Trial · NCT07344779
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, Recruiting, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07344779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07344779
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT07344779
- Status
- Recruiting
- Enrollment
- 1,600 participants, estimated
- Lead sponsor
- Bayer
- Conditions
- Metastatic Hormone-Sensitive Prostate Cancer
- Interventions
- Darolutamide (BAY 1841788), ADT, Docetaxel
- First posted
- 2026-01-15
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients in cohort 1 achieving undetectable PSA (<0.2 ng/mL) at 1 year | after 1 year of treatment | 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. |
| Primary | Proportion of patients in cohort 2 achieving undetectable PSA (<0.2 ng/mL) at 1 year | after 1 year of treatment | 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. |
| Secondary | Overall survival per cohort and per country | up to 4 years | Time from start of darolutamide treatment until death from any cause. |
| Secondary | Overall survival per cohort in all countries | up to 4 years | Time from start of darolutamide treatment until death from any cause. |
| Secondary | Time to subsequent treatment per cohort and per country | up to 4 years | Time from start of darolutamide treatment to initiation of a new anti-cancer therapy. |
| Secondary | Time to subsequent treatment per cohort in all countries | up to 4 years | Time from start of darolutamide treatment to initiation of a new anti-cancer therapy. |
| Secondary | Time to castration resistance (CRPC) per cohort and per country | up to 4 years | Time from enrollment until documented clinical or PSA progression with testosterone level \<50 ng/dL or documented medical/surgical castration. |
| Secondary | Time to castration resistance (CRPC) per cohort in all countries | up to 4 years | Time from enrollment until documented clinical or PSA progression with testosterone level \<50 ng/dL or documented medical/surgical castration. |
| Secondary | Time to PSA progression per cohort and per country | up to 4 years | Time from start of darolutamide treatment to PSA progression (≥25% increase above nadir and ≥2 ng/mL, confirmed by a second value ≥3 weeks later, but prior to 6 months, while on treatment). |
| Secondary | Time to PSA progression per cohort in all countries | up to 4 years | Time from start of darolutamide treatment to PSA progression (≥25% increase above nadir and ≥2 ng/mL, confirmed by a second value ≥3 weeks later, but prior to 6 months, while on treatment). |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07344779
GET https://conductscience.org/api/trials/v1/NCT07344779/registered?page=2