Trial · NCT00638690
Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
NCT00638690, Phase 3, Completed, Cougar Biotechnology, Inc.; results first posted 2013-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy. Trials, record NCT00638690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00638690
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
- NCT number
- NCT00638690
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,195 participants, actual
- Lead sponsor
- Cougar Biotechnology, Inc.
- Conditions
- Prostatic Neoplasms
- Interventions
- Placebo, Abiraterone acetate, Prednisone/prednisolone
- First posted
- 2008-03-19
- Last updated
- 2014-04-30
- Results first posted
- 2013-05-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Up to 60 months | Overall survival is defined as the time interval from the date of randomization to the date of death from any cause. |
| Secondary | Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria | Up to 12 months | The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart. |
| Secondary | Number of Patients Achieving a Prostate-Specific Antigen Decline >=50% | Up to 12 months | A prostate-specific antigen (PSA) response was defined as a \>=50% decline from baseline. |
| Secondary | Radiographic Progression-free Survival | Up to 11 months | Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be \>=2.0 cm to be considered a target lesion; progression on bone scans with \>=2 new lesions not consistent with tumor flare, confirmed on a second scan \>=6 weeks later that shows \>=1 additional new lesion. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Up to 60 months | Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received. | Days | MEDIAN |
| SECONDARY | Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria | Up to 12 months | Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received. | Days | MEDIAN |
| SECONDARY | Number of Patients Achieving a Prostate-Specific Antigen Decline >=50% | Up to 12 months | Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received. | Participants | NUMBER |
| SECONDARY | Radiographic Progression-free Survival | Up to 11 months | Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Abiraterone Acetate | 450.0 | 95% Confidence Interval 430.0 to 470.0 | Days | |
| Overall Survival | Placebo | 332.0 | 95% Confidence Interval 310.0 to 366.0 | Days | |
| Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria | Abiraterone Acetate | 309.0 | 95% Confidence Interval 255.0 to 421.0 | Days | |
| Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria | Placebo | 200.0 | 95% Confidence Interval 170.0 to 254.0 | Days | |
| Number of Patients Achieving a Prostate-Specific Antigen Decline >=50% | Abiraterone Acetate | 232 | Participants | ||
| Number of Patients Achieving a Prostate-Specific Antigen Decline >=50% | Placebo | 22 | Participants | ||
| Radiographic Progression-free Survival | Abiraterone Acetate | 171.0 | 95% Confidence Interval 169.0 to 192.0 | Days | |
| Radiographic Progression-free Survival | Placebo | 110.0 | 95% Confidence Interval 88.0 to 168.0 | Days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abiraterone Acetate | 797 | |
| Overall Study | STARTED | Placebo | 398 | |
| Overall Study | COMPLETED | Abiraterone Acetate | 116 | |
| Overall Study | COMPLETED | Placebo | 56 | |
| Overall Study | NOT COMPLETED | Abiraterone Acetate | 681 | |
| Overall Study | NOT COMPLETED | Placebo | 342 |
Source ClinicalTrials.gov
Adverse events1,143
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 | Anaemia | Blood and lymphatic system disorders | Abiraterone Acetate | 202 | 791 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 105 | 394 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo to Abiraterone Acetate | 11 | 67 | |
| other | Constipation | Gastrointestinal disorders | Abiraterone Acetate | 236 | 791 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 124 | 394 | |
| other | Constipation | Gastrointestinal disorders | Placebo to Abiraterone Acetate | 14 | 67 | |
| other | Diarrhoea | Gastrointestinal disorders | Abiraterone Acetate | 166 | 791 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 57 | 394 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo to Abiraterone Acetate | 13 | 67 | |
| other | Dyspepsia | Gastrointestinal disorders | Abiraterone Acetate | 54 | 791 |
1 to 10 of 1,143Source ClinicalTrials.gov
See all 1,143 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abiraterone Acetate | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Placebo to Abiraterone Acetate | ||
| Total, other adverse events | Abiraterone Acetate | 766 | 791 |
| Total, other adverse events | Placebo | 381 | 394 |
| Total, other adverse events | Placebo to Abiraterone Acetate | 57 | 67 |
| Total, serious adverse events | Abiraterone Acetate | 365 | 791 |
| Total, serious adverse events | Placebo | 175 | 394 |
| Total, serious adverse events | Placebo to Abiraterone Acetate | 29 | 67 |
Source ClinicalTrials.gov
Papers13
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 |
|---|
| Abiraterone Acetate vs Placebo: Number of Patients Achieving a Prostate-Specific Antigen Decline >=50% |
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/NCT00638690
GET https://conductscience.org/api/trials/v1/NCT00638690/events?page=2