TriangleNCT02975934 · OUTCOME
Time to Prostate Specific Antigen (PSA) Progression 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 (up to approximately 5 years)
What was measured
Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.
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 | 5.7 | Not reported | 4.6 | 6.5 | Not reported |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 3.6 | Not reported | 3.2 | 4.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.6
- upper Limit
- 6.5
- value
- 5.7
- group Id
- OG001
- lower Limit
- 3.2
- upper Limit
- 4.5
- value
- 3.6
- denoms
- counts
- group Id
- OG000
- value
- 270
- group Id
- OG001
- value
- 135
- units
- Participants
- description
- Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.
- 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 (up to approximately 5 years)
- title
- Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice