A study of patients with prostate cancer who have previously been treated with docetaxel-based chemotherapy, where patients receive either study drug or placebo

AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy - AFFIRM

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013174-41-BE

Enrollment

1199

Registered

2009-09-03

Start date

2009-10-14

Completion date

Unknown

Last updated

2018-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy MedDRA version: 14.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Xtandi (enzalutamide) Product Name: MDV3100 Product Code: MDV3100 Pharmaceutical Form: Capsule, soft CAS Number: 915087-33-1 Other descriptive name: MDV3100 Concentration unit: mg milligra

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -Progressive prostate cancer; -One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel; -Medical or surgical castration with a testosterone level =65 years) yes F.1.3.1 Number of subjects for this age range 840

Exclusion criteria

Exclusion criteria: -Metastases in the brain or active epidural disease; -Another malignancy within the previous 5 years; -Clinically significant cardiovascular disease; -Gastrointestinal disorder affecting absorption. Open-Label Extension Criteria for Patients Randomized to the Placebo arm: Patients randomized to the placebo arm of the blinded portion of the study must NOT meet any of the following exclusion criteria: - Known or suspected brain metastasis; - Clinically significant cardiovascular disease

Design outcomes

Primary

Measure	Time frame
Main Objective: • To determine the benefit of MDV3100 as compared to placebo as assessed by overall survival.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy outcome is a comparison of overall survival between the MDV3100-treated and the placebo groups.;Timepoint(s) of evaluation of this end point: When the required number of deaths have occurred as specified in the protocol.	—

Measure

Time frame

Main Objective: • To determine the benefit of MDV3100 as compared to placebo as assessed by overall survival.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy outcome is a comparison of overall survival between the MDV3100-treated and the placebo groups.;Timepoint(s) of evaluation of this end point: When the required number of deaths have occurred as specified in the protocol.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Argentina, Australia, Austria, Belgium, Canada, Chile, France, Germany, Italy, Netherlands, Poland, South Africa, Spain, United Kingdom, United States

Contacts

Public ContactVice President Clinical Operations

Medivation, Inc.

info@medivation.com1415543-3470

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026