do_not_disturb_altRecruitment Complete

Metastatic hormone-sensitive prostate cancer (mHSPC)

Bayer Identifier:

22523

ClinicalTrials.gov Identifier:

NCT06010914

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to learn more about how safe Darolutamide is under real-world conditions in participants with Metastatic Hormone-Sensitive Prostate Cancer

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

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

Trial summary

Enrollment Goal
100
Trial Dates
October 2023 - January 2027
Phase
Phase 4
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many LocationsMany Locations, Japan

Primary Outcome

  • 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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    From the start of darolutamide treatment to 30 days after the last dose of docetaxel

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    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. o Baseline characteristics (vital signs, Gleason Score, ECOG PS, PSA) o Prostate cancer history o Prior and ongoing Co-morbidities o Darolutamide, GnRH agonist/antagonist, docetaxel use: ▪ Initiation and termination dates and reasons for ending treatment.
    date_rangeTime Frame:
    From the start of darolutamide treatment to 30 days after the last dose of docetaxel
  • Descriptive summary of dosing patterns of darolutamide
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    From the start of darolutamide treatment to 30 days after the last dose of docetaxel
  • Dose modifications due to AEs
    Dosing patterns.
    date_rangeTime Frame:
    From the start of darolutamide treatment to 30 days after the last dose of docetaxel

Trial design

Drug use investigation of darolutamide in addition to standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC)
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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