Phase II Dutasteride in Combination With CAB vs CAB in SDC — DUCT  

Salivary Duct Carcinoma Clinical Trial

Official 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 Recurrent and/or Metastatic Salivary Duct Carcinoma - DUCT Study

Status Recruiting

Clinical Trial Summary

Phase 2 clinical trial on the addition of dutasteride to combined androgen blockade (CAB) therapy in recurrent and/or metastatic (R/M) salivary duct carcinoma (SDC) patients. The study included two cohorts of patients: Cohort A, which comprises ADT-naïve patients, and Cohort B, which comprises ADT-resistant patients. Cohort A is closed for inclusion as of April 18, 2024.

Clinical Trial Description

A prospective, randomized controlled, single-institution, phase II clinical trial to assess the objective response rate (ORR), duration of response (DoR), progression free survival (PFS), overall survival (OS), toxicity, quality of life (QoL), and expression of molecular targets of patients with R/M SDC treated with either combined androgen blockade (CAB; goserelin + bicalutamide) or CAB + dutasteride, Participants in Cohort A will be randomized 1:1 at the study entry to receive CAB (goserelin 10.8 mg/3months + bicalutamide 50 mg/once daily) or CAB + dutasteride (0.5 mg/once daily). Participants will receive treatment until until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw. Cohort A is closed for inclusion as of April 18, 2024. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ductal
• Salivary Duct Carcinoma

• NCT number: NCT05513365
• Study type: Interventional
• Source: Radboud University Medical Center
• Status: Recruiting
• Phase: Phase 2
• Start date: September 27, 2022
• Completion date: September 2027