TriangleNCT03511664 · OUTCOME
Radiographic Progression-free Survival (rPFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 99.2% Confidence Interval
- Time frame
- From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
What was measured
Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of randomization to the date of radiographic disease progression based on the central review assessment per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause. Patients who were alive without radiographic progression at the analysis data cut-off were censored for rPFS at the time of their last evaluable radiographic assessment. Date of censoring for rPFS: 1) The censoring date was the date when the last evaluable radiographic assessment (CT/MRI/bone scan) determined a lack of progression; 2) If there were no evaluable assessments, censoring occurred at the date of randomization; 3) Patients who had 2 or more consecutive missed tumor assessments immediately prior to PD or death were censored at the date of the last evaluable tumor assessment prior to those missing tumor assessments.
Analysis population: PFS Full Analysis Set (PFS-FAS)
Groups in this outcome
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
| Group | Source count |
|---|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 385 |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 196 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 8.7 | Not reported | 7.9 | 10.8 | Not reported |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 3.4 | Not reported | 2.4 | 4.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.2
- ci Upper Limit
- 0.57
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.40
- statistical Comment
- one-sided stratified log-rank test
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.2
- ci Upper Limit
- 0.57
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.40
- statistical Comment
- one-sided stratified log-rank test
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.9
- upper Limit
- 10.8
- value
- 8.7
- group Id
- OG001
- lower Limit
- 2.4
- upper Limit
- 4.0
- value
- 3.4
- denoms
- counts
- group Id
- OG000
- value
- 385
- group Id
- OG001
- value
- 196
- units
- Participants
- description
- Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of randomization to the date of radiographic disease progression based on the central review assessment per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause. Patients who were alive without radiographic progression at the analysis data cut-off were censored for rPFS at the time of their last evaluable radiographic assessment. Date of censoring for rPFS: 1) The censoring date was the date when the last evaluable radiographic assessment (CT/MRI/bone scan) determined a lack of progression; 2) If there were no evaluable assessments, censoring occurred at the date of randomization; 3) Patients who had 2 or more consecutive missed tumor assessments immediately prior to PD or death were censored at the date of the last evaluable tumor assessment prior to those missing tumor assessments.
- dispersion Type
- 99.2% Confidence Interval
- groups
- description
- Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
- id
- OG000
- title
- Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
- description
- Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
- id
- OG001
- title
- Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
- param Type
- MEDIAN
- population Description
- PFS Full Analysis Set (PFS-FAS)
- reporting Status
- POSTED
- time Frame
- From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- title
- Radiographic Progression-free Survival (rPFS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice