Trial · NCT01193257
Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
NCT01193257, Phase 3, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2018-12-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer. Trials, record NCT01193257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01193257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
- NCT number
- NCT01193257
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,099 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Prostate Cancer
- Interventions
- Orteronel, Prednisone, Orteronel Placebo
- First posted
- 2010-09-01
- Last updated
- 2018-12-19
- Other registries' IDs
- eudract:2010-018662-23
- Results first posted
- 2018-12-19
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Baseline until death (approximately up to 4.5 years) | Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier. |
| Secondary | Radiographic Progression-free Survival (rPFS) | Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years) | rPFS was defined as the time from randomization until radiographic disease progression or death due to any cause, whichever occurred first. Radiographic disease progression was defined as the occurrence of 1 or more of the following: The appearance of 2 or more new lesions on radionuclide bone scan as defined by prostate cancer working group (PCWG)2; Should 2 or more new bone lesions be evident at the first assessment (8-week assessment) on treatment, 2 or more additional new lesions must have been evident on a confirmatory assessment at least 6 weeks later; One or more new soft tissue/visceral organ lesions identified by computed tomography (CT)/magnetic resonance imaging (MRI); Progression as defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria. |
| Secondary | Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12 | Week 12 | The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline. |
| Secondary | Percentage of Participants With Pain Response at Week 12 | Week 12 | Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A greater than or equal to (\>=) 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use; or a 25 percent (%) or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. |
| Secondary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | |
| Secondary | Number of Participants With Abnormal Physical Examination Findings | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | |
| Secondary | Number of Participants With TEAEs Related to Vital Signs | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | |
| Secondary | Number of Participants With TEAEs Related to Weight | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | |
| Secondary | Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status | Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58) | ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours \[hrs\]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period. |
| Secondary | Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings | Cycle 59 Day 58 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Baseline until death (approximately up to 4.5 years) | ITT population included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Radiographic Progression-free Survival (rPFS) | Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years) | ITT population included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12 | Week 12 | ITT population included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain Response at Week 12 | Week 12 | ITT population included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Physical Examination Findings | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With TEAEs Related to Vital Signs | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With TEAEs Related to Weight | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status | Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58) | Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings | Cycle 59 Day 58 | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Placebo + Prednisone | 15.3 | 95% Confidence Interval 13.48 to 16.86 | months | |
| Overall Survival | Orteronel + Prednisone | 17.1 | 95% Confidence Interval 15.45 to 18.67 | months | |
| Radiographic Progression-free Survival (rPFS) | Placebo + Prednisone | 5.7 | 95% Confidence Interval 5.46 to 6.97 | months | |
| Radiographic Progression-free Survival (rPFS) | Orteronel + Prednisone | 8.3 | 95% Confidence Interval 7.76 to 8.48 | months | |
| Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12 | Placebo + Prednisone | 9.9 | percentage of participants | ||
| Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12 | Orteronel + Prednisone | 24.9 | percentage of participants | ||
| Percentage of Participants With Pain Response at Week 12 | Placebo + Prednisone | 9.0 | percentage of participants | ||
| Percentage of Participants With Pain Response at Week 12 | Orteronel + Prednisone | 12.1 | percentage of participants | ||
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Placebo + Prednisone | 345 | participants | ||
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Orteronel + Prednisone | 719 | participants |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Prednisone | 365 | |
| Overall Study | STARTED | Orteronel + Prednisone | 734 | |
| Overall Study | Treated | Placebo + Prednisone | 363 | |
| Overall Study | Treated | Orteronel + Prednisone | 732 | |
| Overall Study | COMPLETED | Placebo + Prednisone | 0 | |
| Overall Study | COMPLETED | Orteronel + Prednisone | 0 | |
| Overall Study | NOT COMPLETED | Placebo + Prednisone | 365 | |
| Overall Study | NOT COMPLETED | Orteronel + Prednisone | 734 |
Source ClinicalTrials.gov
Adverse events742
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 | Placebo + Prednisone | 59 | 363 | |
| other | Anaemia | Blood and lymphatic system disorders | Orteronel + Prednisone | 103 | 732 | |
| other | Nausea | Gastrointestinal disorders | Placebo + Prednisone | 94 | 363 | |
| other | Nausea | Gastrointestinal disorders | Orteronel + Prednisone | 319 | 732 | |
| other | Vomiting | Gastrointestinal disorders | Placebo + Prednisone | 60 | 363 | |
| other | Vomiting | Gastrointestinal disorders | Orteronel + Prednisone | 272 | 732 | |
| other | Constipation | Gastrointestinal disorders | Placebo + Prednisone | 64 | 363 | |
| other | Constipation | Gastrointestinal disorders | Orteronel + Prednisone | 222 | 732 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Prednisone | 54 | 363 | |
| other | Diarrhoea | Gastrointestinal disorders | Orteronel + Prednisone | 201 | 732 |
1 to 10 of 742Source ClinicalTrials.gov
See all 742 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Prednisone | ||
| Total, all-cause mortality | Orteronel + Prednisone | ||
| Total, other adverse events | Placebo + Prednisone | 341 | 363 |
| Total, other adverse events | Orteronel + Prednisone | 703 | 732 |
| Total, serious adverse events | Placebo + Prednisone | 148 | 363 |
| Total, serious adverse events | Orteronel + Prednisone | 384 | 732 |
Source ClinicalTrials.gov
Papers3
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo + Prednisone vs Orteronel + Prednisone: Number of Participants With Abnormal Physical Examination Findings | Trial comparisons |
| Placebo + Prednisone vs Orteronel + Prednisone: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings | Trial comparisons |
| Placebo + Prednisone vs Orteronel + Prednisone: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Placebo + Prednisone vs Orteronel + Prednisone: Number of Participants With Best Pain Response | Trial comparisons |
| Placebo + Prednisone vs Orteronel + Prednisone: 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/NCT01193257
GET https://conductscience.org/api/trials/v1/NCT01193257/registered?page=2