Prostate cancer treatment has long prioritized survival over quality of life, leaving patients with metastatic hormone-sensitive prostate cancer (mHSPC) to endure debilitating side effects from lifelong therapies like androgen deprivation therapy (ADT). The LIBERTAS clinical trial is challenging this paradigm by testing whether de-escalating treatment in responsive patients could strike a better balance between efficacy and well-being.

LIBERTAS (Phase III) focuses on patients who achieve undetectable PSA levels (<0.2 ng/mL) after six months of ADT combined with apalutamide, an androgen receptor inhibitor. These patients are then randomized into two groups:

Standard care: Continued ADT + apalutamide.

De-escalation: Apalutamide alone + intermittent ADT.

The goal? To determine if reducing ADT use—while maintaining apalutamide—preserves survival benefits while alleviating side effects like hot flashes, fatigue, and sexual dysfunction.

Clinicians often pause or adjust ADT informally for toxicity, but no robust data supports this practice. LIBERTAS aims to provide the first high-quality evidence for personalized treatment in mHSPC.
ADT side effects can significantly impair daily life. By prioritizing hot flash reduction as a co-primary endpoint, the trial acknowledges that survival is not the only metric of success.

The trial’s 71% undetectable PSA rate after six months—far exceeding historical benchmarks—highlights apalutamide’s potency and validates PSA as a tool for tailoring therapy.

But we still need to wait for the results on the efficacy of intermittent ADT in this population.

Source.