Trial · NCT05520138
Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT05520138, Completed, Pfizer; results first posted 2024-09-27
3 sourcestrials-2026-11-12-0.4.0
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Cite this record
ConductScience Library. Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC). Trials, record NCT05520138. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05520138
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)
- NCT number
- NCT05520138
- Status
- Completed
- Enrollment
- 5,506 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- Enzalutamide, Abiraterone acetate
- First posted
- 2022-08-29
- Last updated
- 2024-09-27
- Results first posted
- 2024-09-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW) | From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months) | OS (time to death) was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability. Kaplan-Meier method was used for analysis. |
| Secondary | OS Among Participants Without Any Subsequent Therapy: IPTW | From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months) | OS (time to death) was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability. Kaplan-Meier method was used for analysis. |
| Secondary | Treatment Duration: IPTW | From index date to date of discontinuation event or censoring date, whichever occurred first(from 10-Sep-2014 to 31-Dec-2020, approximately 76months); retrospective data extracted and evaluated from start date and until completion(approximately 10months) | Treatment duration of the index treatment was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the discontinuation date. Discontinuation was defined as the earliest of 1) death, 2) last observed administration plus day of supply associated with last administration, or 3) day before the start of next line of therapy. Death, a gap of 90 days or more after the last observed prescription date + day of supply, and initiation of next line of therapy was considered as discontinuation events. Participants who did not discontinue were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability. |
| Secondary | Time to Subsequent Therapy: IPTW | From index date to start of next line of therapy (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months) | Time to subsequent therapy was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the start of next line of therapy. Participants who did not start a new line of therapy were censored at their last available follow-up, which was defined as the earliest of 1) death, 2) disenrollment from Medicare, and 3) end of data availability. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW) | From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months) | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure after adjusting for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities, medical resource use) using IPTW. Hence, numbers are different here from those presented in participant and baseline section. | Months | MEDIAN |
| SECONDARY | OS Among Participants Without Any Subsequent Therapy: IPTW | From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months) | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure after adjusting for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities, medical resource use) using IPTW. Hence, numbers are different here from those presented in participant and baseline section. | Months | MEDIAN |
| SECONDARY | Treatment Duration: IPTW | From index date to date of discontinuation event or censoring date, whichever occurred first(from 10-Sep-2014 to 31-Dec-2020, approximately 76months); retrospective data extracted and evaluated from start date and until completion(approximately 10months) | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure after adjusting for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities, medical resource use) using IPTW. Hence, numbers are different here from those presented in participant and baseline section. | Months | MEDIAN |
| SECONDARY | Time to Subsequent Therapy: IPTW | From index date to start of next line of therapy (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months) | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure after adjusting for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities, medical resource use) using IPTW. Hence, numbers are different here from those presented in participant and baseline section. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW) | Abiraterone | 20.6 | 95% Confidence Interval 19.7 to 21.4 | Months | |
| Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW) | Enzalutamide | 22.5 | 95% Confidence Interval 21.2 to 23.8 | Months | |
| OS Among Participants Without Any Subsequent Therapy: IPTW | Abiraterone | 10.6 | 95% Confidence Interval 9.6 to 11.7 | Months | |
| OS Among Participants Without Any Subsequent Therapy: IPTW | Enzalutamide | 13.6 | 95% Confidence Interval 12.4 to 15.1 | Months | |
| Treatment Duration: IPTW | Abiraterone | 6.7 | 95% Confidence Interval 6.3 to 7.0 | Months | |
| Treatment Duration: IPTW | Enzalutamide | 7.4 | 95% Confidence Interval 7.0 to 7.9 | Months | |
| Time to Subsequent Therapy: IPTW | Abiraterone | 14.5 | 95% Confidence Interval 13.4 to 15.4 | Months | |
| Time to Subsequent Therapy: IPTW | Enzalutamide | 16.7 | 95% Confidence Interval 15.9 to 17.8 | 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 | Abiraterone | 2,911 | |
| Overall Study | STARTED | Enzalutamide | 2,595 | |
| Overall Study | COMPLETED | Abiraterone | 2,911 | |
| Overall Study | COMPLETED | Enzalutamide | 2,595 | |
| Overall Study | NOT COMPLETED | Abiraterone | 0 | |
| Overall Study | NOT COMPLETED | Enzalutamide | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abiraterone | 2,523 | 2,911 |
| Total, all-cause mortality | Enzalutamide | 2,176 | 2,595 |
| Total, other adverse events | Abiraterone | 0 | 0 |
| Total, other adverse events | Enzalutamide | 0 | 0 |
| Total, serious adverse events | Abiraterone | 0 | 0 |
| Total, serious adverse events | Enzalutamide | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Abiraterone vs Enzalutamide: deaths from any cause |
Source 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05520138
GET https://conductscience.org/api/trials/v1/NCT05520138/registered