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

NCT07344779 | Not Yet Recruiting

• 1 other identifier: 23100
• Study Type: observational
• Target: 1,600
• Locations: 16 countries
• Sites: 16

Brief Summary

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.

Conditions

Metastatic Hormone-Sensitive Prostate Cancer

Keywords

Prostatic Neoplasms, Hormone-Sensitive/Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of patients in cohort 1 achieving undetectable PSA (<0.2 ng/mL) at 1 year

  To describe the effectiveness of darolutamide + ADT + docetaxel in patients with mHSPC by means of estimating the prostate-specific antigen (PSA) undetectable rates (PSA\<0.2 ng/mL) after 1 year of study treatment.

  after 1 year of treatment

• Proportion of patients in cohort 2 achieving undetectable PSA (<0.2 ng/mL) at 1 year

  To describe the effectiveness of darolutamide + ADT in patients with mHSPC by means of estimating the prostate-specific antigen (PSA) undetectable rates (PSA\<0.2 ng/mL) after 1 year of study treatment.

  after 1 year of treatment

Secondary Outcomes (64)

• Overall survival per cohort and per country

  up to 4 years

• Overall survival per cohort in all countries

  up to 4 years

• Time to subsequent treatment per cohort and per country

  up to 4 years

• Time to subsequent treatment per cohort in all countries

  up to 4 years

• Time to castration resistance (CRPC) per cohort and per country

  up to 4 years

Study Arms (2)

Darolutamide + ADT + Docetaxel (Triplet therapy)

This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with a combination of darolutamide, androgen deprivation therapy (ADT), and docetaxel. The decision to use this triplet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive all three treatments according to local standard of care.

Drug: Darolutamide (BAY 1841788); Drug: ADT; Drug: Docetaxel

Darolutamide + ADT (Doublet therapy)

This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with darolutamide and androgen deprivation therapy (ADT), but without docetaxel. The decision to use this doublet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive darolutamide and ADT according to local standard of care.

Drug: Darolutamide (BAY 1841788); Drug: ADT

Interventions

ADT DRUG

Androgen deprivation therapy administered per local standard of care.

Darolutamide + ADT (Doublet therapy); Darolutamide + ADT + Docetaxel (Triplet therapy)

Docetaxel DRUG

Docetaxel administered per local standard of care in combination with darolutamide and ADT for cohort 1.

Darolutamide + ADT + Docetaxel (Triplet therapy)

Darolutamide (BAY 1841788) DRUG

Darolutamide administered per local standard of care in combination with ADT.

Also known as: NUBEQA

Darolutamide + ADT (Doublet therapy); Darolutamide + ADT + Docetaxel (Triplet therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients with a diagnosis of metastatic hormone-sensitive prostate cancer (mHSPC) for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment.

You may qualify if:

• 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

You may not qualify if:

• Participation in an investigational program with interventions outside of routine clinical practice
• Contraindications according to local marketing authorization
• Any prior treatment with second-generation AR inhibitors (enzalutamide, apalutamide, or investigational AR inhibitors), CYP17 inhibitors (abiraterone acetate or investigational CYP17 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (16)

Many Locations

Multiple Locations, Belgium

Location

Many Locations

Multiple Locations, Finland

Location

Many Locations

Multiple Locations, France

Location

Many Locations

Multiple Locations, Germany

Location

Many Locations

Multiple Locations, Greece

Location

Many Locations

Multiple Locations, Israel

Location

Many Locations

Multiple Locations, Italy

Location

Many Locations

Multiple Locations, Lithuania

Location

Many Locations

Multiple Locations, Norway

Location

Many Locations

Multiple Locations, Poland

Location

Many Locations

Multiple Locations, Portugal

Location

Many Locations

Multiple Locations, Saudi Arabia

Location

Many Locations

Multiple Locations, Spain

Location

Many Locations

Multiple Locations, Sweden

Location

Many Locations

Multiple Locations, Switzerland

Location

Many Locations

Multiple Locations, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 15, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2030
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); GB (1); IL (1); BE (1); CH (1); ES (1); IT (1); GR (1); DE (1); SA (1); PT (1); PL (1); LI (1); SE (1); FI (1); NO (1)