Phase II Dutasteride in Combination With CAB vs CAB in SDC

What Was Tested

This registered phase 2 trial tested Goserelin.

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.

It had 1 arm (groups): Combined androgen blockade (CAB) + dutasteride (experimental).

Patients from cohort B (ADT-resistant) will receive CAB+dutasteride.

The registry classes the interventions as drug.

More on the Plan

Participants will receive treatment until until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

Who Took Part

26 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Pathologically/histologically proven diagnosis of (incurable) AR+ R/M salivary duct carcinoma. Measurable disease per RECIST version 1.1 at baseline. Appendix II. Age ≥ 18 years. Written informed consent must be given according to national/local regulation. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix III).

The full record lists 17 inclusion and 17 exclusion criteria; among the exclusions: patients with history of allergic reactions attributed to compounds of similar chemical or biological composition to goserelin, bicalutamide or dutasteride; patients with peanut or soy allergy (dutasteride capsules contain lecithin which may contain soy oil); patients who do not have adequate swallowing capacity.

How the Study Was Run

It was run as a sequential and open-label study.

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

It started in 2022-09-27 with completion listed for 2025-09.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Overall Response Rate (ORR). Duration of Response (DoR).

It also tracked 11 secondary outcomes, for example Progression Free Survival (PFS), Overall survival (OS), Quality of Life (QoL) based on the EORTC QLQ-C30 questionnaire, Quality of Life (QoL) based on the EORTC QLQ-H&N43 questionnaire, Quality of Life (QoL) based on the EORTC QLQ-SHQ22 questionnaire and Pain level assessed by the VAS (visual analog scale) questionnaire.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Goserelin in 26 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.