Trial · NCT05694819
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Darolutamide monotherapy group: Objective response rate(ORR) assessed by investigators | Up to 13 month | The proportion of patients with confirmed tumor response of complete response (CR) or partial response (PR) per RECIST 1.1, as assessed by investigators |
| Primary | Darolutamide and Goserelin combination therapy group: Objective response rate(ORR) assessed by an Independent Review Committee | Up to 13 month | The proportion of patients with confirmed tumor response of CR or PR per RECIST 1.1, as assessed by an independent review committee |
| Secondary | Duration of Response (DOR) | Up to 13 month | DOR will be defined among responders from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease as defined in RECIST version 1.1 or death, whichever occurred first. |
| Secondary | Best Overall Response (BOR) | Up to 13 month | BOR will be defined as the best response recorded from the start of protocol treatment based on RECIST version 1.1 |
| Secondary | Disease Control Rate (DCR) | Up to 13 month | DCR will be defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or SD for at least 6 weeks based on RECIST version 1.1. |
| Secondary | Clinical Benefit Rate (CBR) | Up to 13 month | CBR will be defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or stable disease (SD) for at least 24 weeks based on RECIST version 1.1. |
| Secondary | Clinical Benefit Duration (CBD) | Up to 13 month | CBD will be defined the period starting from the date of enrollment (start of treatment) and ending on the earlier of the date of determination of progression, the date of death from any cause, or the end of the study period. |
| Secondary | Progression-Free Survival (PFS) | Up to 13 month | PFS will be defined as the time from the date of the initial dose of study intervention to the date of first documented disease progression as defined in the RECIST version 1.1, or death due to any cause, whichever occurred first. |
| Secondary | Overall Survival (OS) | Up to 13 month | OS will be defined as the time from the date of the initial dose of study intervention to the date of the participant's death |
| Secondary | Adverse events | Up to 30 days after the last dose | All adverse events, adverse events with undeniable causal relationship to the investigational drug, severe adverse events (SAEs) and SAEs with undeniable causal relationship to the investigational drug will be evaluated based on CTCAE version 5.0 |
| Secondary | Quality of Life assessed using the EuroQol-5Dimention-5Level (EQ-5D-5L) questionnaire | Up to 30 days after the last dose | Changes from baseline to each time point in health-related quality of life will be measured using the European Quality of Life Five Dimension Five Level Scale Assessment Questionnaire (EQ-5D-5L). The EQ-5D-5L consists of a description and a health assessment. The health description consists of five dimensions (mobility, self-care, normal activities, pain / discomfort, and anxiety / depression), with each dimension identifying five levels of severity \[best (1) - worst (5)\]. Health assessment is assessed using a visual analogue scale (VAS)(\[worse (0) - better (100)\]. |
| Secondary | Darolutamide monotherapy group: ORR assessed by an Independent Review Committee | Up to 13 month | The proportion of patients with confirmed tumor response of CR or PR per RECIST 1.1, as assessed by an independent review committee |
| Secondary | Darolutamide and Goserelin combination therapy group: ORR assessed by investigators | Up to 13 month | The proportion of patients with confirmed tumor response of complete response (CR) or partial response (PR) per RECIST 1.1, as assessed by investigators |
| Secondary | Comparison of androgen receptor (AR) test results in Darolutamide and Goserelin combination therapy group | Baseline | Comparison of AR test results between each institutional and a central assessment |
| Secondary | Positivity of Ki-67 in Darolutamide and Goserelin combination therapy group | Baseline | The proportion of patients who have high expression of Ki-67 by a central assessment |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05694819/registered