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NCT07395804: 23146
How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany
trial testing Darolutamide plus ADT treatment in Metastatic Hormone-sensitive Prostate Cancer (mHSPC) in 500 participants. Not yet recruiting.
28 February 2031
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 28 February 2026 |
| Primary completion | 28 February 2031 |
| Estimated completion | 28 February 2031 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Darolutamide plus ADT treatment — full drug profile →
Conditions studied
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC) — all drugs for Metastatic Hormone-sensitive Prostate Cancer (mHSPC) →
Sponsor
Bayer — full company profile →
Who can join
18 and older, male only, with Metastatic Hormone-sensitive Prostate Cancer (mHSPC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07395804
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Currently open trials in the same condition.
- NCT07140900 — Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inh · Phase 1 · recruiting
- NCT06661122 — A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy a · recruiting
- NCT06479187 — PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer · Phase 4 · active not recruiting
- NCT06835218 — PROCARE - PROstate Cancer Real World Evidence Registry · recruiting
- NCT06010914 — A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone · active not recruiting
Other Bayer trials
Trials by the same sponsor.
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- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07395804 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 17 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07395804.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing