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

Sponsored by Janssen Research & Development, LLC

About this trial

Last updated 22 days ago

Study ID

78278343PCR3003

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 months ago

What is this trial 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) 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).

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting
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Recruiting
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Recruiting
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Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
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Recruiting
Recruiting
Recruiting
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Recruiting
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Recruiting
Recruiting

For more information, view the full study details:

NCT07225946