Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Recurrence

Carcinoma, Ductal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Goserelin

Androgen Antagonists

Bicalutamide

Dutasteride

Antineoplastic Agents, Hormonal

Hormones

Hormone Antagonists

5-alpha Reductase Inhibitors

Enzyme Inhibitors

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

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

Goserelin 10.8 mg

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

Bicalutamide 50 mg

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

Dutasteride 0.5 mg

Jetty AM Weijers, MSc

Carla ML van Herpen, MD, PhD

Jack A Schalken, PhD

Gerald W Verhaegh, PhD

Carla van Herpen, MD, PhD

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.

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.

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.

Phase II Dutasteride in Combination With CAB vs CAB in SDC

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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)

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

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)

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)

ZonMw: The Netherlands Organisation for Health Research and Development

Radboud University Medical Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

Prolactin Release-Inhibiting Factors

Glucocorticoids

Cytochrome P-450 Enzyme Inhibitors

All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus abiraterone acetate and prednisone, as per standard of care. Goserelin 10.8 mg will be used once per 12 weeks. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone once per day. Subjects will continue to take abiraterone acetate and prednisone for 24 weeks before robotic assisted radical prostatectomy

All subjects in this arm will receive LHRHa alone for 24 weeks before receiving robotic assisted radical prostatectomy. Goserelin 10.8 mg will be administered once per 12 weeks.

1000 mg orally daily for 24 weeks before robotic assisted radical prostatectomy

5 mg oral low dose prednisone, once daily

10.8 mg goserelin hypodermic once per 12 weeks

Hongqian Guo, MD

High risk prostate cancer (PCa) had worse outcomes on radical treatment results, short-time oncological results, even cancer-specific survival, than those low or mediate risk PCa. Neoadjuvant treatment before radical prostatectomy had been proven to get some benefits on peri-operation results, especially on reduction of tumor volume and minimization of biochemical recurrence. This study will evaluate the efficacy and safety of androgen deprivation therapy (ADT) with abiraterone in neoadjuvant therapy for surgically resectable high-risk or very high-risk PCa.

Neoadjuvant Therapy of Abiraterone Plus ADT for High Risk Prostate Cancer

Medical Ethics Committee of Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy

The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy

Clinical or pathological stage degradation after neoadjuvant therapy

The proportion of subjects with positive surgical margins after radical prostatectomy

The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 6 months of treatment

The proportion of subjects whose PSA has never gone below 1 ng/ml or who receive any radiotherapy or systemic treatment after radical prostatectomy

The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm

The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.

biochemical recurrence-free survival (bRFS) defined as time to PSA ≥ 0.2 ng/ml after radical prostatectomy.

time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Dutasteride in Combination With CAB vs CAB in SDC	NCT05513365	Salivary Duct C...	Goserelin 10.8 ... Bicalutamide 50... Dutasteride 0.5...	18 Years -	Radboud University Medical Center
Neoadjuvant Therapy of Abiraterone Plus ADT for High Risk Prostate Cancer	NCT04356430	Prostate Cancer	Abiraterone Ace... Prednisone Goserelin 10.8 ...	18 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Phase II Dutasteride in Combination With CAB vs CAB in SDC	NCT05513365	Salivary Duct C...	Goserelin 10.8 ... Bicalutamide 50... Dutasteride 0.5...	18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for goserelin 10.8 mg