Compares low and standard doses of enzalutamide in men with advanced prostate cancer
Compares a lower enzalutamide dose with the standard dose in adults with metastatic prostate cancer.
Key facts
- Who runs it
- Monica Boitano
- Where
- Genoa, ItalySee the site
- Trial code
- Registry title
- Efficacy and Tolerability of Low-Dose Enzalutamide in Prostate Cancer
- Status
- Not yet recruiting
- People taking part
- 150 people, planned
- Started
- 1 Sept 2025
- Planned end
- 31 Dec 2025
- Type of study
- Observational, 3 groups
- Record updated
- 16 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with metastatic prostate cancer who took enzalutamide between 01/08/2014 and 31/12/2023. Past records are reviewed.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Metastatic prostate cancer confirmed by tissue examination (histological diagnosis)
- Earlier treatment
- Must have taken enzalutamide between 01/08/2014 and 31/12/2023
Main reasons for not taking part
- Clinically significant heart or blood vessel disease, such as stroke (≤6 months), heart attack (≤3 months), unstable angina, NYHA grade II or greater heart failure, uncontrolled high blood pressure or slow heart rate
- Died from any cause within one month of starting enzalutamide
- Other uncontrolled illnesses
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Patients with histological diagnosis metastatic prostate cancer
- Enzalutamide therapy taken between 01/08/2014 and 31/12/2023
- Age ≥ 18 years
- Signed Informed consent
Who cannot take part
- Patients who died within one month of starting treatment with Enzalutamide for all causes
- Uncontrolled concomitant diseases
- 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
Where in Italy
- Ente Ospedaliero Ospedali GallieraGenoa, ItalyContact: Martino OlivaNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- Low Dose of Enzalutamide
Low Dose of Enzalutamide: ≤ 50% of the standard dose
- Intermediate Dose of Enzalutamide
Intermediate Dose of Enzalutamide: \> 50% and ≤ 80% of the standard dose
- High Dose of Enzalutamide
High Dose of Enzalutamide: \> 80% of the standard dose
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy and Tolerability of Low-Dose Versus Standard-Dose Enzalutamide in Advance Prostate Cancer: a Real-World Evidence Study
- Plain-language title
- Compares low and standard doses of enzalutamide in men with advanced prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 16 July 2025