A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (KLK2-PASenger)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Prostatic Neoplasms, Castration-Resistant

Treatments: Drug: Docetaxel; Drug: Pasritamig; Drug: Prednisone/Prednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT07225946

2025-522713-29-00 (Registry Identifier)

78278343PCR3003 (Other Identifier)

Details and patient eligibility

About

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 or death due to any cause) 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).

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have histologically confirmed adenocarcinoma of the prostate
• Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m^Tc bone scan 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 deciliter (ng/dL) (<= 1.73 nanomoles per Liter [nmol/L]) at screening
• Have progressed by PSA or CT/MRI or 99m^Tc bone scan on at least 1 novel androgen receptor pathway inhibition (ARPI) but 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)
• Received cytotoxic chemotherapy for prostate cancer in any setting
• Received prior treatment with human kallikrein 2 (KLK-2) directed therapies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Pasritamig+Docetaxel

Experimental group

Description:

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

Treatment:

Drug: Pasritamig

Drug: Docetaxel

Docetaxel

Active Comparator group

Description:

Participants will receive docetaxel along with prednisone/prednisolone as background medication.

Treatment:

Drug: Prednisone/Prednisolone

Drug: Docetaxel