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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pasritamig

    Drug

    Pasritamig will be administered.

  • Docetaxel

    Drug

    Docetaxel will be administered.

  • Prednisone/Prednisolone

    Drug

    Prednisone/Prednisolone will be administered.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Pasritamig+DocetaxelExperimental treatment 2 interventions
Group B: DocetaxelActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Radiographic Progression-Free Survival (rPFS) by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan Assessed by Blinded Independent Central Review (BICR)

rPFS by CT/MRI or bone scan is assessed by BICR and is defined as the time from the date of randomization to the first date of radiographic disease progression, or death due to any cause, whichever occurs first.

Time frame
Up to approximately 1 years 10 months

Secondary outcomes

1

Overall Survival (OS)

OS is defined as the time from the date of randomization to the date of death due to any cause.

Time frame
Up to approximately 4 years 5 months
2

Time to Symptomatic Progression (TSP)

TSP is defined as the time from the date of randomization to the date of the first occurrence of any of the following: the use of external beam radiation to relieve cancer-related symptoms, the need for tumor-related surgical intervention, other cancer-related procedures, cancer-related morbid events, and initiation of a new systemic anticancer therapy because of cancer symptoms.

Time frame
Up to approximately 4 years 5 months
3

Time to Subsequent Therapy (TST)

TST is defined as time from randomization to the initiation of any subsequent systemic anticancer therapy for prostate cancer

Time frame
Up to approximately 4 years 5 months
4

Time to Skeletal-Related Event (TSRE)

TSRE is defined as the time from the date of randomization to the date of first occurrence of any of the following (whichever occurs first): the use of external beam radiation therapy to relieve skeletal symptoms, the need for tumor-related orthopedic surgical intervention, the occurrence of new bone fractures (cancer-related; vertebral or non-vertebral) or the occurrence of tumor-related spinal cord compression.

Time frame
Up to approximately 4 years 5 months

Other outcomes

Sponsors and contacts

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