Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (ARASENS)

Bayer

Status and phase: Completed; Phase 3

Conditions: Metastatic Hormone-sensitive Prostate Cancer

Treatments: Drug: Placebo; Drug: Standard ADT (androgen deprivation therapy); Drug: BAY1841788 / darolutamide (ODM-201); Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02799602

2015-002590-38 (EudraCT Number)

17777

Details and patient eligibility

About

The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

Full description

This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The study population will consist of approximately 1300 subjects with metastatic hormone sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive 600 mg (2 x 300 mg tablets) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total daily dose of 1200 mg, in addition to standard androgen deprivation therapy (ADT) and docetaxel. Subjects will be stratified at randomization for the extent of disease and for Alkaline Phosphatase levels. All subjects will be treated with ADT as standard therapy. Six cycles of docetaxel will be administered after randomization.

The subjects considered for inclusion in the study will have metastatic prostate cancer and will be candidates for ADT and docetaxel.

Treatment with darolutamide (ODM-201)/placebo will be administered until symptomatic progressive disease, change of antineoplastic therapy, unacceptable toxicity, until subject withdraws consent, withdrawal from the study at the discretion of the investigator or his/her designated associate(s), death, non-compliance, or if sponsor terminates the study.

Enrollment: 1,306 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of prostate.
• Metastatic disease
• Candidates for ADT and docetaxel.
• Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate bone marrow, liver and renal function

Exclusion criteria

• Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
• Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
• Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
• Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 5 years before randomization and from which the subject has been disease-free
• Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.
• Inability to swallow oral medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,306 participants in 2 patient groups, including a placebo group

BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel

Experimental group

Description:

Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel

Treatment:

Drug: Standard ADT (androgen deprivation therapy)

Drug: BAY1841788 / darolutamide (ODM-201)

Drug: Docetaxel

Placebo + standard ADT + Docetaxel

Placebo Comparator group

Description:

Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel

Treatment:

Drug: Placebo

Drug: Standard ADT (androgen deprivation therapy)

Drug: Docetaxel