Metastatic hormone-resistant prostate cancer is prostate cancer that has spread to other parts of the body and continues to grow despite treatments that keep testosterone levels very low. Although treatment options are available, many men eventually need additional therapies. Researchers continue to study new approaches that may help slow disease progression, improve quality of life, and provide additional treatment options.
Official 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 Hormone-Resistant Prostate Cancer.
Pasritamig in the Phase 3 KLK2-PASenger Clinical Study
The KLK2-PASenger study is evaluating the investigational treatment pasritamig (JNJ-78278343) in combination with docetaxel for men with metastatic hormone-resistant prostate cancer that has progressed after at least one androgen receptor pathway inhibitor (ARPI) treatment. The main goal of the study is to learn whether pasritamig plus docetaxel may help delay cancer growth or spread compared with docetaxel alone. Researchers will also continue to study overall survival, safety, side effects, symptoms, and quality of life.
Pasritamig is an investigational bispecific antibody. One part attaches to a protein called KLK2, which is found on some prostate cancer cells. The other part attaches to T cells, which help the immune system fight disease. By bringing these cells together, pasritamig may help the immune system find and attack prostate cancer cells.
Docetaxel is a chemotherapy medicine that is already used to treat advanced prostate cancer. Researchers are studying whether combining pasritamig with docetaxel may provide additional benefit compared with docetaxel alone.
Study Design
This is a Phase 3, randomized, open-label clinical study. Approximately 800 participants are expected to enroll worldwide. Participants will be assigned by chance to one of two study groups:
- One group will receive pasritamig plus docetaxel
- One group will receive docetaxel alone
Because this is an open-label study, participants and study doctors will know which treatment is being given.
Who Can Participate?
Men may qualify if they:
- Are 18 years of age or older
- Have metastatic hormone-resistant prostate cancer
- Have previously received at least one androgen receptor pathway inhibitor (ARPI)
- Have cancer that has continued to grow despite prior treatment
- Meet all study eligibility requirements
The study team will review medical history, prior treatments, blood tests, scans, and other criteria to determine eligibility.
What Participation May Involve
Participation includes screening, study treatment, and follow-up. Study treatment may include IV infusions of pasritamig and docetaxel, blood tests, physical examinations, imaging scans, and questionnaires about symptoms and quality of life. Participants will be monitored throughout the study, and follow-up may continue after treatment ends so researchers can learn more about long-term outcomes and survival.
Possible Benefits and Risks
Possible benefits may include slowing cancer growth or delaying the spread of cancer. Because pasritamig is investigational, it may or may not benefit participants.
Possible side effects of docetaxel may include:
- Low blood cell counts
- Fatigue
- Infection
- Nausea
- Hair loss
- Numbness or tingling in the hands or feet
Possible side effects of pasritamig may include:
- Infusion-related reactions
- Fever
- Fatigue
- Cytokine release syndrome (CRS)
- Changes in blood test results
- Neurologic side effects
Participants are monitored closely throughout the study.
Organization:
Janssen Research & Development, LLC.
https://klk2-pasenger.clinicaltrials.jnj.com/
ClinicalTrials.gov Information:
- NCT Number: NCT07225946
- Title: A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (KLK2-PASenger)
Use the “clinical trials glossary” and “dictionary” for words, phrases, and treatments that you may not understand.
Register your interest or comments about this trial with PHEN
Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.
GLOSSARY OF TERMS
Click any word to see what it means.
Bispecific antibody
A medicine designed to attach to two different targets at the same time.
Clinical trial
A research study involving people that tests a medicine, treatment, or medical approach.
Cytokine release syndrome
A reaction that can happen when the immune system becomes very active.
Hormone therapy
Treatment that lowers or blocks hormones that can help prostate cancer grow.
Infusion-related reaction
A reaction that happens during or shortly after an IV infusion.
Investigational medicine
A medicine that is still being studied for the use described in the clinical trial.
IV infusion
A way to give medicine through a needle or small tube placed in a vein.
KLK2
A protein found on some prostate cancer cells.
Metastatic hormone-resistant prostate cancer
Prostate cancer that has spread and continues to grow even when hormone treatment keeps testosterone very low.
Open-label
Both you and your study doctor know which study treatment is being given.
Placebo
A treatment that looks like the study medicine but has no active medicine.
Premedication
Medicine given before study treatment to help prevent or reduce side effects.
Quality of Life
A person’s overall well-being, including physical, emotional, and daily life experiences.
Random assignment
Placement into a study group by chance, usually by a computer.
Randomized
You are assigned to a treatment group by chance, not by you or your doctor.
Step-up dosing
Starting with a lower dose and slowly increasing the amount.
Supportive care
Care that helps control symptoms, improve comfort, and support quality of life.
T cell
A white blood cell that helps the immune system respond to disease.
Treatment cycle
A set period during which study treatment and tests take place.
