A Study to Test if MDV3100 is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

This study is ongoing, but not recruiting participants.
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: February 21, 2011
Last updated: October 26, 2015
Last verified: October 2015
To determine the effect of MDV3100 on Prostate Specific Antigen (PSA), male sex hormones, bone turnover, lipid and glycemic profile (insulin and blood glucose).

Condition Intervention Phase
Prostate Cancer
Drug: MDV3100
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label, Single-arm, Efficacy and Safety Study of MDV3100 in Patients With Hormone-naïve Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The proportion of subjects with a PSA response [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
    A PSA response is defined as a decline from baseline in PSA level of 80% or greater at week 25

Secondary Outcome Measures:
  • Safety assessed through evaluation of Adverse Events and Serious Adverse Events [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • Pharmacodynamic effect of MDV3100 [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • The Pharmacokinetic assessed by analysis of Ctrough of MDV3100 and its major metabolite M2 [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • The effect of MDV3100 on PSA dynamics and kinetics [ Time Frame: Day 169 ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDV3100 Drug: MDV3100
Other Name: Enzalutamide


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
  • Asymptomatic from prostate cancer
  • Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
  • PSA ≥ 2 ng/mL at screening

Exclusion Criteria:

Has previously or is currently receiving:

  • Hormonal therapy with intent to treat prostate cancer
  • Systemic glucocorticoids
  • Chemotherapy with the intent to treat prostate cancer
  • Opiate analgesics for pain from prostate cancer
  • Radiation therapy for treatment of the primary tumor or metastases
  • Has history of known or suspected brain or skull metastases or leptomeningeal disease
  • Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack
  • Clinically significant cardiovascular disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302041

Site BE1001 Clinique Universitaire Saint Luc UCL
Brussels, Belgium, 1200
Site BE1003 Universitair Ziekenhuis Brussel
Brussels, Belgium, B1090
Site BE1002 AZ Groeninge, Campus Vercruysselaan
Kortrijk, Belgium, 8500
Site BE1005 Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Czech Republic
Site CZ3006 Faculty Hospital Olomouc
Olomouc, Czech Republic, 775 20
Site CZ3002 Androgeos, spol. s.r.o
Prague 4, Czech Republic, 160 00
Site DK4004 Rigshospitalet
Copenhagen, Denmark, 2100
Site DK4002 Herlev University Hospital
Herlev, Denmark, 2730
Site DK4001 Skejby Sygehus
Skejby, Denmark, 8200
Site DE5005 Aachen University / Dept. of Urology
Aachen, Germany, 52074
Site DE5001 Bonn University / Dept. of Urology
Bonn, Germany, 53105
Site DE5007 Medizinisches Zentrum Bonn
Bonn, Germany, 53111
Site DE5003 Kliniken der Medizinischen Hochschule Hannover
Hannover, Germany, 30625
Sponsors and Collaborators
Astellas Pharma Inc
Medivation, Inc.
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01302041     History of Changes
Other Study ID Numbers: 9785-CL-0321  2010-021287-16 
Study First Received: February 21, 2011
Last Updated: October 26, 2015
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Astellas Pharma Inc:
Prostate Cancer
prostate specific antigen
bone turnover

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on February 04, 2016