Pasritamig With Docetaxel vs Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Research type
Research Study
Full title
A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer
IRAS ID
1012816
Contact name
Peter Chatfield
Contact email
Sponsor organisation
Janssen-Cilag International NV
ISRCTN Number
ISRCTN12271587
Research summary
Metastatic castrate-resistant prostate cancer (mCRPC) is a cancer that forms in tissues of male reproductive gland found below the bladder (prostate) and keeps growing despite low levels of male hormones. Although treatment options are available, mCRPC cannot be cured and still causes serious health problems and can lead to death. Pasritamig (JNJ-78278343) is a bispecific antibody* that targets human kallikrein 2 protein on tumour cells and cluster of differentiation 3 protein on T-cells (key cell of immune system). This activates T-cells, which damage tumour cells and stop them from growing.
*protein that recognizes and attaches to 2 different targets.
Docetaxel is a standard of care (widely accepted) treatment option for advanced prostate cancer**.
**cancer that has spread to other parts of body.
In this study, researchers want to assess whether combination treatment of pasritamig and docetaxel prolongs radiographic Progression-Free Survival (rPFS) when compared to treatment with docetaxel alone.
The study consists of:
1.Screening phase (up to 28 days)
2.Treatment phase (up to last dose of study treatment): Participants will be randomly (by chance) assigned to either of the following arms:
a. Pasritamig and Docetaxel
b. Docetaxel
3.End of trial (EOT) visit (within 42 days of last dose of study drug or start of next anticancer therapy)
4.Follow-up phase:
a. Post-treatment follow-up (every 6 weeks): For participants whose disease has not worsened after the treatment or who have not started any next anticancer therapy.
b. Survival follow-up (every 12 weeks until death, loss to follow-up, or study withdrawal, whichever occurs first): For participants whose disease has worsened after the treatment.Safety assessments include physical examinations, vital signs, adverse events and laboratory assessments. The overall duration of the study is around 3 years 5 months.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0374
Date of REC Opinion
7 Jan 2026
REC opinion
Further Information Favourable Opinion