Trial · NCT02257736
An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT02257736, Phase 3, Active not recruiting, Aragon Pharmaceuticals, Inc.; results first posted 2021-08-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC). Trials, record NCT02257736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02257736
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
- NCT number
- NCT02257736
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 982 participants, actual
- Lead sponsor
- Aragon Pharmaceuticals, Inc.
- Conditions
- Prostatic Neoplasms
- Interventions
- Apalutamide, Abiraterone acetate, Prednisone, Placebo
- First posted
- 2014-10-06
- Last updated
- 2026-11-04
- Other registries' IDs
- eudract:2014-001718-25
- Results first posted
- 2021-08-16
- Limitations and caveats
This study used an electronic handheld device to collect responses for patient-reported outcome (PRO) questionnaires, which might have resulted in a lower-than-expected compliance due to unfamiliarity of the elderly population with the device.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiographic Progression-free Survival (rPFS) | Up to 3 years and 4 months | The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. |
| Secondary | Overall Survival (OS) | Up to 5 years and 10 months | The OS was defined as the time from randomization to date of death from any cause. |
| Secondary | Time to Chronic Opioid Use | Up to 5 years and 10 months | Time to chronic opioid use was defined as the time from date of randomization to the first date of opioid use. |
| Secondary | Time to Initiation of Cytotoxic Chemotherapy | Up to 5 years and 10 months | Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy. |
| Secondary | Time to Pain Progression | Up to 5 years and 10 months | Time to pain progression: time from randomization to first date that participant either experienced an increase by 2 points from baseline in Brief Pain Inventory Short Form (BPI-SF) worst pain intensity item (item 3) or Case Report Form (CRF) pain, observed at 2 consecutive evaluations \>=4 wks apart, or initiation of chronic opioids as defined in time to chronic opioid use, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3(worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.CRF pain refers to participant's response to global pain assessment "How would you rate your pain over the past 7 days?"with a scale of 0("No pain") to 10("Pain as bad as you can imagine"),that is systematically reported and recorded on the eCRF. |
Source ClinicalTrials.gov
Outcomes5
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) | Up to 3 years and 4 months | Intent-to-treat (ITT) population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 5 years and 10 months | ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received. | months | MEDIAN |
| SECONDARY | Time to Chronic Opioid Use | Up to 5 years and 10 months | ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received. | months | MEDIAN |
| SECONDARY | Time to Initiation of Cytotoxic Chemotherapy | Up to 5 years and 10 months | ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received. | months | MEDIAN |
| SECONDARY | Time to Pain Progression | Up to 5 years and 10 months | ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
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+ Abiraterone Acetate - Prednisolone | 16.59 | 95% Confidence Interval 13.86 to 19.32 | months | |
| Radiographic Progression-free Survival (rPFS) | Apalutamide + Abiraterone Acetate - Prednisolone | 23.98 | 95% Confidence Interval 19.71 to 27.50 | months | |
| Overall Survival (OS) | Placebo+ Abiraterone Acetate - Prednisolone | 33.71 | 95% Confidence Interval 31.24 to 38.28 | months | |
| Overall Survival (OS) | Apalutamide + Abiraterone Acetate - Prednisolone | 36.17 | 95% Confidence Interval 32.76 to 38.77 | months | |
| Time to Chronic Opioid Use | Placebo+ Abiraterone Acetate - Prednisolone | 53.26 | 95% Confidence Interval 42.02 to NA | months | |
| Time to Chronic Opioid Use | Apalutamide + Abiraterone Acetate - Prednisolone | 46.98 | 95% Confidence Interval 39.23 to NA | months | |
| Time to Initiation of Cytotoxic Chemotherapy | Placebo+ Abiraterone Acetate - Prednisolone | 34.23 | 95% Confidence Interval 29.54 to 39.16 | months | |
| Time to Initiation of Cytotoxic Chemotherapy | Apalutamide + Abiraterone Acetate - Prednisolone | 36.11 | 95% Confidence Interval 32.23 to 42.55 | months | |
| Time to Pain Progression | Placebo+ Abiraterone Acetate - Prednisolone | 26.51 | 95% Confidence Interval 22.57 to 29.50 | months | |
| Time to Pain Progression | Apalutamide + Abiraterone Acetate - Prednisolone | 21.82 | 95% Confidence Interval 17.97 to 25.66 | months |
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 | Placebo+ Abiraterone Acetate - Prednisolone | 490 | |
| Overall Study | STARTED | Apalutamide + Abiraterone Acetate - Prednisolone | 492 | |
| Overall Study | COMPLETED | Placebo+ Abiraterone Acetate - Prednisolone | 39 | |
| Overall Study | COMPLETED | Apalutamide + Abiraterone Acetate - Prednisolone | 45 | |
| Overall Study | NOT COMPLETED | Placebo+ Abiraterone Acetate - Prednisolone | 451 | |
| Overall Study | NOT COMPLETED | Apalutamide + Abiraterone Acetate - Prednisolone | 447 |
Source ClinicalTrials.gov
Adverse events618
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+ Abiraterone Acetate - Prednisolone | 77 | 489 | |
| other | Anaemia | Blood and lymphatic system disorders | Apalutamide + Abiraterone Acetate - Prednisolone | 70 | 490 | |
| other | Hypothyroidism | Endocrine disorders | Placebo+ Abiraterone Acetate - Prednisolone | 8 | 489 | |
| other | Hypothyroidism | Endocrine disorders | Apalutamide + Abiraterone Acetate - Prednisolone | 27 | 490 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo+ Abiraterone Acetate - Prednisolone | 25 | 489 | |
| other | Abdominal Pain | Gastrointestinal disorders | Apalutamide + Abiraterone Acetate - Prednisolone | 24 | 490 | |
| other | Constipation | Gastrointestinal disorders | Placebo+ Abiraterone Acetate - Prednisolone | 94 | 489 | |
| other | Constipation | Gastrointestinal disorders | Apalutamide + Abiraterone Acetate - Prednisolone | 96 | 490 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo+ Abiraterone Acetate - Prednisolone | 73 | 489 | |
| other | Diarrhoea | Gastrointestinal disorders | Apalutamide + Abiraterone Acetate - Prednisolone | 91 | 490 |
1 to 10 of 618Source ClinicalTrials.gov
See all 618 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo+ Abiraterone Acetate - Prednisolone | 350 | 489 |
| Total, all-cause mortality | Apalutamide + Abiraterone Acetate - Prednisolone | 338 | 490 |
| Total, other adverse events | Placebo+ Abiraterone Acetate - Prednisolone | 459 | 489 |
| Total, other adverse events | Apalutamide + Abiraterone Acetate - Prednisolone | 472 | 490 |
| Total, serious adverse events | Placebo+ Abiraterone Acetate - Prednisolone | 166 | 489 |
| Total, serious adverse events | Apalutamide + Abiraterone Acetate - Prednisolone | 192 | 490 |
Source ClinicalTrials.gov
Papers2
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+ Abiraterone Acetate - Prednisolone vs Apalutamide + Abiraterone Acetate - Prednisolone: deaths from any cause | Trial comparisons |
| Placebo+ Abiraterone Acetate - Prednisolone vs Apalutamide + Abiraterone Acetate - Prednisolone: 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/NCT02257736
GET https://conductscience.org/api/trials/v1/NCT02257736/events?page=2