TriangleNCT02975934 · OUTCOME
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
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
- From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
What was measured
The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria (Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).
Analysis population: ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC).
Groups in this outcome
Rucaparib
Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
Abiraterone Acetate or Enzalutamide or Docetaxel
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
| Group | Source count |
|---|---|
| Rucaparib | 270 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 135 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rucaparib | 10.2 | Not reported | 8.3 | 11.2 | Not reported |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 6.4 | Not reported | 5.6 | 8.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.61
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.61
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- 11.2
- value
- 10.2
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 8.2
- value
- 6.4
- denoms
- counts
- group Id
- OG000
- value
- 270
- group Id
- OG001
- value
- 135
- units
- Participants
- description
- The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria (Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
- id
- OG000
- title
- Rucaparib
- description
- Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
- id
- OG001
- title
- Abiraterone Acetate or Enzalutamide or Docetaxel
- param Type
- MEDIAN
- population Description
- ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC).
- reporting Status
- POSTED
- time Frame
- From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
- title
- Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice