Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061776) titled 'A Prospective Multicenter Study of Exploring Genomic Correlates of Clinical Outcome in Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving Enzalutamide' on June 3.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka Graduate School of Medicine

Condition: Condition - Metastatic Castration-Sensitive Prostate Cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - This study aimed to characterize somatic mutation profiles and their association with clinical outcomes in patients with metastatic castration-sensitive prostate cancer treated with enzalutamide. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male Key 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 Key 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 Target Size - 70

Recruitment Status: Recruitment status - Main results already published Date of protocol fixation - 2021 Year 04 Month 16 Day Date of IRB - 2021 Year 09 Month 22 Day Anticipated trial start date - 2021 Year 09 Month 22 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069089

Disclaimer: Curated by HT Syndication.