A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice

About This Trial

This study observes how well a prostate cancer medicine called darolutamide works in everyday life when combined with standard hormone therapy, with or without chemotherapy.
It is open to men with advanced prostate cancer that has spread to other parts of the body but still responds to hormone treatments, and whose doctors have already decided to prescribe this medication.
Because this is an observational study, you will receive your usual medical care without having to undergo extra procedures, tests, or clinic visits.
Researchers will simply collect information from your routine appointments to see how the treatment controls the cancer and affects your day-to-day quality of life.

More Information

This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen deprivation therapy (ADT), with or without docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The study aims to enroll approximately 1,600 male patients (800 per cohort) from multiple countries, primarily in Europe, who have a diagnosis of mHSPC and for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment.
The primary objective is to estimate the proportion of patients achieving undetectable prostate-specific antigen (PSA) levels (<0.2 ng/mL) at 1 year of treatment in each cohort.
Secondary objectives include describing patient demographics, clinical characteristics, prior and concomitant treatments, adverse events, and clinical effectiveness measures such as overall survival, time to new treatment, time to castration resistance, and time to PSA progression.
Further objectives involve assessing quality of life, reasons for not adding docetaxel, outcomes by patient subgroups (e.g., Gleason score, disease volume, ECOG status), genomic testing results, and hospitalization rates.
Data will be collected using electronic case report forms (eCRF) during routine clinical practice, with no additional diagnostic or monitoring procedures required beyond standard care.
All patients must provide informed consent prior to participation.
The study will comply with applicable regulatory requirements, including IEC/IRB approval in all participating countries.
Statistical analyses will be descriptive and exploratory, with interim analyses planned after 200, 400, and 600 patients per cohort have completed at least 12 months of treatment or discontinued therapy.
The study is expected to provide valuable insights into the real-world use of darolutamide in mHSPC, supporting clinical decision-making and enhancing understanding of treatment patterns, effectiveness, and safety in diverse patient populations.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study observes how well a prostate cancer medicine called darolutamide works in everyday life when combined with standard hormone therapy, with or without chemotherapy.

Study Details

Start Date: January 29, 2026
Lead Sponsor: Bayer

Full Eligibility Criteria

Inclusion Criteria

Male patient with a diagnosis of mHSPC
Male aged ≥18 years (or country's legal age of adulthood if >18 years)
Histologically or cytologically confirmed adenocarcinoma of prostate; may have begun ADT (up to 120 days prior to enrollment)
Metastatic disease by conventional or new generation imaging
Decision to initiate treatment with darolutamide with or without docetaxel made prior to enrollment
Signed informed patient consent before start of data collection
Life expectancy of ≥3 months based on clinical judgment

Exclusion Criteria

Participation in an investigational program with interventions outside of routine clinical practice
Contraindications according to local marketing authorization
Any prior treatment with second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, or other investigational AR inhibitors, cytochrome P17 enzyme inhibitor (except prior abiraterone acetate if discontinued at least 24 months before metastatic diagnosis) or other investigational CYP 17 enzyme inhibitors as antineoplastic treatment for prostate cancer.
Prior hormone therapy in the metastatic setting
Treatment with darolutamide initiated more than 7 days prior to enrollment