KLK2-PASenger for Metastatic Castration-resistant Prostate Cancer

What is the Purpose of this Study?

Participants will be placed into one of two groups by chance. One group will receive a new medicine called pasritamig together with a cancer medicine called docetaxel. The other group will receive docetaxel alone. Everyone will continue their usual hormone treatment unless both testicles have been surgically removed.

People who receive docetaxel alone will also take a steroid medicine called prednisone. People who receive pasritamig will not take prednisone because it may affect how the study medicine works. Both groups will receive medicines before treatment to help reduce side effects.

Researchers will compare the two treatment groups to learn if adding pasritamig can help treat prostate cancer better than standard treatment alone.

What is the Condition Being Studied?

People with progressive metastatic hormone resistant prostate cancer.

Who Can Participate in the Study?

People can join this study if they are adults with prostate cancer that has spread to other parts of the body and has continued to grow despite hormone treatment. The cancer must be a common type called adenocarcinoma and not certain rarer forms of prostate cancer. Participants must show signs that the cancer is getting worse based on blood tests or imaging scans.

They must continue hormone treatment or have had surgery to remove both testicles, with testosterone levels remaining very low. Participants must have previously received at least one newer hormone treatment for prostate cancer, such as abiraterone, apalutamide, enzalutamide, or darolutamide, and the cancer must have progressed despite that treatment. They cannot have received more than two of these hormone treatments. Researchers are studying whether adding a new medicine called pasritamig to standard treatment can better control advanced prostate cancer.

Age Group
Adults

What is Involved?

This study is testing whether adding a new medicine called pasritamig to a standard cancer treatment called docetaxel works better than docetaxel alone for people with advanced prostate cancer that has spread and no longer responds to hormone treatment. Researchers want to learn if the combination treatment can better control the cancer and help people live longer without their cancer getting worse. They will also study how safe the treatment is and what side effects it may cause.

Study Details

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 (KLK2-PASenger, 78278343PCR3003)
Principal Investigator
Assistant Professor of Medicine
Protocol Number
IRB: PRO00119439
NCT: NCT07225946
Phase
Phase III
ClinicalTrials.gov
Status
INSTITUTIONAL APPROVAL SIGNOFF