NCT04736199进行中（未招募）3 期
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)
Bayer180 个研究点 分布在 11 个国家目标入组 669 人开始时间: 2021年2月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 669
- 试验地点
- 180
- 主要终点
- Radiological Progression-free Survival (rPFS) Assessed by Central Review
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Darolutamide+ADT
Experimental
Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy
干预措施: Darolutamide (Nubeqa, BAY1841788) (Drug)
Placebo+ADT
Placebo Comparator
Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy
干预措施: Placebo (Drug)
Placebo+ADT
Placebo Comparator
Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy
干预措施: Androgen deprivation therapy (ADT) (Other)
Darolutamide+ADT
Experimental
Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy
干预措施: Androgen deprivation therapy (ADT) (Other)
结局指标
主要结局
Radiological Progression-free Survival (rPFS) Assessed by Central Review
时间窗: From randomization to the date when 222 rPFS events were observed, approximately 36 months
rPFS used conventional imaging method (99mTc-phosphonate bone scan, CT/MRI scan). rPFS was defined as the time from the date of randomization to the date of progressive disease in malignant soft tissue lesions, progressive disease in malignant bone lesions, or death due to any cause, whichever occurs first. Malignant soft tissue lesions were assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and malignant bone lesions were assessed by Prostate Cancer Clinical Trials Working Group (PCWG3) criteria.
次要结局
- Overall Survival (OS)(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
- Time to Castration-Resistant Prostate Cancer (CRPC)(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
- Time to Initiation of Subsequent Anti-cancer Therapy(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
- Time to PSA Progression(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
- PSA Undetectable Rates (<0.2 ng/mL)(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
- Time to Pain Progression(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
- Number of Participants With Adverse Events as a Measure of Safety(From start of study drug administration until 30 days after the last administration)
研究者
研究点 (180)
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相关资讯
Darolutamide Gains FDA Approval for Metastatic Hormone-Sensitive Prostate Cancer Following ARANOTE Trial Success- Darolutamide (Nubeqa) received FDA approval on June 3, 2025, for treating metastatic hormone-sensitive prostate cancer based on the ARANOTE trial results.
- The ARANOTE trial demonstrated efficacy of darolutamide plus androgen deprivation therapy as a doublet regimen, expanding treatment options beyond existing triplet therapies.
- NCCN guidelines now include four Category 1 preferred oral agents for mHSPC: abiraterone, apalutamide, enzalutamide, with darolutamide expected to be upgraded from Category 2B status.
- The approval provides patients with low-volume metachronous disease an additional oral treatment option that minimizes adverse events while maintaining aggressive therapeutic approach.last yearFDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer Based on ARANOTE Trial Results- The FDA has approved darolutamide (Nubeqa) for treating patients with metastatic castration-sensitive prostate cancer, expanding its approved indications beyond the previously approved combination with docetaxel.
- The approval was based on the phase 3 ARANOTE trial, which demonstrated that darolutamide significantly improved radiographic progression-free survival compared to placebo when combined with androgen deprivation therapy.
- In the 669-patient study, median radiographic progression-free survival was not reached with darolutamide versus 25.0 months with placebo, representing a 46% reduction in disease progression risk.
- The safety profile remained consistent with previous darolutamide studies, with hypertension and anemia being the most common grade 3/4 adverse events observed in the treatment arm.last yearFDA Accepts Darolutamide sNDA for mHSPC Based on ARANOTE Trial Data- The FDA has accepted a supplemental new drug application (sNDA) for darolutamide plus androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC).
- The sNDA is supported by the phase 3 ARANOTE trial, which showed a significant improvement in radiographic progression-free survival (rPFS) with darolutamide plus ADT.
- Patients treated with darolutamide plus ADT achieved a median rPFS that was not reached compared to 25.0 months in the placebo plus ADT group.
- If approved, this would expand the indication for darolutamide in mHSPC, offering an additional treatment option for patients.last yearFDA Accepts sNDA for Darolutamide Plus ADT in Metastatic Hormone-Sensitive Prostate Cancer- The FDA has accepted a supplemental new drug application (sNDA) for darolutamide plus androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC).
- The sNDA is supported by data from the phase 3 ARANOTE trial, which demonstrated a 46% reduction in radiographic progression or death with darolutamide/ADT compared to placebo/ADT.
- Darolutamide is already approved for mHSPC in combination with docetaxel and as a monotherapy for nonmetastatic castration-resistant prostate cancer.
- If approved, this expanded indication would provide an additional treatment option for mHSPC patients, both with and without chemotherapy.last yearFDA Accepts Darolutamide sNDA for Metastatic Hormone-Sensitive Prostate Cancer- The FDA has accepted a supplemental new drug application (sNDA) for darolutamide plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC).
- The sNDA is based on the phase 3 ARANOTE trial, which showed a significant improvement in radiographic progression-free survival (rPFS) with darolutamide plus ADT.
- Patients treated with darolutamide plus ADT achieved a median rPFS that was not reached compared to 25.0 months with placebo plus ADT.
- If approved, this would expand the indication for darolutamide in mHSPC, offering an additional treatment option for patients.last year
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