A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer (DADOX)

Drug Use Investigation of Darolutamide in Addition to Standard Androgen Deprivation Therapy (ADT) and Docetaxel in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

This is an observational study in which only data are collected from participants receiving their usual treatment.

In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Metastatic means that the cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (ADT). ADT lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells.

Men with mHSPC and who have been decided by their own doctors to be treated with darolutamide in combination with ADT and docetaxel can join this study. Darolutamide works by blocking the testosterone signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer. It works by stopping the growth and spread of cancer cells.

Darolutamide in combination with docetaxel and ADT is an approved treatment for men with mHSPC. It was approved based on a study called ARASENS. More information is needed on how safe darolutamide is when given with ADT and docetaxel in Japanese men with mHSPC.

The main purpose of this study is to collect information about the safety of this combination treatment in Japanese participants with mHSPC under real-world conditions.

The main information that researchers will collect:

Number and severity of heart-related medical problems participants have during the treatment

Other information that researchers will collect:

Number and severity of all medical problems participants have during the study

Age and other information about the participants such as their illness, medical history, and other medicines taken at the same time

Treatment pattern of darolutamide such as the amount of medicine given, the duration for which it is given, and any changes made to the treatment

Data will be collected from August 2023 to July 2026. Researchers will observe participants from the start of darolutamide treatment until 30 days after they receive their last dose of docetaxel, which is expected to be approximately 6 months for each participant.

In this study, data from regular health visits will be collected. No visits or tests are required as part of this study.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Japan
  • Multiple Locations, Japan
    • Recruiting
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male patients with a diagnosis of mHSPC will be enrolled after the decision for treatment with darolutamide in combination with docetaxel and ADT has been made by the physician or a delegate.

Description

Inclusion Criteria:

• Men over the age of 18 years
• Histologically or cytologically confirmed adenocarcinoma prostate cancer
• Metastatic disease confirmed either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan
• Patients diagnosed with mHSPC by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with darolutamide plus ADT and docetaxel therapy by the investigator under routine clinical practice
• ADT (GnRH agonist/antagonist or orchiectomy) before or simultaneous treatment with darolutamide
• Signed informed consent

Exclusion Criteria:

• Participation in an investigational program with interventions outside of routine clinical practice
• Contraindications according to the local marketing authorization
• Previous treatment with darolutamide

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mHSPC patients to treat with darolutamide in combination with docetaxel and ADT; Patients over the age of 18 years with a diagnosis of mHSPC and for whom a decision to treat with darolutamide in combination with docetaxel and ADT has been made by the treating physician before study enrollment.	Other: No Intervention; Following the manner of observational study, no intervention will be provided in the study. The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with cardiac treatment-emergent adverse events (TEAEs)	Incidence of cardiac disorders (TEAEs based on MedDRA SOC), including severity, seriousness, onset date and outcome.	From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Outcomes of cardiac TEAEs	Causal relationship (i.e. if a specific AE is related to daroluatmide) between darolutamide and cardiac disorders.	From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Dose modifications due to cardiac TEAEs	Action taken related to darolutamide (dose modifications and time periods).	From the start of darolutamide treatment to 30 days after the last dose of docetaxel

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	Occurrence of AEs, including severity, seriousness, onset date and outcome. Adverse event (AE): Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship (association) with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the product, whether or not related to the product.	From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Patient demographics/characteristics	All background data such as patient demographics, diagnosis and prior treatment, past medical history, concomitant diseases, and concomitant medications.; Baseline characteristics (vital signs, Gleason Score, ECOG PS, PSA); Prostate cancer history; Prior and ongoing Co-morbidities; Darolutamide, GnRH agonist/antagonist, docetaxel use:Initiation and termination dates and reasons for ending treatment.	From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Descriptive summary of dosing patterns of darolutamide		From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Outcomes of AEs	Causal relationship (i.e. if a specific AE is related to daroluatmide) between darolutamide and AE/ADR, and action taken related to darolutamide (dose modifications and time periods).	From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Dose modifications due to AEs	Dosing patterns.	From the start of darolutamide treatment to 30 days after the last dose of docetaxel

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypersensitivity; Prostatic Neoplasms
• Other Study ID Numbers: 22523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No