Phase 2
N=52
Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01547299 ↗Enrolled (actual)
52
Serious AEs
9.6%
Results posted
Apr 2015
Primary outcome: Primary: Pathologic Complete Response Rate — 8.7; 0.0; 4.3; 0.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Enzalutamide (Drug); Leuprolide (Drug); Dutasteride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Pfizer
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response Rate |
8.7; 0.0; 4.3; 0.0 | — |
| SECONDARY Percentage of Participants With Positive Surgical Margins |
4.3; 12.0; 21.7; 16.0 | — |
| SECONDARY Percentage of Participants With Extracapsular Extension: Local Review |
26.1; 36.0 | — |
| SECONDARY Percentage of Participants With Extracapsular Extension: Central Review |
56.5; 70.8 | — |
| SECONDARY Percentage of Participants With Positive Seminal Vesicles |
30.4; 36.0; 30.4; 36.0 | — |
| SECONDARY Percentage of Participants With Positive Lymph Nodes |
26.1; 4.0; 26.1; 4.0 | — |
| SECONDARY Prostate-Specific Antigen (PSA) Nadir |
0.04; 0.51 | — |
| SECONDARY Time to Prostate-Specific Antigen (PSA) Nadir |
5.09; 6.01 | — |
| SECONDARY Percentage of Participants With Reduction in Prostate-Specific Antigen (PSA) |
92.0; 29.6; 100.0; 100.0; 100.0; 63.0 | — |
| SECONDARY Health-Related Quality of Life (HRQoL): Number of Participants With The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score |
11; 10; 4; 6; 1; 0 | — |
| SECONDARY Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score |
11; 12; 4; 5; 0; 0 | — |
| SECONDARY Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score |
7; 5; 9; 7; 0; 4 | — |
| SECONDARY Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score |
10; 10; 3; 7; 3; 1 | — |
| SECONDARY Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score |
11; 11; 2; 7; 3; 0 | — |
| SECONDARY Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score |
9; 6; 5; 11; 2; 1 | — |
| SECONDARY Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 General Health Domain Score |
5; 5; 9; 6; 2; 7 | — |
| SECONDARY Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Physical Functioning Domain Score |
3; 2; 12; 15; 1; 1 | — |
| SECONDARY Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Role-Emotional Domain Score |
3; 1; 9; 10; 4; 7 | — |
| SECONDARY Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Mental Component Summary |
4; 1; 8; 11; 4; 5 | — |
| SECONDARY Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT) |
0.04; 3.34 | — |
| SECONDARY Pharmacodynamic Effects: Tissue Testosterone |
0.18; 0.90 | — |
| SECONDARY Pharmacodynamic Effects: Assessment of Apoptosis |
— | — |
| SECONDARY Pharmacodynamic Effects: Assessment of Mitotic Index |
0.9; 2.6 | — |
| SECONDARY Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling as Measured by Intensity of Androgen Receptor Immunohistochemical (IHC) Staining |
0.0; 0.0; 5.6; 0.0; 27.8; 5.3 | — |
| SECONDARY Serum Dihydrotestosterone (DHT): Baseline |
0.34; 0.29 | — |
| SECONDARY Serum Dihydrotestosterone (DHT): Day 180 |
0.01; 0.51 | — |
| SECONDARY Change From Baseline in Serum Dihydrotestosterone (DHT) at Day 180 |
-0.33; 0.25 | — |
| SECONDARY Serum Testosterone: Baseline |
4.10; 3.69 | — |
| SECONDARY Serum Testosterone: Day 180 |
0.12; 9.76 | — |
| SECONDARY Change From Baseline in Serum Testosterone at Day 180 |
-4.00; 5.74 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation |
0; 0; 3; 0; 0; 0 | — |
Summary
The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.
Eligibility Criteria
Inclusion Criteria
- Willing to provide informed consent
- 18 years of age or older
- Histologically confirmed adenocarcinoma of the prostate
- Must be a candidate for radical prostatectomy and considered surgically resectable
Exclusion Criteria
- Stage T4 prostate cancer by clinical or radiologic evaluation
- Treatment with an investigational agent within 4 weeks prior to randomization
- Received therapy for other neoplastic disorders within 5 years
- Hypogonadism or severe androgen deficiency
Data sourced from ClinicalTrials.gov (NCT01547299). 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.