Trial · NCT00110214
Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
NCT00110214, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2013-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy. Trials, record NCT00110214. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00110214
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
- NCT number
- NCT00110214
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,050 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- Interventions
- docetaxel, placebo, prednisone, bevacizumab, laboratory biomarker analysis
- First posted
- 2005-05-05
- Last updated
- 2014-05-09
- Results first posted
- 2013-04-17
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 | Duration of study (up to 5 years) | Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method. |
| Secondary | Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline | Duration of study (up to 5 years) | PSA decline will be reported on all patients and will be defined as a decrease in PSA value by \>= 50% for two successive evaluations at least 4 weeks apart. The reference PSA value for these declines should be measured within 2 weeks before starting therapy. |
| Secondary | Progression-free Survival (PFS) | Duration of study (up to 5 years) | PFS was defined as the data of randomization to date of progression or death due to any cause, whichever occurs first. PFS was estimated using the Kaplan Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities | During treatment (up to 2 years) | The National Cancer Institute (NCI) Criteria for Adverse Events(CTCAE) Version 3.0 was used to evaluate toxicity. These events were considered at least possibly related to treatment. Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death |
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 | Duration of study (up to 5 years) | months | MEDIAN | |
| SECONDARY | Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline | Duration of study (up to 5 years) | percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) | Duration of study (up to 5 years) | months | MEDIAN | |
| SECONDARY | Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities | During treatment (up to 2 years) | Participants who did not received allocated intervention were excluded from toxicity analysis. | percentage of participants | NUMBER |
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 | Docetaxel + Placebo | 21.5 | 95% Confidence Interval 20.0 to 23.0 | months | |
| Overall Survival | Docetaxel + Bevacizumab | 22.6 | 95% Confidence Interval 21.1 to 24.5 | months | |
| Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline | Docetaxel + Placebo | 57.9 | percentage of participants | ||
| Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline | Docetaxel + Bevacizumab | 69.5 | percentage of participants | ||
| Progression-free Survival (PFS) | Docetaxel + Placebo | 7.5 | 95% Confidence Interval 6.8 to 8.0 | months | |
| Progression-free Survival (PFS) | Docetaxel + Bevacizumab | 9.9 | 95% Confidence Interval 9.0 to 10.6 | months | |
| Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities | Docetaxel + Placebo | 56.2 | percentage of participants | ||
| Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities | Docetaxel + Bevacizumab | 75.4 | percentage of participants |
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 | Docetaxel + Placebo | 526 | |
| Overall Study | STARTED | Docetaxel + Bevacizumab | 524 | |
| Overall Study | COMPLETED | Docetaxel + Placebo | 17 | |
| Overall Study | COMPLETED | Docetaxel + Bevacizumab | 21 | |
| Overall Study | NOT COMPLETED | Docetaxel + Placebo | 509 | |
| Overall Study | NOT COMPLETED | Docetaxel + Bevacizumab | 503 |
Source ClinicalTrials.gov
Adverse events574
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 | Febrile neutropenia | Blood and lymphatic system disorders | Docetaxel + Placebo | 15 | 505 | 15 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Docetaxel + Bevacizumab | 5 | 504 | 5 |
| other | Hemoglobin | Blood and lymphatic system disorders | Docetaxel + Placebo | 12 | 505 | 20 |
| other | Hemoglobin | Blood and lymphatic system disorders | Docetaxel + Bevacizumab | 9 | 504 | 11 |
| other | Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis) | Blood and lymphatic system disorders | Docetaxel + Placebo | 0 | 505 | 0 |
| other | Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis) | Blood and lymphatic system disorders | Docetaxel + Bevacizumab | 2 | 504 | 2 |
| other | Lymphatics - Other | Blood and lymphatic system disorders | Docetaxel + Placebo | 0 | 505 | 0 |
| other | Lymphatics - Other | Blood and lymphatic system disorders | Docetaxel + Bevacizumab | 2 | 504 | 2 |
| other | Cardiac Arrhythmia - Other | Cardiac disorders | Docetaxel + Placebo | 1 | 505 | 1 |
| other | Cardiac Arrhythmia - Other | Cardiac disorders | Docetaxel + Bevacizumab | 0 | 504 | 0 |
1 to 10 of 574Source ClinicalTrials.gov
See all 574 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Docetaxel + Placebo | ||
| Total, all-cause mortality | Docetaxel + Bevacizumab | ||
| Total, other adverse events | Docetaxel + Placebo | 420 | 505 |
| Total, other adverse events | Docetaxel + Bevacizumab | 363 | 504 |
| Total, serious adverse events | Docetaxel + Placebo | 237 | 505 |
| Total, serious adverse events | Docetaxel + Bevacizumab | 178 | 504 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA014236 | Cancer Center Support Grant (CCSG) | KASTAN, MICHAEL B | DUKE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Docetaxel + Placebo vs Docetaxel + Bevacizumab: 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/NCT00110214
GET https://conductscience.org/api/trials/v1/NCT00110214/events?page=2