TriangleNCT05551117 · OUTCOME
Part 1: Time to PSA Progression Per PCWG3 Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 4 weeks throughout study participation. Average duration of participation, 10 months.
What was measured
In participants with a decrease in PSA from baseline, PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline, PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks. Time to PSA progression is defined as the time from the date of randomization to the first PSA progression.
Analysis population: The ITT population for Part 1 was used for this analysis. Only 3 of 7 participants were treated in the in the control arm. Of the 3 participants treated in the control arm, only 1 participant had an event. 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) | 91 |
| Part 1: MGC018 2.7 mg (Arm B) | 90 |
| Part 1: Control Arm | 1 |
| Part 2 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 5.9 | Not reported | 4.63 | 6.97 | Not reported |
| Part 1: MGC018 2.7 mg (Arm B) | 6.9 | Not reported | 4.83 | NA | The upper bound of the CI could not be estimated due to insufficient number of participants with event |
| Part 1: Control Arm | 4.6 | Not reported | NA | NA | 95% confidence interval could not be calculated for 1 participant. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.63
- upper Limit
- 6.97
- value
- 5.9
- comment
- The upper bound of the CI could not be estimated due to insufficient number of participants with event
- group Id
- OG001
- lower Limit
- 4.83
- upper Limit
- NA
- value
- 6.9
- comment
- 95% confidence interval could not be calculated for 1 participant.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 4.6
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 90
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- In participants with a decrease in PSA from baseline, PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline, PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks. Time to PSA progression is defined as the time from the date of randomization to the first PSA progression.
- 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
- MEDIAN
- population Description
- The ITT population for Part 1 was used for this analysis. Only 3 of 7 participants were treated in the in the control arm. Of the 3 participants treated in the control arm, only 1 participant had an event. 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 of participation, 10 months.
- title
- Part 1: Time to PSA Progression Per PCWG3 Criteria
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice