Clinical trial NCT01547299: Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
Official title: A Randomized, Open-label, Phase 2 Study Of Mdv3100 As A Neoadjuvant Therapy For Patients Undergoing Prostatectomy For Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
prostatectomy
neoadjuvant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
name: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
First posted: 2012-03-07
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Pathologic Complete Response Rate
timeFrame: Day 180
Secondary outcomes:
measure: Percentage of Participants With Positive Surgical Margins
timeFrame: Day 180
measure: Percentage of Participants With Extracapsular Extension: Local Review
timeFrame: Day 180
measure: Percentage of Participants With Extracapsular Extension: Central Review
timeFrame: Day 180
measure: Percentage of Participants With Positive Seminal Vesicles
timeFrame: Day 180
measure: Percentage of Participants With Positive Lymph Nodes
timeFrame: Day 180
measure: Prostate-Specific Antigen (PSA) Nadir
timeFrame: Day 195
measure: Time to Prostate-Specific Antigen (PSA) Nadir
timeFrame: Day 195
measure: Percentage of Participants With Reduction in Prostate-Specific Antigen (PSA)
timeFrame: Day 195
measure: Health-Related Quality of Life (HRQoL): Number of Participants With The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score
timeFrame: Day 180
measure: Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score
timeFrame: Day 180
measure: Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score
timeFrame: Day 180
measure: Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score
timeFrame: Day 180
measure: Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score
timeFrame: Day 180
measure: Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score
timeFrame: Day 180
measure: Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 General Health Domain Score
timeFrame: Day 180
measure: Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Physical Functioning Domain Score
timeFrame: Day 180
measure: Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Role-Emotional Domain Score
timeFrame: Day 180
measure: Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Mental Component Summary
timeFrame: Day 180
measure: Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT)
timeFrame: Day 180
measure: Pharmacodynamic Effects: Tissue Testosterone
timeFrame: Day 180
measure: Pharmacodynamic Effects: Assessment of Apoptosis
timeFrame: Day 180
measure: Pharmacodynamic Effects: Assessment of Mitotic Index
timeFrame: Day 180
measure: Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling as Measured by Intensity of Androgen Receptor Immunohistochemical (IHC) Staining
timeFrame: Day 180
measure: Serum Dihydrotestosterone (DHT): Baseline
timeFrame: Baseline
measure: Serum Dihydrotestosterone (DHT): Day 180
timeFrame: Day 180
measure: Change From Baseline in Serum Dihydrotestosterone (DHT) at Day 180
timeFrame: Day 180
measure: Serum Testosterone: Baseline
timeFrame: Baseline
measure: Serum Testosterone: Day 180
timeFrame: Day 180
measure: Change From Baseline in Serum Testosterone at Day 180
timeFrame: Day 180
measure: Number of Participants With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation
timeFrame: From baseline up to 210 days
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
city: Seattle
country: United States
state: Washington
city: Vancouver
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: