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Proliferation of SDC relies on androgen receptor (AR) signalling, prompting the use of combined androgen blockade (CAB, <jats:italic>i.e.<\/jats:italic>, luteinizing hormone-releasing hormone agonist and\/or AR antagonists) to R\/M SDC patients. However, only a subset of patients benefits from such treatments. We have shown that response to CAB is associated with <jats:italic>steroid 5\u03b1-reductase 1<\/jats:italic> (<jats:italic>SRD5A1<\/jats:italic>) mRNA expression. SRD5A1 catalyses the intracellular conversion of testosterone into the more potent AR-agonist dihydrotestosterone. This conversion can be inhibited by dutasteride, a potent SRD5A1-inhibitor, which is currently prescribed for benign prostatic hyperplasia. We hypothesize that repurposing dutasteride to target AR signalling in SDC could enhance therapeutic response and clinical outcome in SDC patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This prospective, open-label, randomized controlled phase II clinical trial, is designed to investigate whether dutasteride as an adjunct drug to CAB improves response rate and clinical outcome in patients with AR-positive R\/M SDC. Patients are divided in two cohorts based on their prior systemic treatments. In cohort A, CAB-na\u00efve patients (<jats:italic>n<\/jats:italic>\u2009=\u200974) will be randomly assigned to either a control arm (Arm 1) receiving CAB (goserelin 10.8\u00a0mg\/3m and bicalutamide 50\u00a0mg\/OD) or an experimental arm (Arm 2) where dutasteride (0.5\u00a0mg\/OD) is added to the CAB regimen. In cohort B, patients with disease progression after adjuvant or first-line palliative CAB therapy (max. <jats:italic>n<\/jats:italic>\u2009=\u200924) will receive goserelin, bicalutamide, and dutasteride to assess whether the addition of dutasteride can overcome therapy resistance. The primary endpoints are the objective response rate and duration of response. Secondary endpoints are progression-free survival, overall survival, clinical benefit rate, quality of life, and safety. Translational research will be performed to explore molecular target expression differences and their correlation with clinical outcome.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>The DUCT study addresses an unmet medical need by investigating the repurposing of dutasteride to enhance treatment response and improve clinical outcome for patients with R\/M SDC, especially those with limited alternative treatment options, such as HER2-negative cases. By repurposing a registered low-cost drug, this trial\u2019s findings could be readily applied into clinical practice.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>Clinicaltrials.gov Identifier: NCT05513365. Date of registration: August 24, 2022.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Protocol version<\/jats:title>\n                <jats:p>Current protocol version 4.0, February 21, 2024.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12885-024-12889-0","type":"journal-article","created":{"date-parts":[[2024,9,20]],"date-time":"2024-09-20T12:02:54Z","timestamp":1726833774000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["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 \u2013 the DUCT study protocol"],"prefix":"10.1186","volume":"24","author":[{"given":"Jetty A. 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The data will be collected and processed in accordance with the General Data Protection Regulation (EU) 2016\/679 and in compliance with national requirements on data protection, Dutch Personal Data Protection Act (WBP). The current ethics approval is granted by the medical research Ethics Committees United (MEC-U) as of August 11, 2022, by Clinical Trials Information System (CTIS) [reference EU CT-number: 2022\u2013500745-24\u201300]. The trial has been registered with ClinicalTrials.gov [NCT05513365; date of registration August 24, 2022]. Oral and written informed consent will be obtained from all subjects prior to any study related procedures. Informed consent will be written, dated, and signed by the treating physician, and by the subject or, when the subject is not able to give informed consent, their legally designated representative. Subjects also provide additional consent for the use of data and biological specimens collected as part of this trial for the use in ancillary studies to SGC.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"JW, GV, GL, AvEvG, CD, MJ: No competing interests.NvE: Research grants (institution): Astellas and Ipsen.JS: Speakers honorarium: \u2018Astellas, Bayer.\u2019CvH: Advisory (institution): Bayer, Bristol-Myers Squibb, Ipsen, MSD, Regeneron,. Research grant (institution): Astra Zeneca, Bristol-Myers Squibb, MSD, Merck, Ipsen, Novartis, and Sanofi.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"1174"}}