TriangleNCT05551117 · OUTCOME
Part 1: Prostate-specific Cancer Antigen (PSA) Response Rate Per PCWG3 Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 4 weeks throughout study participation. Average duration 10 months.
What was measured
PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.
Analysis population: All participants in Part 1 who received at least one dose of study treatment, with a baseline PSA ≥ 2 ng/mL and at least one post-baseline PSA measurement (PSA Response Evaluable Population). There were no participants in the Control Arm that were part of the PSA Response Evaluable Population. Participants in Part 2 did not have mCRPC, so were not assessed using PSA measurement.
Groups in this outcome
Part 1: MGC018 2.0 mg (Arm A)
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
Part 1: MGC018 2.7 mg (Arm B)
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
| Group | Source count |
|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 83 |
| Part 1: MGC018 2.7 mg (Arm B) | 71 |
| Part 1: Control Arm | 0 |
| Part 2 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 45.8 | Not reported | 34.8 | 57.1 | Not reported |
| Part 1: MGC018 2.7 mg (Arm B) | 38.0 | Not reported | 26.8 | 50.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.8
- upper Limit
- 57.1
- value
- 45.8
- group Id
- OG001
- lower Limit
- 26.8
- upper Limit
- 50.3
- value
- 38.0
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 71
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
- id
- OG000
- title
- Part 1: MGC018 2.0 mg (Arm A)
- description
- vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
- id
- OG001
- title
- Part 1: MGC018 2.7 mg (Arm B)
- description
- abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
- id
- OG002
- title
- Part 1: Control Arm
- description
- vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
- id
- OG003
- title
- Part 2
- param Type
- NUMBER
- population Description
- All participants in Part 1 who received at least one dose of study treatment, with a baseline PSA ≥ 2 ng/mL and at least one post-baseline PSA measurement (PSA Response Evaluable Population). There were no participants in the Control Arm that were part of the PSA Response Evaluable Population. Participants in Part 2 did not have mCRPC, so were not assessed using PSA measurement.
- reporting Status
- POSTED
- time Frame
- Every 4 weeks throughout study participation. Average duration 10 months.
- title
- Part 1: Prostate-specific Cancer Antigen (PSA) Response Rate Per PCWG3 Criteria
- type
- SECONDARY
- unit Of Measure
- percent
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice