PASenger: Phase 3 Randomized study of Pasritamig with Docetaxel, versus Docetaxel for Metastatic Prostate Cancer
Principal Investigator:
Study sponsor: Janssen Research & Development, LLC.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of the study is to compare Pasritamig + Docetaxel in combination vs Docetaxel alone, to see if it will prolong progression-free survival time. The study drug Pasritamig works by attaching itself to a specific protein that is expressed in cancer cells, with T-Cells (part of your immune system), and brings them closer together. This helps the body’s immune system to target and kill the cancer cells.
Inclusion Criteria:
– Must be at least 18 years old.
– Must have confirmed adenocarcinoma of the prostate.
– Must have metastatic disease at time of screening.
– Must have progressed on at least 1 ARPI, but received no more than 2 different ARPI (abiraterone acetate, enzalutamide, darolutamide, apalutamide) for any disease stage.
– Must have ECOG of 0 – 1.
– Must have adequate organ function, as determined by local lab tests.
– Must agree to contraceptive methods and not to donate sperm or eggs while on study or for 6 months after the last dose.
*Additional criteria may apply, and will be discussed with the physician and research team.
Exclusion Criteria:
– Known history of brain or leptomeningeal prostate cancer metastases.
– Patients with known BRCA 1/2 mutations who have not received treatment with a PARP inhibitor.
– Has not recovered from a recent surgery, or has had a prior solid organ or bone marrow transplant.
– Has active autoimmune disease within 12 months that requires steroids.
– Has Cardiovascular dysfunction within 6 months prior to first dose (to be discussed with treating physician).
– Has a prior or current second malignancy (to be discussed with treating physician).
– Has received chemo for prostate cancer (Docetaxel, cabazitaxel, mitoxantrone), or other treatments that target KLK-2. Additional prior treatments that are exclusionary should be discussed with the treating physician.
– HIV positive patients are excluded, unless specific criteria are met.
– Patients with active hepatitis are excluded.
– Has received a live vaccine within 4 weeks prior to first dose.
– Received glucocorticoids (dose of >10mg/day of prednisone or similar) within 3 days prior to first dose.
– Received radiation therapy within 14 days prior to first dose.
– Any other condition which, in the opinion of the physician, would interfere or limit protocol specified assessments.
*Additional exclusion criteria may apply and will be discussed with the physician and research team.
Study Contact:
Alissa Gavenda
(952) 993-6705
alissa.gavenda@parknicollet.com
