Efficacy and Tolerability of Low-Dose Enzalutamide in Prostate Cancer
ConditionProstate Cancer Metastatic Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorMonica Boitano
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histological diagnosis metastatic prostate cancer;
Enzalutamide therapy taken between 01/08/2014 and 31/12/2023;
Age ≥ 18 years;
Signed Informed consent.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 3 trial groupsGroup A: Low Dose of Enzalutamide
Group B: Intermediate Dose of Enzalutamide
Group C: High Dose of Enzalutamide
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year2
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.
Time frame
At end of treatment with EnzalutamideSecondary outcomes
1
Overall Survival
To evaluate the Overall Survival, in terms of 1 year average survival time from the start of treatment, between low or intermediate doses compared to full dose;
Time frame
1 year2
Overall Survival
To evaluate the Overall Survival (OS), in terms of 3-years average survival time from the start of treatment, between low or intermediate doses compared to full dose;
Time frame
3 years3
Prostate Specific Antigen response
To evaluate the Prostate Specific Antigen response at 12 weeks between groups.
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Monica Boitano
Lead sponsor
Ente Ospedaliero Ospedali Galliera
Sponsor institution
Source ClinicalTrials.gov
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