Trial · NCT04191096
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 32 months | All randomized participants | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to approximately 32 months | All randomized participants | Months | MEDIAN |
| SECONDARY | Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST) | Up to Approximately 32 months | All randomized participants | Months | MEDIAN |
| SECONDARY | Time to First Symptomatic Skeletal-related Event (TTSSRE) | Up to Approximately 32 months | All randomized participants | Months | MEDIAN |
| SECONDARY | Time to Prostate-specific Antigen (PSA) Progression | Up to Approximately 32 months | All randomized participants | Months | MEDIAN |
| SECONDARY | Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of PCWG-Modified RECIST 1.1 as Assessed by BICR | Up to Approximately 32 months | All randomized participants | Months | MEDIAN |
| SECONDARY | Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item #3 (Worst Pain in 24 Hours) and Opiate Use | Up to Approximately 32 months | All randomized participants who received at least one dose of study treatment, and who had at least 1 BPI-SF assessment | Months | MEDIAN |
| SECONDARY | Time From Randomization to Disease Progression as Determined by Investigator Assessment After Next-line of Therapy or Death From Any Cause, Whichever Occurs First (PFS2) | Up to Approximately 32 months | All randomized participants | Months | MEDIAN |
| SECONDARY | Prostate-specific Antigen (PSA) Response Rate | Up to Approximately 32 Months | All randomized participants who had a baseline PSA measurement and had data available for analysis | Percentage of participants | NUMBER |
| SECONDARY | Prostate-specific Antigen (PSA) Undetectable | Up to Approximately 32 Months | All randomized participants with detectable PSA at baseline and had data available for analysis | Percentage of Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) Per PCWG-Modified RECIST 1.1 as Assessed by BICR | Up to Approximately 32 Months | All randomized participants with measurable disease at baseline and had data available for analysis | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per PCWG- Modified RECIST 1.1 as Assessed by BICR | Up to Approximately 32 Months | All randomized participants who demonstrated a CR or PR, and had data available for analysis | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experience an Adverse Event (AE) | Up to Approximately 59 Months | |||
| SECONDARY | Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | Up to Approximately 59 Months |
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/NCT04191096/outcomes