Clinical trial NCT06010914: A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer
Official title: Drug Use Investigation of Darolutamide in Addition to Standard Androgen Deprivation Therapy (ADT) and Docetaxel in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with cardiac treatment-emergent adverse events (TEAEs)
timeFrame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
measure: Outcomes of cardiac TEAEs
timeFrame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
measure: Dose modifications due to cardiac TEAEs
timeFrame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
measure: Patient demographics/characteristics
timeFrame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
measure: Descriptive summary of dosing patterns of darolutamide
timeFrame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
measure: Outcomes of AEs
timeFrame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
measure: Dose modifications due to AEs
timeFrame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many Locations
Study officials:
References: