account_circleRecruiting
Metastatic hormone-sensitive prostate cancer (mHSPC)
Bayer Identifier:
22523
ClinicalTrials.gov Identifier:
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.
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
MaleAge
18 - N/ATrial summary
Enrollment Goal
100Trial Dates
October 2023 - January 2027Phase
Phase 4Could I Receive a placebo
NoProducts
Nubeqa (Darolutamide, BAY1841788)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many Locations | Many 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 TEAEsCausal 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 TEAEsAction 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/characteristicsAll 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 darolutamidedate_rangeTime Frame:From the start of darolutamide treatment to 30 days after the last dose of docetaxel
- Outcomes of AEsCausal 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 AEsDosing patterns.date_rangeTime Frame:From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A