TriangleNCT01308567 · OUTCOME
Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)
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
- Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
What was measured
Time to PSA-PFS: time interval between date of randomization \& first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA \<10 ng/mL):(a)in participants with baseline PSA\>0 ng/mL\&\<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.
Analysis population: Analysis was performed on ITT population which included all randomized participants.
Groups in this outcome
Docetaxel 75 mg/m^2
Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Cabazitaxel 20 mg/m^2
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
| Group | Source count |
|---|---|
| Docetaxel 75 mg/m^2 | 391 |
| Cabazitaxel 20 mg/m^2 | 389 |
| Cabazitaxel 25 mg/m^2 | 388 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Docetaxel 75 mg/m^2 | 8.3 | Not reported | 7.66 | 9.20 | Not reported |
| Cabazitaxel 20 mg/m^2 | 8.2 | Not reported | 7.43 | 8.90 | Not reported |
| Cabazitaxel 25 mg/m^2 | 9.2 | Not reported | 8.44 | 9.92 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.123
- estimate Comment
- Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2
- group Description
- Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.948
- ci Lower Limit
- 0.886
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.238
- estimate Comment
- Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2
- group Description
- Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.047
Complete source fields
- analyses
- ci Lower Limit
- 0.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.123
- estimate Comment
- Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2
- group Description
- Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.948
- ci Lower Limit
- 0.886
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.238
- estimate Comment
- Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2
- group Description
- Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.047
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.66
- upper Limit
- 9.20
- value
- 8.3
- group Id
- OG001
- lower Limit
- 7.43
- upper Limit
- 8.90
- value
- 8.2
- group Id
- OG002
- lower Limit
- 8.44
- upper Limit
- 9.92
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 391
- group Id
- OG001
- value
- 389
- group Id
- OG002
- value
- 388
- units
- Participants
- description
- Time to PSA-PFS: time interval between date of randomization \& first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA \<10 ng/mL):(a)in participants with baseline PSA\>0 ng/mL\&\<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
- id
- OG000
- title
- Docetaxel 75 mg/m^2
- description
- Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
- id
- OG001
- title
- Cabazitaxel 20 mg/m^2
- description
- Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
- id
- OG002
- title
- Cabazitaxel 25 mg/m^2
- param Type
- MEDIAN
- population Description
- Analysis was performed on ITT population which included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
- title
- Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice