TriangleNCT04689828 · 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
- 95% Confidence Interval
- Time frame
- median FU (randomization to event or censoring) 3.65 months (range 0-12.3)
What was measured
rPFS is defined as the time to radiographic progression by Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 as assessed by Blinded independent central (BICR) review or death.
Analysis population: The Full Analysis Set (FAS) comprised all participants to whom study treatment was assigned by randomization.
Groups in this outcome
177Lu-PSMA-617 (AAA617)
Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.
Androgen Receptor-directed Therapy (ARDT)
For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
| Group | Source count |
|---|---|
| 177Lu-PSMA-617 (AAA617) | 233 |
| Androgen Receptor-directed Therapy (ARDT) | 234 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 177Lu-PSMA-617 (AAA617) | 9.30 | Not reported | 6.77 | NA | NA: not able to calculate the upper bounds of the 95% Confidence Interval due to insufficient number of participants with events |
| Androgen Receptor-directed Therapy (ARDT) | 5.55 | Not reported | 4.04 | 5.95 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.56
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00000001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.41
- statistical Comment
- Stratified
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.56
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00000001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.41
- statistical Comment
- Stratified
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA: not able to calculate the upper bounds of the 95% Confidence Interval due to insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 6.77
- upper Limit
- NA
- value
- 9.30
- group Id
- OG001
- lower Limit
- 4.04
- upper Limit
- 5.95
- value
- 5.55
- denoms
- counts
- group Id
- OG000
- value
- 233
- group Id
- OG001
- value
- 234
- units
- Participants
- description
- rPFS is defined as the time to radiographic progression by Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 as assessed by Blinded independent central (BICR) review or death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.
- id
- OG000
- title
- 177Lu-PSMA-617 (AAA617)
- description
- For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
- id
- OG001
- title
- Androgen Receptor-directed Therapy (ARDT)
- param Type
- MEDIAN
- population Description
- The Full Analysis Set (FAS) comprised all participants to whom study treatment was assigned by randomization.
- reporting Status
- POSTED
- time Frame
- median FU (randomization to event or censoring) 3.65 months (range 0-12.3)
- title
- Radiographic Progression Free Survival (rPFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice