Phase 2
Completed N=227
A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance
Source: ClinicalTrials.gov NCT02799745 ↗Enrolled (actual)
227
Serious AEs
12.9%
Results posted
Nov 2021
Primary outcomePrimary: Time to Prostate Cancer Progression — NA; NA Months — p=0.016
Summary
The primary purpose of this study was to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Prostate Cancer Progression |
NA; NA | 0.016 sig |
| SECONDARY Number of Participants With Adverse Events (AEs) |
19; 10; 103; 67 | — |
| SECONDARY Percentage of Participants Reported Negative Biopsies for Cancer |
35.1; 14.2; 19.0; 12.0 | 0.00 sig |
| SECONDARY Change From Baseline in Percent of Cancer Positive Cores at Month 12 and 24 |
-14.2; -1.9; -7.3; -0.8 | <0.001 sig |
| SECONDARY Time to Prostate-specific Antigen (PSA) Progression |
14.82; 8.80 | 0.032 sig |
| SECONDARY Percentage of Participants With Secondary Rise in Serum PSA |
24.6; 69.0; 92.0; 92.8; 100.0; 96.2 | 0.000 sig |
| SECONDARY Change From Baseline in Brief Fatigue Inventory (BFI) Questionnaire Composite Scores to Months 3, 6, 12, 18 and 24 |
0.7; 0.0; 1.0; -0.1; 1.2; 0.1 | — |
| SECONDARY Change From Baseline in 12-Item Short Form Survey (SF-12) Questionnaire Composite Score to Months 6, 12, 18, 24 - Mental Component Summary |
-1.6; -0.1; -2.3; -1.7; 0.0; -0.5 | — |
| SECONDARY Change From Baseline in SF-12 Questionnaire Composite Score to Months 6, 12, 18, 24 - Physical Component Summary |
-2.8; 0.1; -3.9; -0.9; -3.9; -0.4 | — |
| SECONDARY Change From Baseline in The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Assessment Scores at Months 6, 12, 18 and 24 |
2.2; 0.2; -1.1; 0.4; -1.7; -0.5 | — |
| SECONDARY Change From Baseline in EPIC Sexual Assessment Scores at Months 6, 12, 18 and 24 |
-26.7; -2.3; -30.5; -2.9; -9.5; -2.1 | — |
| SECONDARY Change From Baseline in EPIC Urinary Assessment Scores at Month 6, 12, 18 and 24 |
-2.7; 0.7; -4.2; 0.3; -1.6; 0.2 | — |
| SECONDARY Change From Baseline in Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Scores at Months 6, 12, 18 and 24 |
-1.6; -0.5; -0.8; -0.0; -1.3; -0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically proven adenocarcinoma of the prostate diagnosed (with ≥10 core biopsy) within 6 months of screening. The biopsy that was used for this diagnosis must be submitted for central pathology review.
- Prostate cancer categorized (as determined by central pathology review) as low risk is defined as T1c-T2a, PSA 5 years OR intermediate risk is defined as T2b-T2c, PSA 5 years. Prostate cancer categorized (as determined by central pathology review) to the very low risk category (T1c, GS ≤6, PSA 3 months
- Presence of metastatic disease
- History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months of screening
- Absolute neutrophil count 1.5 times the upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 X ULN at screening
- Creatinine > 177 μmol/L (> 2 mg/dL) at screening
- Albumin 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening Visit
- Known hypersensitivity to enzalutamide or any of its components.
- Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to screening
Data sourced from ClinicalTrials.gov (NCT02799745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.