Clinical trial · Interventional
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
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)
NCT04736199CI-TRIAL-00104179ARANOTEcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen deprivation therapy (ADT) | Other | — | UNRESOLVED |
| Darolutamide (Nubeqa, BAY1841788) | Drug | Darolutamide | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Darolutamide+ADT
- 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
- interventionNames
- Drug: Darolutamide (Nubeqa, BAY1841788)
- Other: Androgen deprivation therapy (ADT)
- type
- PLACEBO_COMPARATOR
- label
- Placebo+ADT
- description
- Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy
- interventionNames
- Drug: Placebo
- Other: Androgen deprivation therapy (ADT)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDSaad F, Shore N, Vjaters E, Olmos D, Littleton N, Testa I, Mo M, Verholen F, Srinivasan S, Haresh KP. Darolutamide Plus Androgen-deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase 3 ARANOTE Trial. Eur Urol. 2026 Aug 12:S0302-2838(26)02313-4. doi: 10.1016/j.eururo.2026.07.026. Online ahead of print. PMID 42586872
- DERIVEDMorgans AK, Haresh KP, Jievaltas M, Olmos D, Shore ND, Vjaters E, Xing N, Mohamed AF, Littleton N, Srinivasan S, Verholen F, Saad F. Pain and health-related quality-of-life outcomes with darolutamide in metastatic hormone-sensitive prostate cancer (ARANOTE): secondary and exploratory analyses of a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 May;27(5):614-624. doi: 10.1016/S1470-2045(26)00014-8. Epub 2026 Apr 9. PMID 41969015
- DERIVEDSaad F, Vjaters E, Shore N, Olmos D, Xing N, Pereira de Santana Gomes AJ, Cesar de Andrade Mota A, Salman P, Jievaltas M, Ulys A, Jakubovskis M, Kopyltsov E, Han W, Nevalaita L, Testa I, Le Berre MA, Kuss I, Haresh KP; ARANOTE Study Investigators. Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial. J Clin Oncol. 2024 Dec 20;42(36):4271-4281. doi: 10.1200/JCO-24-01798. Epub 2024 Sep 16. PMID 39279580