Trial · NCT00134056
S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy
NCT00134056, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2017-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy. Trials, record NCT00134056. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00134056
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy
- NCT number
- NCT00134056
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,038 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Metastatic Cancer, Prostate Cancer
- Interventions
- atrasentan hydrochloride, docetaxel, prednisone, placebo
- First posted
- 2005-08-24
- Last updated
- 2021-10-27
- Results first posted
- 2017-05-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. | Up to 7 years after study opens | Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact. |
| Primary | Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. | Up to 7 years after study opens | Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients without progression are censored at date of last contact. Disease progression is defined by confirmed bone disease progression, soft tissue or pain progression. |
| Secondary | Compare Pain Progression Between the Two Study Arms. | Up to 52 weeks | Pain progression is defined as patients reporting an increase of at least two Worst Pain points, maintained for at least two consecutive assessments, increase to Level 3 (strong opioid) on the Pain Medication Log Analgesic Code for patients receiving Level 2 (weak opioid) analgesics at randomization, or an increase to Level 2 or 3 analgesics for patients receiving Level 0 or 1 analgesics at randomization. |
| Secondary | Compare Qualitative and Quantitative Toxicity Between the Two Study Arms | Assessed every 3 weeks up to 52 weeks | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Secondary | Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm. | Up to 7 years after study opens | PSA Partial Response: Greater than or equal to 50% reduction in baseline PSA. There must be no evidence of soft tissue progression, or confirmed none disease progression, or pain progression. |
| Secondary | Compare Objective Responses Between the Two Treatment Groups in Patients With Measurable Disease as Defined by RECIST Criteria. | Up to 52 weeks | Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. PSA ≤ .2 ng/ml. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. |
| Other | Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI) | up to 18 months study period | Pain palliation is the proportion of patients showing a two-point reduction in the Worst Pain score (WPS) maintained for two consecutive assessments with no increase in analgesic use. Increase in analgesic use is defined as an increase in Analgesic code Level to 2 (weak opioid) or 3 (strong opioid). Patients will be classified as pain palliated or not palliated. Patients with a WPS of "0" will be defined as "stable" if their WPS remains "0" for Weeks 7 and 10 with no increase in analgesic use, but they will not be categorized as responders. Pain palliation response is measured by BPI short form that has the following: yes/no question about pain today; 4 pain rating questions (worst pain, least pain, average pain, and current pain); pain medications and pain relief; 7 items addressing effect of pain on functioning. For patients who continue to receive treatment beyond 12 treatment cycles, the Worst Pain item is measured by Pain Medication Log and Pain Assessment |
| Other | Number of Patients With a Change in Functional Status | up to 18 months study period | Functional status will be measured with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index. The FACT-P also addresses four general domains of QOL (physical, functional, emotional, and social well-being subscales) as well as symptom concerns associated with prostate cancer and its treatment. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. | Up to 7 years after study opens | months | MEDIAN | |
| PRIMARY | Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. | Up to 7 years after study opens | months | MEDIAN | |
| SECONDARY | Compare Pain Progression Between the Two Study Arms. | Up to 52 weeks | Only those patients who progressed on study were included in this analysis. The proportion of patients with pain progression is calculated using number of patients with pain progression as the numerator and the total number of patients who progressed on study as the denominator. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Compare Qualitative and Quantitative Toxicity Between the Two Study Arms | Assessed every 3 weeks up to 52 weeks | patients with hormone-refractory stage IV prostate cancer and bone metastases treated with docetaxel and prednisone combined with either atrasentan vs placebo | Participants | NUMBER |
| SECONDARY | Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm. | Up to 7 years after study opens | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Compare Objective Responses Between the Two Treatment Groups in Patients With Measurable Disease as Defined by RECIST Criteria. | Up to 52 weeks | 450 (225 in each arm) of 461 patients with measurable disease at trial enrollment were assessable for response by RECIST. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI) | up to 18 months study period | There was a large amount of missing data points due to the difficulty of data collection of pain medication logs in addition to a questionnaire.The study team and site staff were only able to obtain complete data for the patients included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Patients With a Change in Functional Status | up to 18 months study period | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group324
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. | Arm I: Placebo | 17.6 | 95% Confidence Interval 16.4 to 20.1 | months | |
| Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. | Arm II: Atrasentan | 17.8 | 95% Confidence Interval 16.4 to 19.8 | months | |
Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. | Arm I: Placebo | 9.1 | 95% Confidence Interval 8.4 to 10.2 | months | |
Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. | Arm II: Atrasentan | 9.2 | 95% Confidence Interval 8.5 to 9.9 | months | |
| Compare Pain Progression Between the Two Study Arms. | Arm I: Placebo | 59 | Participants | ||
| Compare Pain Progression Between the Two Study Arms. | Arm II: Atrasentan | 41 | Participants | ||
| Compare Qualitative and Quantitative Toxicity Between the Two Study Arms | Arm I: Placebo | ALT, SGPT (serum glutamic pyruvic transaminase) | 2 | Participants | |
| Compare Qualitative and Quantitative Toxicity Between the Two Study Arms | Arm II: Atrasentan | ALT, SGPT (serum glutamic pyruvic transaminase) | 2 | Participants | |
| Compare Qualitative and Quantitative Toxicity Between the Two Study Arms | Arm I: Placebo | AST, SGOT | 2 | Participants | |
| Compare Qualitative and Quantitative Toxicity Between the Two Study Arms | Arm II: Atrasentan | AST, SGOT | 4 | Participants |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization | STARTED | Arm I: Placebo | 518 | |
| Randomization | STARTED | Arm II: Atrasentan | 520 | |
| Randomization | COMPLETED | Arm I: Placebo | 496 | |
| Randomization | COMPLETED | Arm II: Atrasentan | 500 | |
| Randomization | NOT COMPLETED | Arm I: Placebo | 22 | |
| Randomization | NOT COMPLETED | Arm II: Atrasentan | 20 | |
| Eligible for Protocol Assigned Treatment | STARTED | Arm I: Placebo | 496 | |
| Eligible for Protocol Assigned Treatment | STARTED | Arm II: Atrasentan | 500 | |
| Eligible for Protocol Assigned Treatment | COMPLETED | Arm I: Placebo | 169 | |
| Eligible for Protocol Assigned Treatment | COMPLETED | Arm II: Atrasentan | 185 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events498
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 | Hemoglobin | Blood and lymphatic system disorders | Arm I: Placebo | 350 | 486 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm II: Atrasentan | 331 | 492 | |
| other | Vision-blurred vision | Eye disorders | Arm I: Placebo | 26 | 486 | |
| other | Vision-blurred vision | Eye disorders | Arm II: Atrasentan | 14 | 492 | |
| other | Watery eye (epiphora, tearing) | Eye disorders | Arm I: Placebo | 37 | 486 | |
| other | Watery eye (epiphora, tearing) | Eye disorders | Arm II: Atrasentan | 41 | 492 | |
| other | Constipation | Gastrointestinal disorders | Arm I: Placebo | 185 | 486 | |
| other | Constipation | Gastrointestinal disorders | Arm II: Atrasentan | 176 | 492 | |
| other | Diarrhea | Gastrointestinal disorders | Arm I: Placebo | 143 | 486 | |
| other | Diarrhea | Gastrointestinal disorders | Arm II: Atrasentan | 149 | 492 |
1 to 10 of 498Source ClinicalTrials.gov
See all 498 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: Placebo | ||
| Total, all-cause mortality | Arm II: Atrasentan | ||
| Total, other adverse events | Arm I: Placebo | 476 | 486 |
| Total, other adverse events | Arm II: Atrasentan | 475 | 492 |
| Total, serious adverse events | Arm I: Placebo | 172 | 486 |
| Total, serious adverse events | Arm II: Atrasentan | 153 | 492 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm II: Atrasentan vs Arm I: Placebo: Compare Pain Progression Between the Two Study Arms. | Trial comparisons |
| Arm II: Atrasentan Hydrochloride vs Arm I: Placebo: Number of Patients With a Change in Functional Status | Trial comparisons |
| Arm II: Atrasentan vs Arm I: Placebo: Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI) | Trial comparisons |
| Arm II: Atrasentan vs Arm I: Placebo: Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm. | Trial comparisons |
| Arm II: Atrasentan vs Arm I: Placebo: serious adverse events | 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/NCT00134056
GET https://conductscience.org/api/trials/v1/NCT00134056/results?page=2