NCT06718647Not yet recruiting
Efficacy and Tolerability of Low-Dose Enzalutamide in Prostate Cancer
Efficacy and Tolerability of Low-Dose Versus Standard-Dose Enzalutamide in Advance Prostate Cancer: a Real-World Evidence Study
Source: ClinicalTrials.gov · Last updated 16 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 2 Dec 2024
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Monica Boitano
- Diseases
- Prostate cancer
- NCT number
- NCT06718647
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Sept 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who died within one month of starting treatment with Enzalutamide for all causes;
- Uncontrolled concomitant diseases.
Other illness
- 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
Who the study is looking for
- Patients with histological diagnosis metastatic prostate cancer;
- Enzalutamide therapy taken between 01/08/2014 and 31/12/2023;
- Age ≥ 18 years;
- Signed Informed consent.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ente Ospedaliero Ospedali Galliera Coordinator of this site? Confirm its status | Genoa | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.