Clinical trial NCT01091103: Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide
Official title: A Study Of Continuous Oral Dosing Of A Novel Antiandrogen Mdv3100, In Castration-resistant Bone Metastatic Prostate Cancer Patients Evaluating The Tumor Micro-enviroment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Progressive Castration-resistant Prostate Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
name: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
First posted: 2010-03-23
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.


Eligibility criteria: Inclusion Criteria:

* Confirmed prostate cancer
* Presence of metastatic disease to the bone
* Ongoing androgen deprivation therapy

Exclusion Criteria:

* Severe concurrent disease
* Metastases in the brain

Primary outcomes:
measure: Change From Baseline in Bone Marrow Testosterone
timeFrame: Baseline, Week 9
measure: Change From Baseline in Bone Marrow Dihydrotestosterone
timeFrame: Baseline, Week 9
measure: Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status
timeFrame: Baseline, Week 9
measure: Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status
timeFrame: Baseline, Week 9
Secondary outcomes:
measure: Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)
timeFrame: Baseline, Week 9
measure: Median Time to Study Drug Discontinuation
timeFrame: Duration of study treatment through the data cutoff, up to 3 years.
measure: Change From Baseline in Urinary N-Telopeptide
timeFrame: Baseline, Week 5
measure: Change From Baseline in Urinary N-Telopeptide
timeFrame: Baseline, Week 9
measure: Change From Baseline in Urinary N-Telopeptide
timeFrame: Baseline, Week 17
measure: Change From Baseline in Urinary N-Telopeptide
timeFrame: Baseline, Week 25
measure: Change From Baseline in Urinary N-Telopeptide
timeFrame: Baseline, Week 33
measure: Change From Baseline in Urinary N-Telopeptide
timeFrame: Baseline, Week 41
measure: Change From Baseline in Urinary N-Telopeptide
timeFrame: Baseline, Week 49
measure: Change From Baseline in Urinary N-Telopeptide
timeFrame: Baseline, Week 57
measure: Change From Baseline in Urinary N-Telopeptide
timeFrame: Baseline, Week 65
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
affiliation: Medivation, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Efstathiou E, Titus M, Wen S, Hoang A, Karlou M, Ashe R, Tu SM, Aparicio A, Troncoso P, Mohler J, Logothetis CJ. Molecular characterization of enzalutamide-treated bone metastatic castration-resistant prostate cancer. Eur Urol. 2015 Jan;67(1):53-60. doi: 10.1016/j.eururo.2014.05.005. Epub 2014 May 29.