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

NCT07225946

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Prostatic Neoplasms, Castration-Resistant

Interventions: Pasritamig, Docetaxel, Prednisone/Prednisolone

Countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (150)

Chandler, Arizona, United States
Little Rock, Arkansas, United States
Fountain Valley, California, United States
La Jolla, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Riverside, California, United States
San Diego, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
Edwards, Colorado, United States
Grand Junction, Colorado, United States
Lakewood, Colorado, United States
Sarasota, Florida, United States
Atlanta, Georgia, United States
Lisle, Illinois, United States
Wichita, Kansas, United States
Edgewood, Kentucky, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Towson, Maryland, United States
Sterling Heights, Michigan, United States
Saint Louis Park, Minnesota, United States
Saint Paul, Minnesota, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
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