Tests pasritamig with docetaxel against docetaxel alone in advanced prostate cancer
Tests pasritamig plus docetaxel in men with spreading prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Key facts
- Where
- Kota Kinabalu, Kuala Lumpur, and Kuching, MalaysiaSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with prostate cancer that has spread and keeps growing despite hormone-lowering treatment. It tests pasritamig with docetaxel against docetaxel alone.
- Age
- 18 years or older
- Sex
- All sexes listed by the registry; the cancer studied is prostate cancer.
- Disease stage
- Prostate adenocarcinoma confirmed under the microscope, spread to other parts of the body (metastatic) on CT or MRI and a bone scan. Ongoing hormone-lowering treatment (or earlier surgery to remove both testicles) with testosterone at or below 50 ng/dL. Daily activity level (ECOG) of 0 to 1.
- Earlier treatment
- The cancer must have progressed on at least 1 but no more than 2 different androgen receptor pathway inhibitors, which must be stopped before joining. No earlier chemotherapy for prostate cancer and no earlier treatment aimed at KLK-2.
- Biomarker or test result
- Participants with known BRCA 1/2 gene changes must have already had a PARP inhibitor, unless it was not available or not safe for them.
Main reasons for not taking part
- Known cancer spread to the brain or the membranes around it
- Known BRCA 1/2 change without earlier PARP inhibitor treatment, unless not available or not safe
- Another cancer, past or current, besides the prostate cancer
- Earlier chemotherapy for prostate cancer in any setting
- Earlier treatment directed at human kallikrein 2 (KLK-2)
Read by machine on 9 November 2026.
Where in Malaysia
- Hospital Wanita Dan Kanak-Kanak SabahKota Kinabalu, MalaysiaTaking people
- Hospital Kuala LumpurKuala Lumpur, MalaysiaTaking people
- Pantai Hospital Kuala LumpurKuala Lumpur, MalaysiaTaking people
- University Malaya Medical CentreKuala Lumpur, MalaysiaTaking people
- Hospital Umum SarawakKuching, MalaysiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07225946EU 2025-522713-29-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer
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).
Inclusion: 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: 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; Known history of either brain or leptomeningeal prostate cancer metastases.