Trial · NCT02003924
Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
NCT02003924, Phase 3, Completed, Pfizer; results first posted 2018-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer. Trials, record NCT02003924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02003924
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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 in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
- NCT number
- NCT02003924
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,401 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the Prostate
- Interventions
- Enzalutamide, Placebo
- First posted
- 2013-12-06
- Last updated
- 2026-01-27
- Other registries' IDs
- eudract:2012-005665-12
- Results first posted
- 2018-07-12
Source ClinicalTrials.gov
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Metastasis Free Survival (MFS) | From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review \[BICR\]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,\[RECIST 1.1\])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates. |
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression | From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates. |
| Secondary | Time to First Use of New Antineoplastic Therapy | From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates. |
| Secondary | Overall Survival | From randomization until death (up to a maximum of 68.8 months) | Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates. |
| Secondary | Time to Pain Progression | From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates. |
| Secondary | Time to First Use of Cytotoxic Chemotherapy | From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates. |
| Secondary | Chemotherapy-Free Disease Specific Survival | From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates. |
| Secondary | Chemotherapy-Free Survival | From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates. |
| Secondary | Percentage of Participants With Prostate Specific Antigen (PSA) Response | From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later. |
| Secondary | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 | The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was 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 which ranged from 0 to 156 where higher scores represented better quality of life. |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 registered outcomesOutcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Metastasis Free Survival (MFS) | From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | The intent-to-treat (ITT) population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. | months | MEDIAN |
| SECONDARY | Time to Prostate-Specific Antigen (PSA) Progression | From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. | months | MEDIAN |
| SECONDARY | Time to First Use of New Antineoplastic Therapy | From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. | months | MEDIAN |
| SECONDARY | Overall Survival | From randomization until death (up to a maximum of 68.8 months) | The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. | months | MEDIAN |
| SECONDARY | Time to Pain Progression | From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. | months | MEDIAN |
| SECONDARY | Time to First Use of Cytotoxic Chemotherapy | From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. | months | MEDIAN |
| SECONDARY | Chemotherapy-Free Disease Specific Survival | From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. | months | MEDIAN |
| SECONDARY | Chemotherapy-Free Survival | From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Prostate Specific Antigen (PSA) Response | From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) | The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Overall number of participants analyzed' = participants with baseline and at least one post-baseline PSA assessment. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 | The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified timepoints. | units on a scale | MEAN |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 outcomesResults by group3,732
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Metastasis Free Survival (MFS) | Enzalutamide 160 mg | 36.6 | 95% Confidence Interval 33.1 to NA | months | |
| Metastasis Free Survival (MFS) | Placebo | 14.7 | 95% Confidence Interval 14.2 to 15.0 | months | |
| Time to Prostate-Specific Antigen (PSA) Progression | Enzalutamide 160 mg | 37.2 | 95% Confidence Interval 33.1 to NA | months | |
| Time to Prostate-Specific Antigen (PSA) Progression | Placebo | 3.9 | 95% Confidence Interval 3.8 to 4.0 | months | |
| Time to First Use of New Antineoplastic Therapy | Enzalutamide 160 mg | 39.6 | 95% Confidence Interval 37.7 to NA | months | |
| Time to First Use of New Antineoplastic Therapy | Placebo | 17.7 | 95% Confidence Interval 16.2 to 19.7 | months | |
| Overall Survival | Enzalutamide 160 mg | 67.0 | 95% Confidence Interval 64.0 to NA | months | |
| Overall Survival | Placebo | 56.3 | 95% Confidence Interval 54.4 to 63.0 | months | |
| Time to Pain Progression | Enzalutamide 160 mg | 18.5 | 95% Confidence Interval 17.0 to 22.1 | months | |
| Time to Pain Progression | Placebo | 18.4 | 95% Confidence Interval 14.8 to 22.1 | months |
1 to 10 of 3,732Source ClinicalTrials.gov
See all 3,732 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Phase | STARTED | Enzalutamide 160 mg | 933 | |
| Double-blind Phase | STARTED | Placebo | 468 | |
| Double-blind Phase | STARTED | Placebo Participants Crossover to Enzalutamide 160 mg | 0 | |
| Double-blind Phase | Treated | Enzalutamide 160 mg | 930 | |
| Double-blind Phase | Treated | Placebo | 465 | |
| Double-blind Phase | Treated | Placebo Participants Crossover to Enzalutamide 160 mg | 0 | |
| Double-blind Phase | COMPLETED | Enzalutamide 160 mg | 478 | |
| Double-blind Phase | COMPLETED | Placebo | 87 | |
| Double-blind Phase | COMPLETED | Placebo Participants Crossover to Enzalutamide 160 mg | 0 | |
| Double-blind Phase | NOT COMPLETED | Enzalutamide 160 mg | 455 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events1,212
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 | Asthenia | General disorders | Enzalutamide 160 mg | 94 | 930 | |
| other | Asthenia | General disorders | Placebo | 32 | 465 | |
| other | Asthenia | General disorders | Placebo Patients Crossover to Enzalutamide 160 mg | 10 | 87 | |
| other | Fatigue | General disorders | Enzalutamide 160 mg | 348 | 930 | |
| other | Fatigue | General disorders | Placebo | 73 | 465 | |
| other | Fatigue | General disorders | Placebo Patients Crossover to Enzalutamide 160 mg | 13 | 87 | |
| other | Constipation | Gastrointestinal disorders | Enzalutamide 160 mg | 121 | 930 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 39 | 465 | |
| other | Constipation | Gastrointestinal disorders | Placebo Patients Crossover to Enzalutamide 160 mg | 1 | 87 | |
| other | Diarrhoea | Gastrointestinal disorders | Enzalutamide 160 mg | 112 | 930 |
1 to 10 of 1,212Source ClinicalTrials.gov
See all 1,212 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enzalutamide 160 mg | 285 | 930 |
| Total, all-cause mortality | Placebo | 173 | 465 |
| Total, all-cause mortality | Placebo Patients Crossover to Enzalutamide 160 mg | 4 | 87 |
| Total, other adverse events | Enzalutamide 160 mg | 762 | 930 |
| Total, other adverse events | Placebo | 299 | 465 |
| Total, other adverse events | Placebo Patients Crossover to Enzalutamide 160 mg | 45 | 87 |
| Total, serious adverse events | Enzalutamide 160 mg | 372 | 930 |
| Total, serious adverse events | Placebo | 100 | 465 |
| Total, serious adverse events | Placebo Patients Crossover to Enzalutamide 160 mg | 12 | 87 |
Source ClinicalTrials.gov
Papers11
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 |
|---|---|
Enzalutamide 160 mg vs Placebo: Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0 | Trial comparisons |
| Enzalutamide 160 mg vs Placebo: Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) | 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/NCT02003924
GET https://conductscience.org/api/trials/v1/NCT02003924/registered?page=2