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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Pasritamig
DrugPasritamig will be administered.
Docetaxel
DrugDocetaxel will be administered.
Prednisone/Prednisolone
DrugPrednisone/Prednisolone will be administered.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
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 to Subsequent Therapy (TST)
TST is defined as time from randomization to the initiation of any subsequent systemic anticancer therapy for prostate cancer
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.
Sponsors and contacts
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