Metastatic Castration-Sensitive Prostate Cancer
Conditions
Interventions
None listed
Sponsors
The University of Osaka Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Age 20 or older Histologically confirmed prostate adenocarcinoma without neuroendocrine or small-cell differentiation Patients with metastatic castration-sensitive prostate cancer who were treated with enzalutamide Hormonal therapy (androgen deprivation therapy or combined androgen blockade) administered within 6 months before enrollment was permitted if the disease was clinically stable at the time of study entry Patients who had received neoadjuvant or adjuvant hormonal therapy for less than 36 months were eligible provided that a longer than 12-month washout period had elapsed before enrollment
Exclusion criteria
Exclusion criteria: Prior treatment with abiraterone, apalutamide, darolutamide, or docetaxel in the metastatic castration-sensitive setting Known allergy to enzalutamide Contraindications to hormonal therapy Absence of available formalin-fixed paraffin-embedded tumor specimens Insufficient DNA quality for genomic analysis Any condition deemed inappropriate for study participation by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the prevalence of somatic mutations in patients with metastatic castration-sensitive prostate cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints included the identification of genomic alterations associated with castration-resistant progression. | — |
Countries
Japan
Contacts
Public ContactKoji Hatano
The University of Osaka Graduate School of Medicine Urology
Outcome results
None listed