Efficacy and Tolerability of Low-Dose Enzalutamide in Prostate Cancer

NCT06718647 | Not Yet Recruiting

• 1 other identifier: LODE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Enzalutamide; Low-Doses; Prostatic neoplasms; Elderly; Adverse event; Metastatic prostate cancer

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival

  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.

  1 year

• Adverse events

  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.

  At end of treatment with Enzalutamide

Secondary Outcomes (3)

• Overall Survival

  1 year

• Overall Survival

  3 years

• Prostate Specific Antigen response

  3 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of male patients aged 18 years or older with a histopathological diagnosis of metastatic prostate cancer who received Enzalutamide between 01/08/2014 and 31/12/2023.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monica Boitano: lead

Study Sites (1)

Ente Ospedaliero Ospedali Galliera

Genoa, GENOA, 16128, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrea De Censi

  Ente Ospedaliero Ospedali Galliera

  STUDY CHAIR

Central Study Contacts

Monica Boitano

CONTACT

00390105634505; monica.boitano@galliera.it

Martino Oliva

CONTACT

00390105634506; martino.oliva@galliera.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Coordinator

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)