Trial · NCT05513365

Phase II Dutasteride in Combination With CAB vs CAB in SDC

NCT05513365, Phase 2, Recruiting, Radboud University Medical Center

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II Dutasteride in Combination With CAB vs CAB in SDC. Trials, record NCT05513365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05513365

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase II Dutasteride in Combination With CAB vs CAB in SDC
NCT number: NCT05513365
Status: Recruiting
Phases: Phase 2
Enrollment: 26 participants, estimated
Lead sponsor: Radboud University Medical Center
Conditions: Salivary Duct Carcinoma
Interventions: Goserelin 10.8 mg, Bicalutamide 50 mg, Dutasteride 0.5 mg
First posted: 2022-08-24
Last updated: 2025-06-04

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate (ORR)	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Response will be measured according to RECIST version 1.1, the ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient.
Primary	Duration of Response (DoR)	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Response will be measured according to RECIST version 1.1, the DoR is defined as the time from first tumor assessment at which the overall response was recorded as partial response (PR) or complete response (CR) that is subsequently confirmed until documented progressive disease (PD) or death form any cause, whichever occurs first.
Secondary	Progression Free Survival (PFS)	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Response will be measured according to RECIST version 1.1, the PFS is defined as the time from study enrolment until date of first documented disease progression or death due to any cause, whichever occurs first.Every 12 weeks a CT/MRI scan will be made to asses the progression free survival until PD.
Secondary	Clinical benefit rate (CBR)	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Response will be measured according to RECIST version 1.1, the CBR is defined as the confirmed CR or PR at any time or stable disease (SD) of at least 6 months. Every 12 weeks a CT/MRI scan will be made to asses the clinical benefit rate until PD.
Secondary	Overall survival (OS)	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years	The OS is defined as the time from study enrolment to the date of death to any cause.
Secondary	Quality of Life (QoL) based on the EORTC QLQ-C30 questionnaire	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Quality of Life (QoL) based on the EORTC QLQ-C30 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD.
Secondary	Quality of Life (QoL) based on the EORTC QLQ-H&N43 questionnaire	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Quality of Life (QoL) based on the EORTC QLQ-H\&N43 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD.
Secondary	Quality of Life (QoL) based on the EORTC QLQ-SHQ22 questionnaire	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Quality of Life (QoL) based on the EORTC QLQ-SHQ22 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD.
Secondary	Pain level assessed by the VAS (visual analog scale) questionnaire	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Scale range 0-10, in which a higher score represents more pain. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD.
Secondary	Adverse Events according to CTCAE v5.0	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Adverse events will be recorded using International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, the investigator will assess whether those events are drug related. Every OPD visit (every 3 months until PD)

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39304797	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05513365

GET https://conductscience.org/api/trials/v1/NCT05513365/registered

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