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Taking people in MalaysiaPhase 3

Tests pasritamig with docetaxel against docetaxel alone in advanced prostate cancer

Tests pasritamig plus docetaxel in men with spreading prostate cancer.

Key facts

Who runs it
Janssen Research & Development, LLC
Where
Kota Kinabalu, Kuala Lumpur, and Kuching, MalaysiaSee the 5 sitesAlso in 16 other countries, 160 sites
Registry title
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Status
Recruiting
Phase
Phase 3
People taking part
800 people, planned
Started
19 Dec 2025
Expected to end
7 Jun 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Pasritamig
  • Docetaxel
  • Prednisone/Prednisolone
Record updated
3 November 2026

Who can take part

AI summary

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)

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Malaysia

Also in 16 other countries, 160 sites

  • 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

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Pasritamig+DocetaxelTreatment being tested

    Participants will receive pasritamig along with docetaxel until the end of treatment (EOT) visit or until radiographic disease progression is confirmed by blinded independent central review (BICR), or any other protocol defined criteria are met.

    Treatment: Pasritamig and Docetaxel

  • DocetaxelExisting treatment, for comparison

    Participants will receive docetaxel along with prednisone/prednisolone as background medication.

    Treatment: Docetaxel and Prednisone/Prednisolone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests pasritamig with docetaxel against docetaxel alone in advanced prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026