A Randomized Phase II Trial on the Addition of Dutasteride to Combined Androgen Blockade Therapy Versus Combined Androgen Blockade Therapy Alone in Patients with Advanced or Metastatic Salivary Duct Carcinoma – The DUCT Study Protocol

    September 2024 in “ BMC Cancer ”
    Jetty A.M. Weijers, Gerald W. Verhaegh, Gerben Lassche, Adriana C. H. van Engen–van Grunsven, C.M.L. Driessen, Nielka P. van Erp, Marianne A. Jonker, Jack A. Schalken, Carla M.L. van Herpen
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    TLDR Adding dutasteride to therapy may improve treatment for advanced salivary duct cancer.
    The DUCT study is a phase II clinical trial investigating the addition of dutasteride to combined androgen blockade (CAB) therapy in patients with advanced or metastatic salivary duct carcinoma (SDC), a rare and aggressive cancer. The trial involves 98 patients divided into two cohorts: CAB-naïve patients and those with disease progression after prior CAB therapy. The study aims to determine if dutasteride, a steroid 5α-reductase 1 inhibitor, can improve response rates and clinical outcomes by enhancing androgen receptor signaling inhibition. Primary endpoints include objective response rate and duration of response, while secondary endpoints cover progression-free survival, overall survival, clinical benefit rate, quality of life, and safety. The trial could offer a new, cost-effective treatment option for SDC patients, particularly those with limited alternatives.
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