TriangleNCT03511664 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization until date of death from any cause, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) and up to 66 months (Final Analysis cut-off date = 14-Dec-2023)
What was measured
Overall Survival (OS) was defined as the time (in months) from the date of randomization to the date of death due to any cause. If the patient was not known to have died, then OS was censored. The censoring date was date of the last study visit, or contact, until the cut-off date. The cut-off date was not used for last contact date, unless the patient was seen or contacted on that date. Final OS was analyzed at the time of Primary analysis (Primary Analysis cut-off date = 27-Jan-2021) and an updated descriptive analysis of OS was re-run at the time of final analysis (Final Analysis cut-off date 14-Dec-2023).
Analysis population: Full Analysis Set (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) | 551 |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 280 |
Reported measurements
Primary OS Analysis
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 15.3 | Not reported | 14.2 | 16.9 | Not reported |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 11.3 | Not reported | 9.8 | 13.5 | Not reported |
Final OS analysis
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 15.3 | Not reported | 14.2 | 16.9 | Not reported |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 11.5 | Not reported | 9.9 | 13.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.74
- group Description
- Primary OS Analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.62
- statistical Comment
- one-sided stratified log-rank test
- statistical Method
- Log Rank
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.81
- estimate Comment
- Cox PH model stratified by LDH (≤260 vs. \>260 IU/L), liver metastases (yes/no), ECOG score (0-1 vs. 2), and NAAD inclusion in best supportive care at randomization (yes/no). IRT data used for stratification
- group Description
- Final OS analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 0.68
Complete source fields
- analyses
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.74
- group Description
- Primary OS Analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.62
- statistical Comment
- one-sided stratified log-rank test
- statistical Method
- Log Rank
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.81
- estimate Comment
- Cox PH model stratified by LDH (≤260 vs. \>260 IU/L), liver metastases (yes/no), ECOG score (0-1 vs. 2), and NAAD inclusion in best supportive care at randomization (yes/no). IRT data used for stratification
- group Description
- Final OS analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 0.68
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.2
- upper Limit
- 16.9
- value
- 15.3
- group Id
- OG001
- lower Limit
- 9.8
- upper Limit
- 13.5
- value
- 11.3
- title
- Primary OS Analysis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.2
- upper Limit
- 16.9
- value
- 15.3
- group Id
- OG001
- lower Limit
- 9.9
- upper Limit
- 13.5
- value
- 11.5
- title
- Final OS analysis
- denoms
- counts
- group Id
- OG000
- value
- 551
- group Id
- OG001
- value
- 280
- units
- Participants
- description
- Overall Survival (OS) was defined as the time (in months) from the date of randomization to the date of death due to any cause. If the patient was not known to have died, then OS was censored. The censoring date was date of the last study visit, or contact, until the cut-off date. The cut-off date was not used for last contact date, unless the patient was seen or contacted on that date. Final OS was analyzed at the time of Primary analysis (Primary Analysis cut-off date = 27-Jan-2021) and an updated descriptive analysis of OS was re-run at the time of final analysis (Final Analysis cut-off date 14-Dec-2023).
- dispersion Type
- 95% 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
- Full Analysis Set (FAS)
- reporting Status
- POSTED
- time Frame
- From date of randomization until date of death from any cause, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) and up to 66 months (Final Analysis cut-off date = 14-Dec-2023)
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice