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

NCT07395804 | Not Yet Recruiting FDA Drug

• 1 other identifier: 23146
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Outcome Measures

Primary Outcomes (1)

• Number of participants with PSA < 0.2 ng/mL

  12 months

Secondary Outcomes (14)

• 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

  at study start

• Number of participants with certain clinical characteristics

  at study start

• Number of participants with certain testosterone value

  at study start

Study Arms (1)

Men with mHSPC fulfilling the inclusion and exclusion criteria

Drug: Darolutamide plus ADT treatment

Interventions

Darolutamide plus ADT treatment DRUG

Darolutamide + Androgen-deprivation therapy (ADT) according to local label and treating physician

Men with mHSPC fulfilling the inclusion and exclusion criteria

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

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

You may qualify if:

• 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 plus ADT was made as per investigtor'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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Locations

Multiple, Germany

Location

MeSH Terms

Interventions

darolutamide

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

18888422937; 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: February 2, 2026
• First Posted: February 9, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2031
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)