Trial details
A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide with Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) following PSA Response in Participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: LIBERTAS
Official title: A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide with Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) following PSA Response in Participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Principal Investigator: Dr. Urban Emmenegger
Cancer type: Genitourinary
Cancer location: Genitourinary
Disease stage: Early Cancer
Trial phase: Phase 3
Intervention:
Registration #:
NCT05884398 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level < 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.
Inclusion Criteria: • Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate • Metastatic 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 metastasis • Have 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 therapy • A 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 treatment • Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce) • Assigned male at birth, inclusive of all gender identities • Participants who have undergone a bilateral orchidectomy and/or who are actively taking gender-affirming hormone therapy as part of their gender affirming care Exclusion Criteria: • History of seizure or known condition that has been determined to significantly predispose to seizure per investigator • Pelvic lymph nodes as only site of metastasis • Known allergies, hypersensitivity, or intolerance to excipients of apalutamide • Any 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 events • Gastrointestinal disorder affecting absorption
