Trial · NCT07344779
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 66
Download this page as JSON| 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). |
| Secondary | PSA response rate per cohort and per country | 1 year | Proportion of patients with blood PSA level \<0.2 ng/mL, confirmed by a second subsequent PSA value \<0.2 ng/mL 3 or more weeks later |
| Secondary | PSA response rate per cohort in all countries | 1 year | Proportion of patients with blood PSA level \<0.2 ng/mL, confirmed by a second subsequent PSA value \<0.2 ng/mL 3 or more weeks later |
| Secondary | Survival rate per cohort and per country | up to 4 years | Survival rate at specified time points. |
| Secondary | Survival rate per cohort and all countries | up to 4 years | Survival rate at specified time points. |
| Secondary | Time to discontinuation per cohort and per country | up to 4 years | Time from start of darolutamide treatment to permanent discontinuation or death |
| Secondary | Time to discontinuation per cohort in all countries | up to 4 years | Time from start of darolutamide treatment to permanent discontinuation or death |
| Secondary | Reason for discontinuation percohort and per country | up to 4 years | Reason for permanent darolutamide discontinuation |
| Secondary | Reason for discontinuation per cohort in all countries | up to 4 years | Reason for permanent darolutamide discontinuation |
| Secondary | Patient demographics per cohort and per country | at baseline | Demographic characteristics at the first documented regular visit ion the study, referred to as baseline). |
| Secondary | Patient demographics per cohort in all countries | at baseline | Demographic characteristics at the first documented regular visit ion the study, referred to as baseline). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT07344779/registered