TriangleNCT02319837 · OUTCOME
Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) 2 Years After Suspension of Treatment at Week 37 Due to Undetectable PSA
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 until 2 years after Week 37 (up to Month 34)
What was measured
Undetectable PSA at 36 weeks was serum PSA levels \<0.2 ng/mL at Week 36. At Week 37, study treatment was suspended for participants whose PSA values were undetectable (\<0.2 ng/mL) at Week 36 as determined by the central laboratory. Study treatment may have been suspended only once (at Week 37) due to undetectable PSA and was reinitiated if subsequent central laboratory PSA values increased to ≥2.0 ng/mL for participants with prior prostatectomy or ≥5.0 ng/mL for participants without prostatectomy. Percentage of participants with undetectable PSA 2 years after suspension of treatment at Week 37 due to undetectable PSA was calculated as the number of participants with undetectable PSA 2 years after suspension of treatment at Week 37 due to undetectable PSA divided by the number of participants with treatment suspension and multiplied by 100.
Analysis population: All participants in the ITT population (randomly assigned to study treatment) who had treatment suspension.
Groups in this outcome
Enzalutamide + Leuprolide
Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
Placebo + Leuprolide
Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
Enzalutamide Monotherapy
Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
| Group | Source count |
|---|---|
| Enzalutamide + Leuprolide | 321 |
| Placebo + Leuprolide | 240 |
| Enzalutamide Monotherapy | 304 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide + Leuprolide | 16.8 | Not reported | 12.9 | 21.4 | Not reported |
| Placebo + Leuprolide | 9.6 | Not reported | 6.2 | 14.0 | Not reported |
| Enzalutamide Monotherapy | 4.6 | Not reported | 2.5 | 7.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.8
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0089
- p Value Comment
- P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.
- param Type
- difference of percentage of participants
- param Value
- 7.2
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -9.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.6
- group Ids
- OG001
- OG002
- non Inferiority Type
- OTHER
- p Value
- 0.0326
- p Value Comment
- P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.
- param Type
- difference of percentage of participants
- param Value
- -5.0
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.8
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0089
- p Value Comment
- P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.
- param Type
- difference of percentage of participants
- param Value
- 7.2
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -9.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.6
- group Ids
- OG001
- OG002
- non Inferiority Type
- OTHER
- p Value
- 0.0326
- p Value Comment
- P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.
- param Type
- difference of percentage of participants
- param Value
- -5.0
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.9
- upper Limit
- 21.4
- value
- 16.8
- group Id
- OG001
- lower Limit
- 6.2
- upper Limit
- 14.0
- value
- 9.6
- group Id
- OG002
- lower Limit
- 2.5
- upper Limit
- 7.6
- value
- 4.6
- denoms
- counts
- group Id
- OG000
- value
- 321
- group Id
- OG001
- value
- 240
- group Id
- OG002
- value
- 304
- units
- Participants
- description
- Undetectable PSA at 36 weeks was serum PSA levels \<0.2 ng/mL at Week 36. At Week 37, study treatment was suspended for participants whose PSA values were undetectable (\<0.2 ng/mL) at Week 36 as determined by the central laboratory. Study treatment may have been suspended only once (at Week 37) due to undetectable PSA and was reinitiated if subsequent central laboratory PSA values increased to ≥2.0 ng/mL for participants with prior prostatectomy or ≥5.0 ng/mL for participants without prostatectomy. Percentage of participants with undetectable PSA 2 years after suspension of treatment at Week 37 due to undetectable PSA was calculated as the number of participants with undetectable PSA 2 years after suspension of treatment at Week 37 due to undetectable PSA divided by the number of participants with treatment suspension and multiplied by 100.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
- id
- OG000
- title
- Enzalutamide + Leuprolide
- description
- Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
- id
- OG001
- title
- Placebo + Leuprolide
- description
- Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
- id
- OG002
- title
- Enzalutamide Monotherapy
- param Type
- NUMBER
- population Description
- All participants in the ITT population (randomly assigned to study treatment) who had treatment suspension.
- reporting Status
- POSTED
- time Frame
- From randomization until 2 years after Week 37 (up to Month 34)
- title
- Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) 2 Years After Suspension of Treatment at Week 37 Due to Undetectable PSA
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice