Last updated 15 days ago
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
420 patients around the world
Available in Brazil, United States
Janssen Research & Development, LLC
1Research sites
420Patients around the world
This study is for people with
Prostate cancer
Castration sensitive prostate cancer
Metastatic prostate cancer
Requirements for the patient
From 18 Years
Male
Medical requirements
- Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostateMetastatic prostate cancer disease documented by conventional imaging (example, computed tomography [CT], magnetic resonance imaging [MRI], or bone scan) and/or next-generation imaging [NGI] demonstrating greater than equal (>=) 2 distinct extraprostatic sites of metastasisHave an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapyA participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatmentMust be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)Assigned male at birth, inclusive of all gender identitiesParticipants who have undergone a bilateral orchidectomy and/or who are actively taking gender-affirming hormone therapy as part of their gender affirming care
- History of seizure or known condition that has been determined to significantly predispose to seizure per investigatorPelvic lymph nodes as only site of metastasisKnown allergies, hypersensitivity, or intolerance to excipients of apalutamideAny of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic eventsGastrointestinal disorder affecting absorption
Sites
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
Recruiting
StudyLIBERTAS
SponsorJanssen Research & Development, LLC
Conditions
Castration sensitive prostate cancerMetastatic prostate cancer
Requirements
From 18 YearsMale
Unique study IDclinicaltrials.gov
NCT05884398
