Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE)

Bayer

Status and phase: Active, not recruiting; Phase 3

Conditions: Prostatic Neoplasms

Treatments: Other: Androgen deprivation therapy (ADT); Drug: Placebo; Drug: Darolutamide (Nubeqa, BAY1841788)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04736199

21140

2020-003093-48 (EudraCT Number)

2022-502244-12-00 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 669 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of prostate
• Metastatic disease
• Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but not earlier than 12 weeks before randomization
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
• Adequate bone marrow, liver and renal function

Exclusion criteria

• Prior treatment with: LHRH agonist/antagonists except neoadjuvant and /or adjuvant therapy; Second-generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors; Cytochrome P17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as anti-cancer treatment for prostate cancer; Chemotherapy including docetaxel or immunotherapy for prostate cancer; Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization; Radiopharmaceuticals; Any other anti-cancer treatment for prostate cancer, excluding local therapies and ADT.
• Treatment with radiotherapy within 2 weeks before randomization
• Contraindication to iodinated CT and gadolinium chelate MRI intravenous contrast agent(s)
• 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)
• Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
• A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
• Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
• Inability to swallow oral medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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669 participants in 2 patient groups, including a placebo group

Darolutamide+ADT

Experimental group

Description:

Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy

Treatment:

Drug: Darolutamide (Nubeqa, BAY1841788)

Other: Androgen deprivation therapy (ADT)

Placebo+ADT

Placebo Comparator group

Description:

Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy

Treatment:

Drug: Placebo

Other: Androgen deprivation therapy (ADT)