TriangleNCT00002874 · OUTCOME
Third PSA Recurrence (12-year Rates Reported)
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
- From start of salvage hormone therapy to 12 years.
What was measured
Third PSA recurrence rates (i.e. second PSA failure on study) were estimated by the cumulative incidence method, with failure defined as PSA value of 0.5ng/ml or higher or any disease progression after starting salvage hormone therapy. Patients alive without third PSA recurrence at time of analysis were censored. Death without third PSA recurrence was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
Analysis population: Eligible patients who did not withdraw consent and who started salvage hormone therapy.
Groups in this outcome
Placebo
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Bicalutamide
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
| Group | Source count |
|---|---|
| Placebo | 167 |
| Bicalutamide | 111 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 80.7 | Not reported | 73.2 | 86.3 | Not reported |
| Bicalutamide | 84.2 | Not reported | 75.0 | 90.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.46
- estimate Comment
- Reference level = placebo arm
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.213
- param Type
- Hazard Ratio (HR)
- param Value
- 1.11
- statistical Comment
- One-sided test
- statistical Method
- Gray's test
Complete source fields
- analyses
- ci Lower Limit
- 0.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.46
- estimate Comment
- Reference level = placebo arm
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.213
- param Type
- Hazard Ratio (HR)
- param Value
- 1.11
- statistical Comment
- One-sided test
- statistical Method
- Gray's test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 73.2
- upper Limit
- 86.3
- value
- 80.7
- group Id
- OG001
- lower Limit
- 75.0
- upper Limit
- 90.3
- value
- 84.2
- denoms
- counts
- group Id
- OG000
- value
- 167
- group Id
- OG001
- value
- 111
- units
- Participants
- description
- Third PSA recurrence rates (i.e. second PSA failure on study) were estimated by the cumulative incidence method, with failure defined as PSA value of 0.5ng/ml or higher or any disease progression after starting salvage hormone therapy. Patients alive without third PSA recurrence at time of analysis were censored. Death without third PSA recurrence was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Radiation therapy (64.8 Gy) + placebo (daily 2 years)
- id
- OG000
- title
- Placebo
- description
- Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
- id
- OG001
- title
- Bicalutamide
- param Type
- NUMBER
- population Description
- Eligible patients who did not withdraw consent and who started salvage hormone therapy.
- reporting Status
- POSTED
- time Frame
- From start of salvage hormone therapy to 12 years.
- title
- Third PSA Recurrence (12-year Rates Reported)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice