How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany (23146)

DAROlutamide DoUBlet Therapy in Daily Practice (DARO-DUB) - Real-world Evaluation of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Treated With Darolutamide Plus ADT in Germany

Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive prostate cancer (mHSPC).

The usual treatment for this stage of prostate cancer is hormone therapy (called androgen-deprivation therapy or ADT) combined with another medicine that blocks the effect of male hormones on cancer cells, known as an androgen-receptor pathway inhibitor. Darolutamide is a newer type of androgen-receptor inhibitor.

The main goal of this study is to find out how well a combination of two treatments-darolutamide and hormone therapy (also called androgen-deprivation therapy or ADT)-works for men in Germany who have advanced prostate cancer that has spread to other parts of the body and still responds to hormone treatment. The study will look at how many men have very low or undetectable levels of a protein called prostate-specific antigen (PSA) in their blood after 12 months of treatment. PSA is a marker that doctors use to check how active prostate cancer is.

The study will also look at how long men live after starting this treatment, and will collect information about their health, the type of prostate cancer they have, and any other medicines they are taking. The study will last for 5 years. At the start of the study, the study doctor will collect information about each patient's background, such as age, other health problems, and details about their prostate cancer. This information will be taken from the patient's medical records if available. If some information is missing, the doctor may ask the patient directly.

Other information will be collected as the study goes on. This includes details about the patient's treatment, how they are doing during their regular medical visits, and any changes in their health. These check-ups and data collection will happen as part of the patient's usual care, including at the beginning of treatment, during treatment visits, follow-up visits, and at the end of the study observation period.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
• Intervention / Treatment: Drug: darolutamide plus ADT treatment

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: 18888422937; Email: clinical-trials-contact@bayer.com

Study Locations

• Germany
  • Locations, Germany
    • Recruiting
    • Many

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Men with metastatic hormone-sensitive mHSPC fulfilling the inclusion and exclusion criteria

Description

Inclusion Criteria:

• Male patients aged ≥ 18 years
• Diagnosis of mHSPC with histological or cytological evidence for adenocarcinoma of prostate

• Metastatic disease by conventional or new generation imaging

  • Physician decision to initiate treatment with Darolutamide+ADT was made as per investigator's routine treatment practice prior to enrollment in the study
  • Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).

Exclusion Criteria:

• Darolutamide treatment started more than 30 days prior to study enrollment
• ADT treatment started more than 12 weeks before the start of treatment with darolutamide plus ADT
• Hypersensitivity to darolutamide or any other excipient
• Other prior systemic hormonal or anti-cancer treatment for mHSPC
• Participation in an investigational program for prostate cancer with interventions outside of routine clinical practice

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Men with mHSPC fulfilling the inclusion and exclusion criteria	Drug: darolutamide plus ADT treatment; 2*300 mg darolutamide twice daily + ADT treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with PSA < 0.2 ng/mL	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of deaths or participants with end of observation		up to 60 months
Number of participants with PSA < 0.2 ng/mL		3, 6, and 9 months
Number of participants with certain demographic characteristics	age; race	at study start
Number of participants with certain clinical characteristics	comorbities; Gleason score/ISUP; PSA prior therapy; prostate cancer volume and risk; type of metastatic disease; ECOG performance	at study start
Number of participants with certain testosterone value		at study start
Kind of ADT treatment		up to 60 months
Number of participants who change ADT treatment		up to 60 months
Number of participants who change dosage of Darolutamide treatment		up to 60 months
Number of participants with certain subsequent anti-cancer therapies		up to 60 months
Number of participants with treatment-emergent adverse events		from start of treatment up to 60 months
Duration of Darolutamide+ADT treatment		up to 60 months
Timing of Darolutamide+ADT treatment start		up to 60 months
Number of participants with certain reasons for darolutamide plus ADT treatment discontinuation		up to 60 months
Number of participants with certain concomitant medication at study start and changes during treatment with darolutamide plus ADT		up to 60 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): February 15, 2031
• Study Completion (Estimated): February 15, 2031

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 21, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: darolutamide
• Other Study ID Numbers: 23146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No