicity associated with prior chemotherapy or radiotherapy has resolved to Grade \<= 1 (except alopecia or Grade \<= 2 neuropathy) at screening * Participant must agree not to donate sperm while on study treatment, and for 3 months following the last dose of study treatment Exclusion Criteria: * History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) * Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: non-muscle invasive bladder cancer; skin cancer (non-melanoma or melanoma); breast cancer; malignancy that is considered cured with minimal risk of recurrence * Active infection requiring systemic therapy * Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients Combination 3: * Symptomatic brain metastases * Prior disease progression during combination treatment with AA and poly (adenosine diphosphate \[ADP\]-ribose) polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi-related toxicity

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

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

Prostatic neoplasms, castration-resistant

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Asaf Harofe Medical Center

    Beer Yaakov, 60930, Israel

  • Az Groeninge

    Kortrijk, 8500, Belgium

  • Azienda Ospedaliera ''Vito Fazzi''

    Lecce, 73100, Italy

  • Azienda Ospedaliera Universitaria Careggi di Firenze

    Florence, 50134, Italy

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z4E6, Canada

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, B-4000, Belgium

  • Centre de Recherche du CHUM

    Montreal, Quebec, H2X 0A9, Canada

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204, United States

  • First Urology, PSC

    Jeffersonville, Indiana, 47130, United States

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. Univ. de La Princesa

    Madrid, 28006, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025, Spain

  • Hospital Vall D'Hebron

    Barcelona, 8035, Spain

  • Houston Metro Urology

    Houston, Texas, 77027, United States

  • IRCCS-Fondazione Pascale

    Naples, 80131, Italy

  • MUSC-Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • Mayo Clinic - Division Of Hematology/oncology

    Jacksonville, Florida, 32224, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center 1

    Harrison, New York, 10604, United States

  • Michigan Institute of Urology

    Troy, Michigan, 48084, United States

  • New York Oncology Hematology

    Albany, New York, 12208, United States

  • OLV Ziekenhuis Aalst

    Aalst, 9300, Belgium

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G2M9, Canada

  • Rabin Medical Center

    Petah Tikva, 49100, Israel

  • Rambam Medical Center

    Haifa, 31096, Israel

  • Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

    Truro, TR1 3LJ, United Kingdom

  • Royal United Hospital

    Bath, BA1 3NG, United Kingdom

  • Sheba Medical Center Tel Hashomer

    Ramat Gan, 52621, Israel

  • Soroka Hospital

    Beersheba, 85101, Israel

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Southern Alberta Institute of Urology / Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9, Canada

  • The Royal Marsden NHS Trust Sutton

    Sutton, SM2 5PT, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • The Urology Center of Colorado

    Denver, Colorado, 80211, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • ULB Hôpital Erasme

    Brussels, 1070, Belgium

  • UOC Oncologia Ospedale Provinciale di Macerata

    Province of Macerata, 62100, Italy

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University College London Hospitals

    London, WC1E 6BT, United Kingdom

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 5379200, United States

  • Urological Associates of Southern Arizona, P.C.

    Tucson, Arizona, 85741, United States

  • Urology Associates

    Nashville, Tennessee, 37209, United States

  • Urology of Virginia, PLCC

    Virginia Beach, Virginia, 23462, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • ZNA Middelheim

    Antwerp, 2020, Belgium

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