MedTrace Logo

Efficacy and Tolerability of Low-Dose Enzalutamide in Prostate Cancer

NCT06718647 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-07-16

No results posted yet for this 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.

Conditions

  • Prostate Cancer Metastatic Disease

Sponsors & Collaborators

  • Monica Boitano

    lead OTHER

Principal Investigators

  • Andrea De Censi · Ente Ospedaliero Ospedali Galliera

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06718647 on ClinicalTrials.gov