Efficacy and Tolerability of Low-Dose Enzalutamide in Prostate Cancer

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.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

* Patients with histological diagnosis metastatic prostate cancer;
* Enzalutamide therapy taken between 01/08/2014 and 31/12/2023;
* Age ≥ 18 years;
* Signed Informed consent.

Exclusion Criteria:

* Clinically significant cardiovascular disease for example cerebrovascular accidents (\<=6 months), myocardial infarction (\<=3 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF); uncontrolled hypertension or bradycardia
* Patients who died within one month of starting treatment with Enzalutamide for all causes;
* Uncontrolled concomitant diseases.