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The trial is taking place at:
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ONCOVIDA | Santiago, Chile

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

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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

662 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

662 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)

Trial contacts and locations

131

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Data sourced from clinicaltrials.gov

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