Efficacy and Tolerability of Low-Dose Enzalutamide in Prostate Cancer

Condition(s) studied

Study summary

Prostate cancer is the most common cancer in men in the United States and the second leading cause of cancer-related mortality in males. Since 2014, its incidence has increased by 3% annually, primarily due to a rise in advanced-stage cases. In Italy, over 41.000 cases were diagnosed in 2023, with 8.200 deaths. Enzalutamide, an androgen receptor inhibitor, is effective in treating metastatic prostate cancer but often requires dose reductions to improve tolerability in frail patients. Recent studies have shown that lower doses (≤ 80 mg per day) can maintain efficacy while improving safety and tolerability, with outcomes comparable to the standard dose (160 mg per day) in terms of overall survival, progression-free survival, and prostate-specific antigen response.

Based on the results observed in these studies, the investigators expect that in our retrospective cohort of patients with metastatic prostate cancer, those who received low doses of enzalutamide will have a 1 year progression-free survival comparable to the full dose. The investigators will also expect a lower rate of adverse events.

Eligibility

Primary outcome measure(s)

• Progression Free Survival — 1 year
  The primary objective of this retrospective observational study is to evaluate whether low or intermediate doses of enzalutamide are comparable to the full dose in terms of 1-year average progression free survival time from the start of treatment, considering the event as the pathological progression of the disease.
• Adverse events — At end of treatment with Enzalutamide
  To evaluate the rate of adverse events worsening between low, intermediate and full dose groups. As adverse events, fatigue, hypertension and neurological disorders will be assessed as adverse events of special interest.

Trial sites (1)