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

Brief description of study

This is a Phase 3 study testing a new treatment for adult men with metastatic castration-resistant prostate cancer (mCRPC) who have already progressed after treatment with at least one ARPI. The main goal of this study is to see if a treatment combination of pasritamig (investigational drug) and docetaxel (chemotherapy drug) helps people with metastatic castration-resistant prostate cancer (mCRPC) live longer without the cancer getting worse compared to just using docetaxel. The second goal is to find out if the combination of pasritamig and docetaxel provides extra benefits, like having fewer problems due to the cancer, compared to just using docetaxel.

This is an open-label study, meaning both the researchers and participants know which treatment they are getting. In this study, participants will be randomly assigned in a 1:1 ratio to one of two arms: experimental arm or comparator arm. The randomization process will take into account different factors to ensure fairness. Some of these factors include: where the cancer has spread, LDH levels, ECOG performance status and previous use of PARP inhibitors.

In the experimental arm of the study, participants will receive a combination of pasritamig and docetaxel. In the comparator arm, participants will receive prednisone with docetaxel. In the comparator arm of the study, docetaxel will be used to see how the disease progresses and what changes happen to the participants without the active study drug pasritamig. This helps researchers understand what happens with just docetaxel treatment, without any extra effects from the new drug. All participants will continue to receive background androgen deprivation therapy (ADT) during treatment, or they must have previously had a bilateral orchiectomy (surgical removal of both testicles) with low testosterone levels (below 50 ng/dL).

All participants will have frequent medical check ups to see how their bodies are handling the study medicines. The study team will have special scans done for all participants to see how the cancer is responding to the study medicines. The study team will be monitoring the participants for potential side effects and safety concerns.


Clinical Study Identifier: s25-01742
ClinicalTrials.gov Identifier: NCT07225946
Principal Investigator: David R. Wise.
Other Investigators: Mary K O'Keeffe, Andrew Laccetti, Victor Ricardo Adorno Febles, Kenia J Rodriguez, Tiffany M Tomberlin, Laura Catherine Bauer, Doris M Salazar, Minas Platon Economides.


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