Trial · NCT01193244
Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
NCT01193244, Phase 3, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2017-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer. Trials, record NCT01193244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01193244
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
- NCT number
- NCT01193244
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,560 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Prostate Cancer
- Interventions
- Orteronel, Placebo, Prednisone
- First posted
- 2010-09-01
- Last updated
- 2017-05-17
- Other registries' IDs
- eudract:2010-018661-35
- Results first posted
- 2017-05-17
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiographic Progression-free Survival (rPFS) | Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years) | rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment. |
| Primary | Overall Survival | Baseline until death (up to 4.7 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 | Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12 | Week 12 | The PSA50 is defined as a decline of at least 50 percent (%) from baseline. |
| Secondary | Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12 | Week 12 | A favorable CTC count was defined as less than \<5 counts per 7.5 milliliter (mL) in whole blood. An unfavorable CTC count was defined as greater than or equal to (\>=) 5 counts/7.5 mL in whole blood. |
| Secondary | Time to Pain Progression | Baseline until End of treatment (EOT) (approximately up to 4.7 years) | Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression 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: The brief pain inventory-short form (BPI-SF) worst pain score was \>=4 with a \>=2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was \>=4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was \<=3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 100 with lower scores being indicative of less pain or pain interference. |
| Secondary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | |
| Secondary | Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3 | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. |
| Secondary | Number of Participants With TEAEs Related to Vital Signs | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | |
| Secondary | Number of Participants With TEAEs Related to Weight | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | |
| Secondary | Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status | Baseline until EOT (approximately up to 4.7 years) | 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 percent 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 percent 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Radiographic Progression-free Survival (rPFS) | Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years) | ITT population included all participants who were randomized. | months | MEDIAN |
| PRIMARY | Overall Survival | Baseline until death (up to 4.7 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 Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12 | Week 12 | ITT population included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Time to Pain Progression | Baseline until End of treatment (EOT) (approximately up to 4.7 years) | ITT population included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3 | Baseline up to 30 days after last dose of study drug (Cycle 61 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 61 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 61 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 until EOT (approximately up to 4.7 years) | 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 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Radiographic Progression-free Survival (rPFS) | Placebo + Prednisone 5 mg | 8.7 | 95% Confidence Interval 8.32 to 10.91 | months | |
| Radiographic Progression-free Survival (rPFS) | Orteronel 400 mg + Prednisone 5 mg | 13.8 | 95% Confidence Interval 13.05 to 14.92 | months | |
| Overall Survival | Placebo + Prednisone 5 mg | 29.5 | 95% Confidence Interval 27.28 to 32.38 | months | |
| Overall Survival | Orteronel 400 mg + Prednisone 5 mg | 29.9 | 95% Confidence Interval 27.88 to 33.04 | months | |
| Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12 | Placebo + Prednisone 5 mg | 24.6 | 95% Confidence Interval 21.7 to 27.8 | percentage of participants | |
| Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12 | Orteronel 400 mg + Prednisone 5 mg | 42.6 | 95% Confidence Interval 39.1 to 46.2 | percentage of participants | |
| Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12 | Placebo + Prednisone 5 mg | 9.1 | 95% Confidence Interval 7.2 to 11.4 | percentage of participants | |
| Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12 | Orteronel 400 mg + Prednisone 5 mg | 15.4 | 95% Confidence Interval 12.9 to 18.1 | percentage of participants | |
| Time to Pain Progression | Placebo + Prednisone 5 mg | NA | 95% Confidence Interval NA to NA | months | |
| Time to Pain Progression | Orteronel 400 mg + Prednisone 5 mg | NA | 95% Confidence Interval 28.57 to NA | months |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 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 5 mg | 779 | |
| Overall Study | STARTED | Orteronel 400 mg + Prednisone 5 mg | 781 | |
| Overall Study | Treated | Placebo + Prednisone 5 mg | 770 | |
| Overall Study | Treated | Orteronel 400 mg + Prednisone 5 mg | 784 | |
| Overall Study | COMPLETED | Placebo + Prednisone 5 mg | 391 | |
| Overall Study | COMPLETED | Orteronel 400 mg + Prednisone 5 mg | 391 | |
| Overall Study | NOT COMPLETED | Placebo + Prednisone 5 mg | 388 | |
| Overall Study | NOT COMPLETED | Orteronel 400 mg + Prednisone 5 mg | 390 |
Source ClinicalTrials.gov
Adverse events914
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 5 mg | 90 | 770 | |
| other | Anaemia | Blood and lymphatic system disorders | Orteronel 400 mg + Prednisone 5 mg | 75 | 784 | |
| other | Nausea | Gastrointestinal disorders | Placebo + Prednisone 5 mg | 130 | 770 | |
| other | Nausea | Gastrointestinal disorders | Orteronel 400 mg + Prednisone 5 mg | 281 | 784 | |
| other | Constipation | Gastrointestinal disorders | Placebo + Prednisone 5 mg | 129 | 770 | |
| other | Constipation | Gastrointestinal disorders | Orteronel 400 mg + Prednisone 5 mg | 261 | 784 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Prednisone 5 mg | 110 | 770 | |
| other | Diarrhoea | Gastrointestinal disorders | Orteronel 400 mg + Prednisone 5 mg | 221 | 784 | |
| other | Vomiting | Gastrointestinal disorders | Placebo + Prednisone 5 mg | 115 | 770 | |
| other | Vomiting | Gastrointestinal disorders | Orteronel 400 mg + Prednisone 5 mg | 174 | 784 |
1 to 10 of 914Source ClinicalTrials.gov
See all 914 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Prednisone 5 mg | ||
| Total, all-cause mortality | Orteronel 400 mg + Prednisone 5 mg | ||
| Total, other adverse events | Placebo + Prednisone 5 mg | 721 | 770 |
| Total, other adverse events | Orteronel 400 mg + Prednisone 5 mg | 757 | 784 |
| Total, serious adverse events | Placebo + Prednisone 5 mg | 321 | 770 |
| Total, serious adverse events | Orteronel 400 mg + Prednisone 5 mg | 380 | 784 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo + Prednisone 5 mg vs Orteronel 400 mg + Prednisone 5 mg: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings | Trial comparisons |
| Placebo + Prednisone 5 mg vs Orteronel 400 mg + Prednisone 5 mg: 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/NCT01193244
GET https://conductscience.org/api/trials/v1/NCT01193244/registered?page=2