Last updated 2 months ago
A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
663 patients around the world
Available in Puerto Rico, United States, Brazil
Janssen Research & Development, LLC
4Research sites
663Patients around the world
This study is for people with
Prostate cancer
Metastatic prostate cancer
Castration resistant prostate cancer
Requirements for the patient
From 18 Years
Male
Medical requirements
- Histologically confirmed adenocarcinoma of the prostate.Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs at the time of screening.PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL) at screening.In the opinion of the investigator, the next best treatment option is a clinical trial.Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access.Prior therapies could have been given in any disease setting (not limited to mCRPC).In particular, prior treatment specifications include receipt of the following:Androgen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI.Taxanes: Should have received at least 2 previous taxane-based regimens.If a participant has received only 1 taxane regimen, the participant is eligible if:Cabazitaxel is not available.The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance.Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period.Radioligand therapy: Should have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies:PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy.Polyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Should have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available.Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog [agonist or antagonist]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.Participants are eligible if they have the following values:eGFR >= 30 milliliters per minute (mL/min).Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (<=) 5 times the Upper Limit of Normal (ULN).Serum total bilirubin <= 3 * ULN.Absolute neutrophil count (ANC) >= 1.0 *10^9/per liter (L).Hemoglobin >= 8.0 grams per deciliter (g/dL).Platelet count >= 75 * 10^9/L.
- Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade <= 2) deep vein thrombosis is not exclusionary.Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus).Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation.Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s).Any of the following within 6 months prior to first dose of study treatment:Myocardial infarction.Severe or unstable angina.Clinically significant ventricular arrhythmias.Congestive heart failure (New York Heart Association class II to IV).Transient ischemic attack.Cerebrovascular accident.Prior treatment with any CD3-directed therapy.
Sites
CEPEN - CENTRO DE PESQUISA E ENSINO DE SANTA CATARINA
Recruiting
Associação Hospitalar Moinhos de Vento
Recruiting
Puerto Rico Medical Research Center
Recruiting
Pan American Center for Oncology Trials
Recruiting
StudyKLK2-comPAS
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Metastatic prostate cancerCastration resistant prostate cancer
Requirements
From 18 YearsMale
Unique study IDclinicaltrials.gov
NCT07164443
