Study Details

A study to test if enzalutamide is effective and safe in prostate cancer patients who have never had hormone therapy

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01302041

Astellas Study ID

The unique identification code given by the study sponsor.

9785-CL-0321

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2010-021287-16

Condition

Prostate Cancer

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 years - N/A

Sex

Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

May 2011 - Apr 2017

Masking

None (Open Label)

Enrollment number

67

A Phase 2, Open-label, Single-arm, Efficacy and Safety Study of Enzalutamide (MDV3100) in Patients with Hormone-naïve Prostate Cancer

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site DE5008

Tubingen, Germany, 72076

Site DE5005

Aachen, Germany, 51074

Site BE1002

Kortrijk, Belgium, 8500

Site BE1003

Brussels, Belgium, 1090

Site BE1005

Leuven, Belgium, 3000

Site BE1006

Turnhout, Belgium, 2300

Site DK4001

Aarhus N, Denmark, 8200

Site DK4002

Herlev, Denmark, 2730

Site BE1004

Edegem, Belgium, 2650

Site BE1001

Brussels, Belgium, 1200

Site DE5007

Bonn, Germany, 53111

Site DE5003

Hannover, Germany, 30625

Site DE5001

Bonn, Germany, 53105

Site CZ3006

Olomouc, Czech Republic, 77520

Site DK4004

Copenhagen, Denmark, DK-2100

Site CZ3002

Praha 6, Czech Republic, 16000

Site DK4003

Viborg, Denmark, 8800