NCT02485691 · OUTCOME
Radiographic Progression-Free Survival (rPFS) in Participants With Presence and Absence of Biomarker
Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent · Source last updated 2022-05-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
What was measured
Circulating tumor cell (CTC) counts were considered as biomarker in a liquid biopsy. rPFS in participants with presence and absence of subtypes of CTC biomarker i.e. chromosomal instability (CIN) and neuroendocrine (NE) was reported in this outcome measure. rPFS was defined as: time (in months) from randomization to the first occurrence of any one of following: radiological tumor progressions (RECIST1.1), progression of bone lesions (PCWG2 criteria) or death due to any cause. Progression (RECIST1.1): at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with \>= 2 new lesions compared to Baseline observed \<12 weeks from randomization and confirmed by a second bone scan performed \>=6 weeks later; first bone scan with \>=2 new lesions compared to Baseline observed \>=12 weeks from randomization and new lesions were verified on next bone scan \>= 6 weeks later.
Analysis population: Analysis was performed on subset of participants analyzed according to the treatment group allocated by randomization with evaluable samples.
Groups in this outcome
Cabazitaxel
Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
Abiraterone Acetate or Enzalutamide
Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cabazitaxel | 109 |
|---|
| Abiraterone Acetate or Enzalutamide | 106 |
|---|
Reported measurements
Presence of CIN
Analysis denominator · Participants
| Group | Source count |
|---|
| Cabazitaxel | 27 |
|---|
| Abiraterone Acetate or Enzalutamide | 27 |
|---|
Values in months · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cabazitaxel | 4.2 | Not reported | 2.1 | 11.2 | Not reported |
|---|
| Abiraterone Acetate or Enzalutamide | 4.2 | Not reported | 0.03 | 21.0 | Not reported |
|---|
Absence of CIN
Analysis denominator · Participants
| Group | Source count |
|---|
| Cabazitaxel | 82 |
|---|
| Abiraterone Acetate or Enzalutamide | 79 |
|---|
Values in months · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cabazitaxel | 8.5 | Not reported | 0.03 | 33.1 | Not reported |
|---|
| Abiraterone Acetate or Enzalutamide | 3.4 | Not reported | 0.03 | 28.0 | Not reported |
|---|
Presence of NE
Analysis denominator · Participants
| Group | Source count |
|---|
| Cabazitaxel | 7 |
|---|
| Abiraterone Acetate or Enzalutamide | 14 |
|---|
Values in months · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cabazitaxel | 3.0 | Not reported | 2.6 | 11.2 | Not reported |
|---|
| Abiraterone Acetate or Enzalutamide | 3.9 | Not reported | 0.03 | 21.0 | Not reported |
|---|
Absence of NE
Analysis denominator · Participants
| Group | Source count |
|---|
| Cabazitaxel | 102 |
|---|
| Abiraterone Acetate or Enzalutamide | 92 |
|---|
Values in months · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cabazitaxel | 8.2 | Not reported | 0.03 | 33.1 | Not reported |
|---|
| Abiraterone Acetate or Enzalutamide | 3.5 | Not reported | 0.03 | 28.0 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 11.2
- value
- 4.2
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 21.0
- value
- 4.2
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Presence of CIN
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- upper Limit
- 33.1
- value
- 8.5
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 28.0
- value
- 3.4
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 79
- units
- Participants
- title
- Absence of CIN
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.6
- upper Limit
- 11.2
- value
- 3.0
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 21.0
- value
- 3.9
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 14
- units
- Participants
- title
- Presence of NE
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- upper Limit
- 33.1
- value
- 8.2
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 28.0
- value
- 3.5
- denoms
- counts
- group Id
- OG000
- value
- 102
- group Id
- OG001
- value
- 92
- units
- Participants
- title
- Absence of NE
- denoms
- counts
- group Id
- OG000
- value
- 109
- group Id
- OG001
- value
- 106
- units
- Participants
- description
- Circulating tumor cell (CTC) counts were considered as biomarker in a liquid biopsy. rPFS in participants with presence and absence of subtypes of CTC biomarker i.e. chromosomal instability (CIN) and neuroendocrine (NE) was reported in this outcome measure. rPFS was defined as: time (in months) from randomization to the first occurrence of any one of following: radiological tumor progressions (RECIST1.1), progression of bone lesions (PCWG2 criteria) or death due to any cause. Progression (RECIST1.1): at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with \>= 2 new lesions compared to Baseline observed \<12 weeks from randomization and confirmed by a second bone scan performed \>=6 weeks later; first bone scan with \>=2 new lesions compared to Baseline observed \>=12 weeks from randomization and new lesions were verified on next bone scan \>= 6 weeks later.
- dispersion Type
- Full Range
- groups
- description
- Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
- id
- OG000
- title
- Cabazitaxel
- description
- Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks)
- id
- OG001
- title
- Abiraterone Acetate or Enzalutamide
- param Type
- MEDIAN
- population Description
- Analysis was performed on subset of participants analyzed according to the treatment group allocated by randomization with evaluable samples.
- reporting Status
- POSTED
- time Frame
- From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
- title
- Radiographic Progression-Free Survival (rPFS) in Participants With Presence and Absence of Biomarker
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice
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