Trial · NCT05968599
A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
NCT05968599, Completed, Pfizer; results first posted 2026-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer. Trials, record NCT05968599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05968599
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
- NCT number
- NCT05968599
- Status
- Completed
- Enrollment
- 2,731 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- Enzalutamide, Abiraterone acetate
- First posted
- 2023-08-01
- Last updated
- 2026-02-25
- Results first posted
- 2026-02-25
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): Adjusted Using Inverse Probability Treatment Weighting (IPTW) | From index date to date of death or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months | OS 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 during this period were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Kaplan-Meier (weighted) method was used for analysis. |
| Secondary | OS Without Subsequent Therapy: Adjusted Using IPTW | From index date to date of death or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months | OS 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 during this period were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. OS of only those participants who initiated abiraterone and enzalutamide on the index date and did not receive subsequent systemic anti-neoplastic therapy were reported in this outcome measure. Kaplan-Meier (weighted) method was used for analysis. |
| Secondary | Time to Treatment Discontinuation (TTD): Adjusted Using IPTW | From index date to date of treatment discontinuation or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months | 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. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Discontinuation was defined as the earliest of 1) death, 2) abstracted end date for last enzalutamide or abiraterone drug episode that started within the index treatment line of therapy (LOT) (drug episodes for abstracted oral therapies from the Flatiron Drug Episode table), or 3) day before the start of next LOT. Participants who did not discontinue were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Kaplan-Meier (weighted) method was used for analysis. |
| Secondary | Time to Subsequent Therapy (TTST): Adjusted Using IPTW | From index date to date of start of next LOT or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months | TTST was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the start of next LOT. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Participants who did not start a new LOT were censored at their last available follow-up, which was defined as the earliest of 1) death, 2) end of data availability or 3) last participant contact. Kaplan-Meier (weighted) method was used for analysis. |
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): Adjusted Using Inverse Probability Treatment Weighting (IPTW) | From index date to date of death or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months | Analysis population included all participants included in this study, and were adjusted for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities) using IPTW method. As numbers were adjusted using IPTW, pseudo set was derived. Hence, numbers reported against Overall Number of Participants Analyzed (N) for both the arms differ from the unadjusted (raw) numbers presented in participant flow and baseline characteristics section. | Months | MEDIAN |
| SECONDARY | OS Without Subsequent Therapy: Adjusted Using IPTW | From index date to date of death or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months | Analysis population included a sub-set of participants included in this study, who did not receive subsequent systemic anti-neoplastic therapy. The evaluable number of participants for this outcome were adjusted for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities) using IPTW method. As numbers were adjusted using IPTW, pseudo sub-set was derived. Here, 'N' signifies participants evaluable for this outcome measure after applying ITPW. | Months | MEDIAN |
| SECONDARY | Time to Treatment Discontinuation (TTD): Adjusted Using IPTW | From index date to date of treatment discontinuation or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months | Analysis population included all participants included in this study, and were adjusted for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities) using IPTW method. As numbers were adjusted using IPTW, pseudo set was derived. Hence, numbers reported against Overall Number of Participants Analyzed for both the arms differ from the unadjusted (raw) numbers presented in participant flow and baseline characteristics section. | Months | MEDIAN |
| SECONDARY | Time to Subsequent Therapy (TTST): Adjusted Using IPTW | From index date to date of start of next LOT or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months | Analysis population included all participants included in this study, and were adjusted for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities) using IPTW method. As numbers were adjusted using IPTW, pseudo set was derived. Hence, numbers reported against Overall Number of Participants Analyzed for both the arms differ from the unadjusted (raw) numbers presented in participant flow and baseline characteristics 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): Adjusted Using Inverse Probability Treatment Weighting (IPTW) | Abiraterone | 24.63 | 95% Confidence Interval 22.93 to 26.33 | Months | |
| Overall Survival (OS): Adjusted Using Inverse Probability Treatment Weighting (IPTW) | Enzalutamide | 25.77 | 95% Confidence Interval 24.30 to 27.60 | Months | |
| OS Without Subsequent Therapy: Adjusted Using IPTW | Abiraterone Only | 14.03 | 95% Confidence Interval 12.37 to 15.63 | Months | |
| OS Without Subsequent Therapy: Adjusted Using IPTW | Enzalutamide Only | 17.73 | 95% Confidence Interval 14.87 to 20.83 | Months | |
| Time to Treatment Discontinuation (TTD): Adjusted Using IPTW | Abiraterone | 7.87 | 95% Confidence Interval 7.10 to 8.50 | Months | |
| Time to Treatment Discontinuation (TTD): Adjusted Using IPTW | Enzalutamide | 9.50 | 95% Confidence Interval 8.67 to 10.13 | Months | |
| Time to Subsequent Therapy (TTST): Adjusted Using IPTW | Abiraterone | 14.70 | 95% Confidence Interval 13.47 to 16.27 | Months | |
| Time to Subsequent Therapy (TTST): Adjusted Using IPTW | Enzalutamide | 17.90 | 95% Confidence Interval 16.40 to 19.80 | 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 | 1,316 | |
| Overall Study | STARTED | Enzalutamide | 1,415 | |
| Overall Study | COMPLETED | Abiraterone | 1,316 | |
| Overall Study | COMPLETED | Enzalutamide | 1,415 | |
| 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 | 1,007 | 1,316 |
| Total, all-cause mortality | Enzalutamide | 1,036 | 1,415 |
| 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
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42864777 | DERIVED |
Source PubMed
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.
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/NCT05968599
GET https://conductscience.org/api/trials/v1/NCT05968599/registered