An observational study in Prostate Cancer Metastatic Disease, sponsored by Monica Boitano. Not yet recruiting at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Monica Boitano · Observational
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.
Prostate cancer is the most frequent cancer in males in the United States, with 299.000 new cases estimated in 2024, and it is the second leading cause of cancer-related death in men. Since 2014, the prostate cancer incidence rate has risen by 3% per year, mostly driven by 4-5% per year increases for regional-stage and distant-stage diagnoses that began as early as 2011. Localized-stage disease also increased from 73.5 per 100.000 in 2014 to 84.8 per 100.000 in 2019, although the trend is not yet statistically significant. A recent study estimated that more than one half of men in the United States living with metastatic prostate cancer were initially diagnosed with localized or regional stage disease. In Italy, there were more than 41.000 diagnosed cases in 2023 and 8.200 deaths, accounting for nearly one-fifth of all cancers detected in men, and over 560.000 prevalent cases of men living with prostate.
Enzalutamide is a new generation oral androgen-receptor selective inhibitor that induces tumor regression and growth suppression in patients with metastatic prostate cancer. It is effective and well tolerated, compared with other anticancer drugs (ex-chemotherapy), but in real practice, very often in patients with comorbidity or poor performance status is necessary reduce the dose to reduce fatigue or other adverse events.
The standard recommended dosage of 160 mg per day has multiple side effects and dose reductions are often required.
Several randomized studies have underscored the importance of enzalutamide in treating prostate cancer. Initially approved by the Food and Drug Administration in 2012 for patients with metastatic castration-resistant prostate cancer who had previously received docetaxel, its indications were updated in October 2020 to include patients with castration-resistant prostate cancer experiencing biochemical relapse, or with metastatic castration-sensitive prostate cancer.
In phase I study enzalutamide (MDV3100) was administered with dose between 30 and 600 mg per day. There was a linear increase in steady state serum concentration with dose, but antitumor effects were observed at all doses, including 40-60 mg per day. The severity of treatment related adverse effects including fatigue and neurological disorders was associated with drug dose.
Recent data suggest its efficacy may be retained at lower doses with significant improvement in safety and tolerability. In two previously observational studies, in metastatic prostate cancer low-dose enzalutamide (≤ 80 mg per day) compared to standard dose (160 mg per day) did not show difference in overall survival and prostate-specific antigen progression-free survival. Interestingly, there was a trend towards a better prostate-specific antigen response and a significantly longer life among the low-dose group.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Monica Boitano as lead sponsor.
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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.
Exclusion Criteria:
Low Dose of Enzalutamide: ≤ 50% of the standard dose
Intermediate Dose of Enzalutamide: \> 50% and ≤ 80% of the standard dose
High Dose of Enzalutamide: \> 80% of the standard dose
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 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.
Time frame: At end of treatment with Enzalutamide
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 year
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 years
Prostate Specific Antigen response
To evaluate the Prostate Specific Antigen response at 12 weeks between groups.
Time frame: 3 months
Plan to share: No
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