TriangleNCT02485691 · OUTCOME
Percentage of Participants With Prostate Specific Antigen (PSA) Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to PSA response, death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
What was measured
PSA response was defined as \>= 50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later.
Analysis population: Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with PSA level \>2 ng/mL at baseline, and with at least two post-baseline assessments before any further anti-cancer therapy for specified outcome measure.
Groups in this outcome
Cabazitaxel
Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
Abiraterone Acetate or Enzalutamide
Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
| Group | Source count |
|---|---|
| Cabazitaxel | 113 |
| Abiraterone Acetate or Enzalutamide | 105 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel | 36.3 | Not reported | 27.4 | 45.1 | Not reported |
| Abiraterone Acetate or Enzalutamide | 14.3 | Not reported | 7.6 | 21.0 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Comment
- A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0003
- p Value Comment
- Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Comment
- A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0003
- p Value Comment
- Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.4
- upper Limit
- 45.1
- value
- 36.3
- group Id
- OG001
- lower Limit
- 7.6
- upper Limit
- 21.0
- value
- 14.3
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 105
- units
- Participants
- description
- PSA response was defined as \>= 50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
- id
- OG000
- title
- Cabazitaxel
- description
- Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
- id
- OG001
- title
- Abiraterone Acetate or Enzalutamide
- param Type
- NUMBER
- population Description
- Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with PSA level \>2 ng/mL at baseline, and with at least two post-baseline assessments before any further anti-cancer therapy for specified outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline up to PSA response, death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
- title
- Percentage of Participants With Prostate Specific Antigen (PSA) Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice