A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) (ARANOTE)

  • End date
    Sep 26, 2025
  • participants needed
  • sponsor
Updated on 23 October 2022


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.

Condition Prostatic Neoplasms
Treatment Placebo, Androgen Deprivation Therapy (ADT), Darolutamide (Nubeqa, BAY1841788)
Clinical Study IdentifierNCT04736199
Last Modified on23 October 2022


Yes No Not Sure

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
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