Trial · NCT01664923
Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
NCT01664923, Phase 2, Completed, Pfizer; results first posted 2016-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer. Trials, record NCT01664923. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01664923
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
- NCT number
- NCT01664923
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 396 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Prostate Cancer
- Interventions
- Enzalutamide, Bicalutamide
- First posted
- 2012-08-14
- Last updated
- 2019-01-30
- Results first posted
- 2016-05-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment. |
| Secondary | Time to PSA Progression | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment. |
| Secondary | Percentage of Participants With a PSA Response ≥ 50% | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | PSA response was defined as a reduction in PSA of at least 50% from baseline at any post baseline assessment confirmed by a second PSA assessment at least 3 weeks later. |
| Secondary | Duration of Radiographic PFS | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment. |
| Secondary | Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P) | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life. Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation. |
| Secondary | Best Overall Soft Tissue Response | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group. |
| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study drug until the end of open label phase (up to maximum duration of 65 months) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase \[up to maximum duration of 65 months\]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related. |
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 | Progression Free Survival (PFS) | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | Intent-to-treat population: all participants randomly assigned to study treatment. | months | MEDIAN |
| SECONDARY | Time to PSA Progression | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | Intent-to-treat population: all participants randomly assigned to study treatment. | months | MEDIAN |
| SECONDARY | Percentage of Participants With a PSA Response ≥ 50% | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | Evaluable intent-to-treat population: all participants randomly assigned to study treatment and had a baseline and at least 1 post baseline PSA measurement. | percentage of participants | NUMBER |
| SECONDARY | Duration of Radiographic PFS | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | All participants with metastatic disease at study entry and randomly assigned to study treatment. | months | MEDIAN |
| SECONDARY | Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P) | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | Intent-to-treat population: all participants randomly assigned to study treatment. | months | MEDIAN |
| SECONDARY | Best Overall Soft Tissue Response | From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. | All participants who were randomly assigned to study treatment and had metastatic and measurable soft tissue disease at screening. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study drug until the end of open label phase (up to maximum duration of 65 months) | Safety population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Enzalutamide | 19.4 | 95% Confidence Interval 16.5 to NA | months | |
| Progression Free Survival (PFS) | Bicalutamide | 5.7 | 95% Confidence Interval 5.6 to 8.1 | months | |
| Time to PSA Progression | Enzalutamide | NA | 95% Confidence Interval 19.4 to NA | months | |
| Time to PSA Progression | Bicalutamide | 8.3 | 95% Confidence Interval 5.7 to 8.5 | months | |
| Percentage of Participants With a PSA Response ≥ 50% | Enzalutamide | 81.3 | 95% Confidence Interval 75.0 to 86.5 | percentage of participants | |
| Percentage of Participants With a PSA Response ≥ 50% | Bicalutamide | 31.3 | 95% Confidence Interval 24.8 to 38.3 | percentage of participants | |
| Duration of Radiographic PFS | Enzalutamide | NA | 95% Confidence Interval 16.7 to NA | months | |
| Duration of Radiographic PFS | Bicalutamide | 8.3 | 95% Confidence Interval 8.1 to 11.1 | months | |
| Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P) | Enzalutamide | 8.4 | 95% Confidence Interval 6.3 to 11.4 | months | |
| Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P) | Bicalutamide | 8.3 | 95% Confidence Interval 6.1 to 11.1 | months |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period1:Double Blind Phase-29 Months | STARTED | Enzalutamide | 198 | |
| Period1:Double Blind Phase-29 Months | STARTED | Bicalutamide Then Enzalutamide | 198 | |
| Period1:Double Blind Phase-29 Months | Received Study Treatment | Enzalutamide | 197 | |
| Period1:Double Blind Phase-29 Months | Received Study Treatment | Bicalutamide Then Enzalutamide | 198 | |
| Period1:Double Blind Phase-29 Months | COMPLETED | Enzalutamide | 93 | |
| Period1:Double Blind Phase-29 Months | COMPLETED | Bicalutamide Then Enzalutamide | 38 | |
| Period1:Double Blind Phase-29 Months | NOT COMPLETED | Enzalutamide | 105 | |
| Period1:Double Blind Phase-29 Months | NOT COMPLETED | Bicalutamide Then Enzalutamide | 160 | |
| Period 2: Open-label Phase-36 Months | STARTED | Enzalutamide | 93 | |
| Period 2: Open-label Phase-36 Months | STARTED | Bicalutamide Then Enzalutamide | 38 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events2,553
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 | Abdominal pain | Gastrointestinal disorders | Enzalutamide | 15 | 197 | |
| other | Abdominal pain | Gastrointestinal disorders | DB Phase: Bicalutamide | 6 | 198 | |
| other | Abdominal pain | Gastrointestinal disorders | Open Label Phase: Bicalutamide Crossover to Enzalutamide | 1 | 37 | |
| other | Constipation | Gastrointestinal disorders | Enzalutamide | 29 | 197 | |
| other | Constipation | Gastrointestinal disorders | DB Phase: Bicalutamide | 33 | 198 | |
| other | Constipation | Gastrointestinal disorders | Open Label Phase: Bicalutamide Crossover to Enzalutamide | 6 | 37 | |
| other | Diarrhoea | Gastrointestinal disorders | Enzalutamide | 26 | 197 | |
| other | Diarrhoea | Gastrointestinal disorders | DB Phase: Bicalutamide | 29 | 198 | |
| other | Diarrhoea | Gastrointestinal disorders | Open Label Phase: Bicalutamide Crossover to Enzalutamide | 9 | 37 | |
| other | Nausea | Gastrointestinal disorders | Enzalutamide | 38 | 197 |
1 to 10 of 2,553Source ClinicalTrials.gov
See all 2,553 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enzalutamide | ||
| Total, all-cause mortality | DB Phase: Bicalutamide | ||
| Total, all-cause mortality | Open Label Phase: Bicalutamide Crossover to Enzalutamide | ||
| Total, other adverse events | Enzalutamide | 187 | 197 |
| Total, other adverse events | DB Phase: Bicalutamide | 179 | 198 |
| Total, other adverse events | Open Label Phase: Bicalutamide Crossover to Enzalutamide | 36 | 37 |
| Total, serious adverse events | Enzalutamide | 76 | 197 |
| Total, serious adverse events | DB Phase: Bicalutamide | 60 | 198 |
| Total, serious adverse events | Open Label Phase: Bicalutamide Crossover to Enzalutamide | 16 | 37 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01664923
GET https://conductscience.org/api/trials/v1/NCT01664923/results?page=2