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.

First Received on February 21, 2011. Last Updated on April 23, 2012 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborator:	Medivation, Inc.
Information provided by (Responsible Party):	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01302041

Purpose

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:

MedlinePlus related topics: Cancer Diabetes Medicines Prostate Cancer

U.S. FDA Resources

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 ]

Estimated Enrollment:	60
Study Start Date:	April 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MDV3100	Drug: MDV3100 Oral

Eligibility

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

Criteria

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

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

Locations

Belgium
Site 1003
Brussels, Belgium, B1090
Site 1001
Brussels, Belgium, 1200
Site 1004
Edegem, Belgium, 2650
Site 1002
Kortrijk, Belgium, 8500
Site 1005
Leuven, Belgium, 3000
Czech Republic
Site 3006
Olomouc, Czech Republic, 775 20
Site 3002
Prague 4, Czech Republic, 160 00
Denmark
Site 4004
Copenhagen, Denmark, 2100
Site 4002
Herlev, Denmark, 2730
Site 4001
Skejby, Denmark, 8200
Germany
Site 5005
Aachen, Germany, 52074
Site 5001
Bonn, Germany, 53105
Site 5007
Bonn, Germany, 53111
Site 5003
Hannover, Germany, 30625

Sponsors and Collaborators

Astellas Pharma Inc

Medivation, Inc.

Investigators

Study Director:

Use Central Contact

Astellas Pharma Europe BV

More Information

No publications provided

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:	April 23, 2012
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
hormone-naïve
prostate specific antigen
bone turnover

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male

Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012