TriangleNCT00309985 · OUTCOME
Proportion of Patients With PSA Complete Response (CR) at 6 Months
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed at 6 months
What was measured
PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.
Analysis population: All randomized patients
Groups in this outcome
Androgen-Deprivation Therapy and Docetaxel
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Androgen-Deprivation Therapy Alone
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
| Group | Source count |
|---|---|
| Androgen-Deprivation Therapy and Docetaxel | 397 |
| Androgen-Deprivation Therapy Alone | 393 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Androgen-Deprivation Therapy and Docetaxel | 0.320 | Not reported | 0.274 | 0.369 | Not reported |
| Androgen-Deprivation Therapy Alone | 0.196 | Not reported | 0.158 | 0.239 | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.274
- upper Limit
- 0.369
- value
- 0.320
- group Id
- OG001
- lower Limit
- 0.158
- upper Limit
- 0.239
- value
- 0.196
- denoms
- counts
- group Id
- OG000
- value
- 397
- group Id
- OG001
- value
- 393
- units
- Participants
- description
- PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Androgen-Deprivation Therapy and Docetaxel
- description
- Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
- id
- OG001
- title
- Androgen-Deprivation Therapy Alone
- param Type
- NUMBER
- population Description
- All randomized patients
- reporting Status
- POSTED
- time Frame
- Assessed at 6 months
- title
- Proportion of Patients With PSA Complete Response (CR) at 6 Months
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice