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Prostate cancer drug combo gets a formulation check

NCT ID NCT04577833

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study looks at how the body absorbs different versions of two prostate cancer drugs, niraparib and abiraterone acetate, taken together with prednisone. It involves 136 men with metastatic castration-resistant prostate cancer. The goal is to compare the absorption of various tablet strengths and forms, not to test if the drugs work against the cancer.

What this could mean

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

Active substance
niraparib and abiraterone acetate (with prednisone)
What this could lead to
If successful, this study could help identify the best formulation of these drugs for future use, potentially improving treatment convenience or effectiveness for men with prostate cancer.
What could go wrong
This is an early Phase 1 trial focused on drug absorption, not on curing or controlling the cancer itself. The results may not lead to any direct benefit for participants or change current 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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

136 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Dec 2027

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: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Diagnosed with metastatic castration-resistant prostate cancer (mCRPC), who in the opinion of the investigator may benefit from treatment in this study * Able to continue gonadotropin-releasing hormone analogues (GnRHa) therapy during the study if not surgically castrate (that is, participants who have not undergone bilateral orchiectomy) * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (\<=) 1 * Willing to provide a tumor sample (archival) for determination of homologous recombination repair (HRR) gene alteration status Exclusion Criteria: * Symptomatic brain metastases * Prior disease progression during treatment with abiraterone acetate (AA) alone or when combined with a poly adenosine diphosphate (ADP)-ribose polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi related toxicity. * History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) * Known allergies, hypersensitivity, or intolerance to niraparib or AA or the corresponding excipients of niraparib/AA * Any medical condition that would make prednisone/prednisolone use contraindicated

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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

  • ARENSIA Exploratory Medicine Unit

    Kyiv, 01135, Ukraine

  • Arensia Exploratory Medicine

    Chisinau, Md2025, Moldova

  • Arensia Exploratory Medicine 1

    Tbilisi, 0112, Georgia

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • GZA Ziekenhuizen- Campus St Augustinus

    Wilrijk, 2610, Belgium

  • HIA Begin

    Saint-Mandé, 94163, France

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Institut Bergonié, Centre de Lutte Contre le Cancer

    Bordeaux, 33000, France

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76, Sweden

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • START Mountain Region

    West Valley City, Utah, 84119, United States

  • Sir Bobby Robson Unit, Northern Centre for Cancer Care

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

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