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Salivary Duct CarcinomaPhase 2DUCTNCT05513365

Phase II Dutasteride in Combination With CAB vs CAB in SDC

A Phase 2 study testing Goserelin 10.8 mg, Bicalutamide 50 mg and Dutasteride 0.5 mg in people with Salivary Duct Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Salivary Duct Carcinoma
What is being tested?
Goserelin 10.8 mg, Bicalutamide 50 mg and Dutasteride 0.5 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteNetherlands
Study dates
27 Sep 2022to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically/histologically proven diagnosis of (incurable) AR+ R/M salivary duct carcinoma
  • AR positive diseases (strong expression in at least 1% of nuclei of neoplastic cells based on central IHC review)
  • 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).
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  • Adequate bone marrow function:
  • WBC ≥ 3.5/10^9 /L
  • Absolute neutrophil count (ANC) ≥ 1.5x10^9/L
  • Hemoglobin ≥ 6.20 mmol/L
  • Platelet count ≥ 100x10^9/L
  • Adequate liver function:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN) OR ≤ 5.0 times ULN for patients with liver metastases
  • Bilirubin ≤ 1.5 times ULN. For patients known with Gilbert's Syndrome ≤ 3.0 times ULN is permitted.
  • Adequate renal function:
  • Serum creatinine level ≤ 1.5 times ULN or calculated creatinine clearance ≥ 30 mL/min based on CKD-EPI-GFR
  • Adequate cardiac function

Who cannot join

  • 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
  • Patients familiar with Long QT-syndrome (LQTS)
  • Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
  • Patients that are pregnant or lactating
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  • Patients with uncontrolled illness including:
  • Cardiovascular disorders, including symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias
  • Uncontrolled hypertension (defined as sustained systolic BP > 160 mm Hg, or diastolic BP > 100 mm Hg. Unless evidence of white-coat hypertension)
  • Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before inclusion
  • Serious active infections
  • Patients undergoing concomitant treatments including:
  • Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation
  • Concomitant (or within 6 months before inclusion) administration of any 5-alpha reductase inhibitor, i.e. dutasteride or finasteride
  • Concurrent treatment with any other anti-cancer therapy within the last 4 weeks before inclusion
  • Curative radiation therapy within the last 4 weeks before inclusion or palliative radiation therapy 1 week before start of study
  • Any condition which, in the opinion of the investigator, would preclude participation in this clinical study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

C.M.L. Van Herpen, Prof. MD. PhD. contact

+31243611111

Jetty.Weijers@radboudumc.nl

Netherlands1 site, 1 recruiting

  • Radboudumc

    Nijmegen, Gelderland, 6500HB

    Jetty AM Weijers, MSc, +31243611111, Jetty.Weijers@radboudumc.nl

    Carla ML van Herpen, MD, PhD

    Recruiting

Other trials in Netherlands

About this study

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

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.

Read the detailed 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.

Being tested
Goserelin 10.8 mg, Bicalutamide 50 mg, Dutasteride 0.5 mg
Keywords
Salivary duct carcinoma, Androgen deprivation therapy, Combined androgen blockade, Dutasteride, Goserelin, Bicalutamide, anti-androgens

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goserelin 10.8 mgDrug

    Also called Zoladex

    Goserelin injection (10.8 mg) once per 3 months until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

  • Bicalutamide 50 mgDrug

    Also called Casodex

    Bicalutamide tablets (50 mg) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

  • Dutasteride 0.5 mgDrug

    Also called Avodart

    Dutasteride capsules (0.5 mg) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

Study groups in NCT05513365
Study groupRoleWhat they receive
Combined androgen blockade (CAB) + dutasterideExperimentalPatients from cohort B (ADT-resistant) will receive CAB+dutasteride.
Receives: Drug: Goserelin 10.8 mg; Drug: Bicalutamide 50 mg; Drug: Dutasteride 0.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    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.

    Measured: 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

  2. Duration of Response (DoR)

    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.

    Measured: 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

Secondary outcomes (11)

  1. Progression Free Survival (PFS)

    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.

    Measured: 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

  2. Clinical benefit rate (CBR)

    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.

    Measured: 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

  3. Overall survival (OS)

    The OS is defined as the time from study enrolment to the date of death to any cause.

    Measured: 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

  4. Quality of Life (QoL) based on the EORTC QLQ-C30 questionnaire

    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.

    Measured: 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

  5. Quality of Life (QoL) based on the EORTC QLQ-H&N43 questionnaire

    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.

    Measured: 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

  6. Quality of Life (QoL) based on the EORTC QLQ-SHQ22 questionnaire

    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.

    Measured: 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

  7. Pain level assessed by the VAS (visual analog scale) questionnaire

    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.

    Measured: 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

  8. Adverse Events according to CTCAE v5.0

    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)

    Measured: 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

  9. Circulating tumor DNA (ctDNA) levels

    ctDNA levels will be assessed to evaluate whether treatment response and disease progression can be predicted. Baseline, 3 months, 6 months, and at PD.

    Measured: through study completion, estimated after 3 years

  10. mRNA expression levels of AR and AR splice variants

    mRNA expression of AR and AR splice variants on baseline and post-treatment tumor tissue samples to evaluate whether treatment response and disease progression can be predicted. Pre-treatment and post-treatment (i.e. PD)

    Measured: through study completion, estimated after 3 years

  11. mRNA expression levels of SRD5A1/SRD5A2

    mRNA expression of SRD5A1/SRD5A2 on baseline and post-treatment tumor tissue samples to evaluate whether treatment response and disease progression can be predicted. Pre-treatment and post-treatment (i.e. PD)

    Measured: through study completion, estimated after 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start27 Sep 2022
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Patients will be included into two cohorts based on their previous treatments, either ADT-naïve (cohort A) or ADT-resistant patients (cohort B). In cohort A, the randomization will result in the allocation of the control arm (goserelin and bicalutamide) and experimental arm (goserelin, bicalutamide, and dutasteride) in a 1:1 ratio. In cohort B, patients ADT-resistant will be enrolled receiving similar therapy to the experimental arm, i.e. goserelin, bicalutamide, and dutasteride. Cohort A is closed for inclusion as of April 18, 2024.
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05513365
Sponsor's protocol ID
MOHN22
Other IDs
1140022110057
Acronym
DUCT
Status last verified
Nov 2024
First submitted
18 Aug 2022
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Weijers JAM, Verhaegh GW, Lassche G, van Engen-van Grunsven ACH, Driessen CML, van Erp NP, Jonker MA, Schalken JA, van Herpen CML. 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. BMC Cancer. 2024 Sep 20;24(1):1174. doi: 10.1186/s12885-024-12889-0.

    PubMed 39304797

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Goserelin 10.8 mg, Bicalutamide 50 mg and Dutasteride 0.5 mg in people with Salivary Duct Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact C.M.L. Van Herpen, Prof. MD. PhD. (+31243611111, Jetty.Weijers@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05513365, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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