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A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT ID: NCT07225946

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2030-06-20

Brief Summary

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The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).

Detailed Description

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Conditions

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Prostatic Neoplasms, Castration-Resistant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pasritamig+Docetaxel

Participants will receive pasritamig along with docetaxel until the end of trial (EOT) visit or until confirmed radiographic progression by blinded independent central review (BICR), or any other protocol defined criteria are met.

Group Type EXPERIMENTAL

Pasritamig

Intervention Type DRUG

Pasritamig will be administered.

Docetaxel

Intervention Type DRUG

Docetaxel will be administered.

Docetaxel

Participants will receive docetaxel along with prednisone as background medication.

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

Docetaxel will be administered.

Prednisone

Intervention Type DRUG

Prednisone will be administered.

Interventions

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Pasritamig

Pasritamig will be administered.

Intervention Type DRUG

Docetaxel

Docetaxel will be administered.

Intervention Type DRUG

Prednisone

Prednisone will be administered.

Intervention Type DRUG

Other Intervention Names

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JNJ-78278343

Eligibility Criteria

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Inclusion Criteria

* Have histologically confirmed adenocarcinoma of the prostate
* Have disease that is metastatic at the time of the screening as determined by the investigator
* Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (\<=) 50 nanogram per milliliter (ng/dL) (\<= 1.73 nanomoles per Liter \[nmol/L\]) at screening
* Have progressed on at least 1 novel androgen receptor pathway inhibition (ARPI) but received no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion Criteria

* Known history of either brain or leptomeningeal prostate cancer metastases
* Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated
* Prior or concurrent second malignancy (other than the disease under study) because the natural history or treatment could interfere with study endpoints
* Received cytotoxic chemotherapy for prostate cancer in any setting
* Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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78278343PCR3003

Identifier Type: OTHER

Identifier Source: secondary_id

2025-522713-29-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

78278343PCR3003

Identifier Type: -

Identifier Source: org_study_id