TriangleNCT00005044 · OUTCOME
Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (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
Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF \[protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy\], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are 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
Locoregional progression
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS x 8 Weeks | 6 | Not reported | 4 | 8 | Not reported |
| TAS x 28 Weeks | 4 | Not reported | 3 | 6 | Not reported |
Distant metastasis
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS x 8 Weeks | 6 | Not reported | 4 | 8 | Not reported |
| TAS x 28 Weeks | 6 | Not reported | 4 | 8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.05
- estimate Comment
- Reference level = TAS x 8 weeks
- group Description
- Locoregional progression
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.07
- param Type
- Hazard Ratio (HR)
- param Value
- 0.65
- statistical Comment
- 2-sided significance level = 0.05
- statistical Method
- Gray's test
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.66
- estimate Comment
- Reference level = TAS x 8 weeks
- group Description
- Distant metastasis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.80
- param Type
- Hazard Ratio (HR)
- param Value
- 1.07
- statistical Comment
- 2-sided significance level = 0.05
- statistical Method
- Gray's test
Complete source fields
- analyses
- ci Lower Limit
- 0.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.05
- estimate Comment
- Reference level = TAS x 8 weeks
- group Description
- Locoregional progression
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.07
- param Type
- Hazard Ratio (HR)
- param Value
- 0.65
- statistical Comment
- 2-sided significance level = 0.05
- statistical Method
- Gray's test
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.66
- estimate Comment
- Reference level = TAS x 8 weeks
- group Description
- Distant metastasis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.80
- param Type
- Hazard Ratio (HR)
- param Value
- 1.07
- statistical Comment
- 2-sided significance level = 0.05
- statistical Method
- Gray's test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4
- upper Limit
- 8
- value
- 6
- group Id
- OG001
- lower Limit
- 3
- upper Limit
- 6
- value
- 4
- title
- Locoregional progression
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4
- upper Limit
- 8
- value
- 6
- group Id
- OG001
- lower Limit
- 4
- upper Limit
- 8
- value
- 6
- title
- Distant metastasis
- denoms
- counts
- group Id
- OG000
- value
- 752
- group Id
- OG001
- value
- 737
- units
- Participants
- description
- Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF \[protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy\], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are 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
- Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice