Darolutamide with hormone therapy (± chemotherapy) in metastatic hormone-sensitive prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an international, prospective, observational study that follows patients treated with darolutamide in combination with androgen deprivation therapy, with or without docetaxel, in routine clinical practice. The study aims to describe real-world effectiveness and safety in approximately 1,600 men across multiple countries, focusing on PSA response at 1 year. Data collected include patient demographics, disease characteristics, prior and concurrent treatments, adverse events, and survival outcomes. Enrollment is limited to patients for whom the treating physician has already decided to initiate darolutamide treatment. No interventional procedures are mandated; treatment decisions are at the discretion of local clinicians.

Why it matters

Who can join: the full rules

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

Where it's running

• Many Locations
  Many Locations, Belgium Recruiting
• Many Locations
  Many Locations, Finland Recruiting
• Many Locations
  Many Locations, France Recruiting
• Many Locations
  Many Locations, Greece Recruiting
• Many Locations
  Many Locations, Israel Recruiting
• Many Locations
  Many Locations, Italy Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JUR-003 in adults with advanced prostate cancer

  This first-in-human study tests JUR-003 to see if it is safe and tolerable and to get an early sense of activity in adults with metastatic or advanced prostate cancer.

  Recruiting at 4 sites Phase 1 TCG Labs Soleil · Grand Rapids, Michigan and 3 other locations · NCT07824349

• Tracking apalutamide use in men with metastatic hormone-sensitive prostate cancer in France

  This project will see if men with metastatic hormone-sensitive prostate cancer in France take apalutamide as prescribed during their first year of treatment.

  Recruiting Janssen Cilag S.A.S. · Caen · NCT07451002

• ASP5541 with prednisone and ADT for Chinese men with prostate cancer

  This study tests whether giving ASP5541 together with prednisone and ongoing androgen-deprivation therapy is safe and how the medicine behaves in Chinese men with metastatic prostate cancer.

  Recruiting Phase 1 Astellas Pharma Inc · Beijing, Beijing Municipality · NCT07339267

• Intensifying Treatment With Docetaxel and Apalutamide for Metastatic Hormone-Sensitive Prostate Cancer After a Partial PSA Response

  This trial tests whether adding docetaxel to apalutamide and ADT helps men with metastatic hormone-sensitive prostate cancer who did not achieve a deep PSA response after initial apalutamide treatment.

  Recruiting Phase 3 Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD · Bayonne and 55 other locations · NCT07333066

• Phase 2 test of ASP5541 for men with advanced prostate cancer

  This study will test whether an injectable form of abiraterone (ASP5541) is safe and works as well or better than the standard oral abiraterone for men with metastatic prostate cancer who are on hormone therapy, with or without prednisone.

  Recruiting at 54 sites Phase 2 Astellas Pharma Inc · Huntsville, Alabama and 53 other locations · NCT07005154

• Observing the safety of darolutamide in Korean men with prostate cancer

  This study is testing the safety of darolutamide in Korean men with prostate cancer to see how well it works as part of their regular treatment.

  Recruiting Bayer · Many Locations · NCT06334120

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.