Trial · NCT01308580
Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer
NCT01308580, Phase 3, Completed, Sanofi; results first posted 2016-10-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer. Trials, record NCT01308580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01308580
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer
- NCT number
- NCT01308580
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,200 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Prostate Cancer
- Interventions
- Cabazitaxel (XRP6258), Prednisone (or Prednisolone)
- First posted
- 2011-03-04
- Last updated
- 2017-04-17
- Other registries' IDs
- eudract:2010-022163-35
- Results first posted
- 2016-10-11
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method. |
| Secondary | Progression Free Survival (PFS) | From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA \>0 ng/mL \& \<10 ng/mL; or post-baseline value of \>=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method. |
| Secondary | Time to Tumor Progression | From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method. |
| Secondary | Percentage of Participants With Overall Objective Tumor Response | From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Time to PSA Progression | From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Time to PSA progression was time interval between randomization \& first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (\>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve \>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA \<10 ng/mL): (a) participants with baseline PSA \>0 ng/mL \& \<10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method. |
| Secondary | Percentage of Participants With PSA Response | From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL. |
| Secondary | Time to Pain Progression | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) | Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method. |
| Secondary | Percentage of Participants With Pain Response | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) | Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response. |
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL) | Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks) | FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL. |
| Secondary | Change From Baseline in FACT-P:Total Score as a Measure of HRQoL | Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks) | FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Time to Tumor Progression | From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Overall Objective Tumor Response | From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for tumor response with measurable disease at baseline and at least one valid post-baseline value. | percentage of participants | NUMBER |
| SECONDARY | Time to PSA Progression | From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With PSA Response | From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for PSA response with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value. | percentage of participants | NUMBER |
| SECONDARY | Time to Pain Progression | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Pain Response | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) | Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for pain response with pain score with median PPI ≥2 and/or mean AS ≥10 points at baseline and at least one valid post-baseline value. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL) | Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks) | FACT-P population included randomized participants who completed FACT-P questionnaire at baseline \& in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FACT-P:Total Score as a Measure of HRQoL | Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks) | Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Cabazitaxel 20 mg/m^2 | 13.4 | 95% Confidence Interval 12.19 to 14.88 | months | |
| Overall Survival (OS) | Cabazitaxel 25 mg/m^2 | 14.5 | 95% Confidence Interval 13.47 to 15.28 | months | |
| Progression Free Survival (PFS) | Cabazitaxel 20 mg/m^2 | 2.9 | 95% Confidence Interval 2.79 to 3.45 | months | |
| Progression Free Survival (PFS) | Cabazitaxel 25 mg/m^2 | 3.5 | 95% Confidence Interval 3.12 to 3.94 | months | |
| Time to Tumor Progression | Cabazitaxel 20 mg/m^2 | 9.0 | 95% Confidence Interval 8.38 to 9.79 | months | |
| Time to Tumor Progression | Cabazitaxel 25 mg/m^2 | 9.3 | 95% Confidence Interval 8.61 to 9.92 | months | |
| Percentage of Participants With Overall Objective Tumor Response | Cabazitaxel 20 mg/m^2 | 18.5 | 95% Confidence Interval 13.8 to 23.1 | percentage of participants | |
| Percentage of Participants With Overall Objective Tumor Response | Cabazitaxel 25 mg/m^2 | 23.4 | 95% Confidence Interval 18.2 to 28.6 | percentage of participants | |
| Time to PSA Progression | Cabazitaxel 20 mg/m^2 | 5.7 | 95% Confidence Interval 4.96 to 6.47 | months | |
| Time to PSA Progression | Cabazitaxel 25 mg/m^2 | 6.8 | 95% Confidence Interval 6.11 to 7.46 | months |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cabazitaxel 20 mg/m^2 | 598 | |
| Overall Study | STARTED | Cabazitaxel 25 mg/m^2 | 602 | |
| Overall Study | Treated | Cabazitaxel 20 mg/m^2 | 587 | |
| Overall Study | Treated | Cabazitaxel 25 mg/m^2 | 588 | |
| Overall Study | COMPLETED | Cabazitaxel 20 mg/m^2 | 586 | |
| Overall Study | COMPLETED | Cabazitaxel 25 mg/m^2 | 595 | |
| Overall Study | NOT COMPLETED | Cabazitaxel 20 mg/m^2 | 12 | |
| Overall Study | NOT COMPLETED | Cabazitaxel 25 mg/m^2 | 7 |
Source ClinicalTrials.gov
Adverse events488
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary tract infection | Infections and infestations | Cabazitaxel 20 mg/m^2 | 33 | 580 | |
| other | Urinary tract infection | Infections and infestations | Cabazitaxel 25 mg/m^2 | 51 | 595 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cabazitaxel 20 mg/m^2 | 15 | 580 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cabazitaxel 25 mg/m^2 | 40 | 595 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Cabazitaxel 20 mg/m^2 | 74 | 580 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Cabazitaxel 25 mg/m^2 | 108 | 595 | |
| other | Dizziness | Nervous system disorders | Cabazitaxel 20 mg/m^2 | 24 | 580 | |
| other | Dizziness | Nervous system disorders | Cabazitaxel 25 mg/m^2 | 32 | 595 | |
| other | Dysgeusia | Nervous system disorders | Cabazitaxel 20 mg/m^2 | 41 | 580 | |
| other | Dysgeusia | Nervous system disorders | Cabazitaxel 25 mg/m^2 | 63 | 595 |
1 to 10 of 488Source ClinicalTrials.gov
See all 488 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cabazitaxel 20 mg/m^2 | ||
| Total, all-cause mortality | Cabazitaxel 25 mg/m^2 | ||
| Total, other adverse events | Cabazitaxel 20 mg/m^2 | 450 | 580 |
| Total, other adverse events | Cabazitaxel 25 mg/m^2 | 507 | 595 |
| Total, serious adverse events | Cabazitaxel 20 mg/m^2 | 177 | 580 |
| Total, serious adverse events | Cabazitaxel 25 mg/m^2 | 257 | 595 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cabazitaxel 20 mg/m^2 vs Cabazitaxel 25 mg/m^2: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01308580
GET https://conductscience.org/api/trials/v1/NCT01308580/results?page=2