Trial · NCT01949337
Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer
NCT01949337, Phase 3, Unknown, Alliance for Clinical Trials in Oncology; results first posted 2020-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer. Trials, record NCT01949337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01949337
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer
- NCT number
- NCT01949337
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 1,311 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- Interventions
- enzalutamide, abiraterone, prednisone
- First posted
- 2013-09-24
- Last updated
- 2023-09-28
- Results first posted
- 2020-06-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 5 years post treatment | Overall survival is defined as the time from study registration to death due to any cause. |
| Secondary | Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment) | Up to 5 years post treatment | The number of participants who has experienced at least one toxicity (defined as a grade 3 or higher adverse event deemed at least possibly related to treatment) |
| Secondary | Decline in Prostate Specific Antigen (PSA) | Up to 5 years post treatment | |
| Secondary | Progression Free Survival (PFS) | Up to 5 years post treatment | |
| Secondary | Objective Response Rate | Up to 5 years post treatment | |
| Secondary | Radiographic Progression Free Survival (rPFS) | Up to 5 years post treatment | |
| Secondary | Tumor Burden and Bone Activity | Up to 5 years post treatment |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to 5 years post treatment | months | MEDIAN | |
| SECONDARY | Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment) | Up to 5 years post treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Decline in Prostate Specific Antigen (PSA) | Up to 5 years post treatment | |||
| SECONDARY | Progression Free Survival (PFS) | Up to 5 years post treatment | |||
| SECONDARY | Objective Response Rate | Up to 5 years post treatment | |||
| SECONDARY | Radiographic Progression Free Survival (rPFS) | Up to 5 years post treatment | |||
| SECONDARY | Tumor Burden and Bone Activity | Up to 5 years post treatment |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Arm A: (Enzalutamide) | 32.5 | 95% Confidence Interval 30.4 to 35.4 | months | |
| Overall Survival (OS) | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 34.2 | 95% Confidence Interval 31.8 to 37.5 | months | |
| Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment) | Arm A: (Enzalutamide) | 167 | Participants | ||
| Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment) | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 287 | 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 | Arm A: (Enzalutamide) | 657 | |
| Overall Study | STARTED | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 654 | |
| Overall Study | COMPLETED | Arm A: (Enzalutamide) | 657 | |
| Overall Study | COMPLETED | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 654 | |
| Overall Study | NOT COMPLETED | Arm A: (Enzalutamide) | 0 | |
| Overall Study | NOT COMPLETED | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 0 |
Source ClinicalTrials.gov
Adverse events1,080
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 | Anemia | Blood and lymphatic system disorders | Arm A: (Enzalutamide) | 188 | 657 | 1,185 |
| other | Anemia | Blood and lymphatic system disorders | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 170 | 654 | 1,064 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Arm A: (Enzalutamide) | 5 | 657 | 10 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 9 | 654 | 38 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm A: (Enzalutamide) | 1 | 657 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 0 | 654 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm A: (Enzalutamide) | 0 | 657 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 1 | 654 | 1 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm A: (Enzalutamide) | 1 | 657 | 2 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 1 | 654 | 2 |
1 to 10 of 1,080Source ClinicalTrials.gov
See all 1,080 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: (Enzalutamide) | 372 | 657 |
| Total, all-cause mortality | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 339 | 654 |
| Total, other adverse events | Arm A: (Enzalutamide) | 645 | 657 |
| Total, other adverse events | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 627 | 654 |
| Total, serious adverse events | Arm A: (Enzalutamide) | 232 | 657 |
| Total, serious adverse events | Arm B: (Enzalutamide, Abiraterone, Prednisone) | 269 | 654 |
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 |
|---|---|---|---|---|---|
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Arm A: (Enzalutamide) vs Arm B: (Enzalutamide, Abiraterone, Prednisone): Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment) | Trial comparisons |
| Arm A: (Enzalutamide) vs Arm B: (Enzalutamide, Abiraterone, Prednisone): deaths from any cause | Trial comparisons |
| Arm A: (Enzalutamide) vs Arm B: (Enzalutamide, Abiraterone, 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/NCT01949337
GET https://conductscience.org/api/trials/v1/NCT01949337/events?page=2