Trial reportJMA journal2026
Triplet Therapy (Androgen Deprivation Therapy + Darolutamide + Biweekly Docetaxel) for High-risk Metastatic Castration-sensitive Prostate Cancer (TRIC Study): A Study Protocol for Open-labelled Single-Arm Phase II Clinical Trial.
Trial report in JMA journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
13 authors.
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Abstract
Background: Triplet therapy consisting of androgen deprivation therapy (ADT), docetaxel, and an androgen receptor signaling inhibitor (ARSI) has demonstrated survival benefits in patients with metastatic castration-sensitive prostate cancer (mCSPC), particularly those with high-risk disease. However, the feasibility of this intensive regimen is often limited by docetaxel-associated toxicity, especially in Japanese patients. Under the current Japanese health insurance system, darolutamide is the only ARSI approved for use in triplet therapy for mCSPC. Therefore, optimization of docetaxel administration is a key clinical issue. Methods: The triplet therapy (androgen deprivation therapy + darolutamide + biweekly docetaxel) for high-risk metastatic castration-sensitive prostate cancer (TRIC) study is an investigator-initiated, single-center, open-label, single-arm phase II clinical trial designed to evaluate the efficacy and safety of triplet therapy consisting of ADT, darolutamide, and biweekly low-dose docetaxel (35 mg/m Results: This study will prospectively assess the feasibility, safety, and early efficacy of the proposed triplet regimen. PSA response rates, survival outcomes, and treatment-related adverse events will be analyzed to generate preliminary evidence regarding treatment activity and tolerability in this high-risk population. Conclusions: The TRIC study will provide important prospective data on a modified triplet therapy tailored to the Japanese clinical setting. The findings are expected to inform future randomized trials and to contribute to the development of optimized treatment strategies for patients with high-risk mCSPC. Trial registration: Japan Registry of Clinical Trials (jRCTs) 041240151, registered: December 18, 2025.
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