TriangleNCT00005044 · OUTCOME
Disease-specific Survival (DSS) (10-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 randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
What was measured
Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.
Analysis population: Eligible patients with follow-up data
Groups in this outcome
TAS x 8 Weeks
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
TAS x 28 Weeks
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
| Group | Source count |
|---|---|
| TAS x 8 Weeks | 752 |
| TAS x 28 Weeks | 737 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS x 8 Weeks | 95 | Not reported | 93 | 97 | Not reported |
| TAS x 28 Weeks | 96 | Not reported | 95 | 98 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.48
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.39
- estimate Comment
- Reference level = TAS x 8 weeks
- group Description
- Assuming 40% of deaths in the 8-wk arm from prostate cancer (PC) and that 8-yr DSS would be 79%, 270 PC deaths were required to detect a 33% hazard reduction in the 28-wk arm with 90% power using the log-rank test with a 2-sided significance level of 0.05. Under assumed failure rates, 1,540 patients accrued over 4 years and observed for an additional 6 years were expected to provide the requisite events. This sample accounted for a 10% ineligible/lack-of-data rate and 3 interim analyses.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.45
- param Type
- Hazard Ratio (HR)
- param Value
- 0.81
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.48
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.39
- estimate Comment
- Reference level = TAS x 8 weeks
- group Description
- Assuming 40% of deaths in the 8-wk arm from prostate cancer (PC) and that 8-yr DSS would be 79%, 270 PC deaths were required to detect a 33% hazard reduction in the 28-wk arm with 90% power using the log-rank test with a 2-sided significance level of 0.05. Under assumed failure rates, 1,540 patients accrued over 4 years and observed for an additional 6 years were expected to provide the requisite events. This sample accounted for a 10% ineligible/lack-of-data rate and 3 interim analyses.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.45
- param Type
- Hazard Ratio (HR)
- param Value
- 0.81
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 93
- upper Limit
- 97
- value
- 95
- group Id
- OG001
- lower Limit
- 95
- upper Limit
- 98
- value
- 96
- denoms
- counts
- group Id
- OG000
- value
- 752
- group Id
- OG001
- value
- 737
- units
- Participants
- description
- Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- id
- OG000
- title
- TAS x 8 Weeks
- description
- TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- id
- OG001
- title
- TAS x 28 Weeks
- param Type
- NUMBER
- population Description
- Eligible patients with follow-up data
- reporting Status
- POSTED
- time Frame
- From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- title
- Disease-specific Survival (DSS) (10-year Rates Reported)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice