Trial · NCT06991556
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prostate Specific Antigen 90 (PSA90) Rate | From date of randomization till 30 days safety fup, assessed up to approximately 75 months | Prostate Specific Antigen 90 (PSA90) Rate is defined as the proportion of participants who achieve a ≥90% decrease in PSA from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between. |
| Primary | Incidence rate of adverse events (AEs) | From date of randomization till 30 days safety fup, assessed up to approximately 75 months | The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0. |
| Primary | Number of participants with dose adjustments | From date of randomization till 30 days safety fup, assessed up to approximately 75 months | The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm. |
| Primary | Duration of exposure to study treatment | From date of randomization till 30 days safety fup, assessed up to approximately 75 months | The duration of exposure in weeks to study treatment and for each study treatment component (JSB462, abiraterone and enzalutamide) will be summarized for each study treatment component by means of descriptive statistics using the SAS. |
| Secondary | Radiographic Progression Free Survival (rPFS) | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 83 months | Radiographic Progression Free Survival (rPFS) is defined as the time between randomization and the first occurrence of disease progression (per PCWG3-modified RECIST 1.1 as assessed by the investigator) or death due to any cause |
| Secondary | Overall Survival (OS) | From date of randomization until date of death from any cause, assessed up to approximately 83 months | Overall Survival (OS) is defined as the time between randomization and death due to any cause |
| Secondary | Incidence rate of adverse events (AEs) | From date of randomization till 30 days safety fup, assessed up to approximately 83 months | The analysis of adverse events and laboratory abnormalities will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0. |
| Secondary | Overall Response Rate (ORR) | From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 83 months | Overall Response Rate (ORR) is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) per PCWG3-modified RECIST 1.1 as assessed by the investigator |
| Secondary | Disease Control Rate (DCR) | From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 83 months | Disease Control Rate (DCR) is defined as the proportion of participants achieving a CR, PR or stable disease (SD) per PCWG3-modified RECIST 1.1 as assessed by the investigator |
| Secondary | Duration of Response (DOR) | From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 83 months | Duration of Response (DOR) is defined as the time between first documented CR/PR and disease progression or death due to any cause per PCWG3-modified RECIST 1.1 as assessed by the investigator |
| Secondary | Time to Response (TTR) | From date of randomization until date of first documented Complete Response (CR) or Partial Response (PR), assessed up to approximately 83 months | Time to response (TTR) is defined as the time from randomization to the date of first documented CR or PR per PCWG3-modified RECIST 1.1 as assessed by the investigator |
| Secondary | Time to soft tissue progression (TTSTP) | From date of randomization until date of soft tissue radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 83 months | Time to soft tissue progression (TTSTP) is defined as the time from randomization to the date of first documented radiographic soft tissue progression per PCWG3-modified RECIST 1.1 as assessed by the investigator |
| Secondary | Prostate Specific Antigen 30 (PSA30) Rate | From date of randomization till 30 days safety fup, assessed up to approximately 75 months | Prostate Specific Antigen 30 (PSA30) Rate is defined as the proportion of participants who achieve a ≥30% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between |
| Secondary | Prostate Specific Antigen 50 (PSA50) Rate | From date of randomization till 30 days safety fup, assessed up to approximately 75 months | Prostate Specific Antigen 50 (PSA50) Rate is defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between |
| Secondary | Prostate Specific Antigen 0 (PSA0) Rate | From date of randomization till 30 days safety fup, assessed up to approximately 75 months | Prostate Specific Antigen 0 (PSA0) Rate is defined as the proportion of participants who achieve a PSA level \<0.2 ng/ml at any timepoint after start of treatment, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between |
| Secondary | Duration of biochemical response (DBR) | From date of date of first PSA50 response until date of PSA progression or death from any cause, assessed up to approximately 83 months | Duration of biochemical response (DBR) is defined as the time between PSA90 and/or PSA0 and PSA progression (increase ≥25% in PSA and an absolute increase of ≥2 ng/mL from NADIR) or death due to any cause |
| Secondary | Time to first symptomatic skeletal event (TTSSE) | From date of randomization till EOT or death, whichever happens first, assessed up to approximately 83 months | Time to first symptomatic skeletal event (TTSSE) is defined as the date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first |
| Secondary | Plasma concentrations of JSB462 and plasma concentrations of its metabolite ARV-767 | Day 1 of Cycles 1 and 2: Pre-dose/0h and Post-dose 4h +/- 1h. Day 1 of Cycles 3 to 8: Pre-dose/0h. End of Treatment Visit (EOT): Anytime. 1 cycle = 28 days. | JSB462 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels in JSB462 treatment arms. |
| Secondary | Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | From randomization up till 30 day safety Follow-up, assessed up to approximately 83 months | The PRO-CTCAE is a patient-reported outcomes measurement system developed by the National Cancer Institute as a companion to the CTCAE. It includes items covering participant-reported symptomatic adverse events (AEs) from the CTCAE. Each symptomatic AE concept has up to three items evaluating frequency, severity, or interference, focused on the study population and treatment regimens. Participants respond on a 5-point scale for each item: * Frequency: Never, Rarely, Occasionally, Frequently, Almost constantly * Severity: None, Mild, Moderate, Severe, Very severe * Interference: Not at all, A little bit, Somewhat, Quite a bit, Very much The past 7-day recall version is used, focusing on relevant symptoms like fatigue, diarrhea, and hot flashes. |
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.
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