(UroToday.com) The 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA was host to a prostate cancer trials in progress poster session. Dr. Arun Azad presented the study design for LIBERTAS, a phase 3 randomized controlled trial of apalutamide plus intermittent versus continuous androgen deprivation therapy (ADT) in participants with metastatic castration-sensitive prostate cancer (mCSPC).
Apalutamide is an androgen receptor pathway inhibitor (ARPI) approved for the treatment of mCSPC and non-metastatic castration-resistant prostate cancer patients, based on results of the TITAN and SPARTAN trials, respectively.1,2 In the phase 3 TITAN study of participants with mCSPC treated with the combination of apalutamide + ADT, a ‘deep’ PSA response (≥90% decline from baseline, undetectable PSA <0.2 ng/mL, or both) achieved at three, six, and 12 months following apalutamide initiation was associated with improved clinical outcomes, including overall survival (OS) and radiographic progression-free survival (rPFS).
However, ADT is associated with adverse events and worse quality of life (QoL) in individuals with advanced prostate cancer. To date, treatment recommendations for the use of intermittent ADT as an ADT-sparing approach remain limited.
LIBERTAS is the first phase III trial evaluating apalutamide + intermittent versus continuous ADT in individuals with mCSPC. Notably, LIBERTAS is the first de-gendered and transgender-inclusive prostate cancer study, serving as a foundational guide for future clinical study protocols. Broad eligibility criteria are used to achieve greater inclusiveness of underserved and under-represented populations and allow for increased diversity in race, ethnicity, gender identity, and physical disability of study participants.
LIBERTAS is an international, open-label, randomized study enrolling participants with mCSPC, inclusive of all gender identities. Approximately 333 participants are planned for enrollment at 86 sites across nine countries, over two years. The key inclusion and exclusion criteria are summarized below:
The objective of the study is to evaluate whether apalutamide + intermittent ADT in participants with mCSPC who achieved PSA <0.2 ng/mL after 6 months of initial therapy with apalutamide + ADT provides non-inferior rPFS and reduces hot flash burden compared with apalutamide + continuous ADT.
Subjective patient-reported outcomes (PROs) will be complemented with objective data from digital health tools (ActiGraph watch and CANTAB® neurocognitive assessments) to better characterize QoL in the intermittent and continuous ADT arms. An independent data monitoring committee will conduct an interim analysis of futility for the primary endpoint and periodic review of safety data
The study start date was August 31, 2023. The projected total study time is 5.6 years (22 months for accrual + 45 months for treatment).
Presented by: Arun Azad, PhD, MBBS, FRACP, Associate Professor, Department of Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, San Francisco, CA, January 25th – January 27th, 2024
Related content: LIBERTAS Trial Tests Less Treatment, Better Quality of Life in Responding mHSPC Patients - Arun Azad
References:
- Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med 2019 Jul 4;381(1):13-24.
- Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med 2018;378(15):1408-1418.