2024-512132-29-00招募中2 期
SAKK 08/23: Addition of Darolutamide to first line treatment of mCRPC: a randomized open label phase II trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- Radiographic progression-free survival.
研究概览
简要总结
The main objective is to assess the efficacy of darolutamide, used in addition to physician-choice standard of care and then in maintenance therapy, on radiographic progression-free survival (rPFS) for patients in the first line setting of mCRPC.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
- •Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists)
- •Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial
- •Metastatic disease, documented by imaging according to PCWG3 criteria
- •Prior response to ARPI for at least 12 months in the mHSPC setting.
- •Adequate bone marrow, hepatic and renal functions.
排除标准
- •Presence of a small cell component.
- •Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of darolutamide.
- •Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
- •Prior systemic therapy for metastatic castration-resistant disease.
- •Prior chemotherapy for mHSPC, except docetaxel.
- •Prior LuPSMA or radium 223 for prostate cancer.
- •Concomitant use of other anti-cancer drugs or radiotherapy except for local pain control and GnRH analogues.
- •Severe or uncontrolled cardiovascular disease.
- •Acute exacerbations of chronic illnesses, serious infections, or major surgery before start of treatment.
- •Clinical or radiological evidence of current spinal cord compression.
- •Any concomitant drugs contraindicated for use with darolutamide or known hypersensitivity to darolutamide.
结局指标
主要结局
Radiographic progression-free survival.
Radiographic progression-free survival.
次要结局
- Overall survival.
- Time to symptomatic/clinical progression.
- Time to PSA progression (defined according to PCWG3).
- Event-free survival (EFS) – event being defined as one of the following: - death from any cause - presence of radiographic progression and symptomatic/clinical progression; - presence of radiographic progression and PSA progression; - presence of symptomatic/clinical progression and PSA progression
- Objective response rate according to RECIST.
- PSA response (30%, 50%, 90% and best).
- Duration of PSA response (50%).
- AEs.
研究者
Richard Cathomas
Scientific
Swiss Group for Clinical Cancer Research
研究点 (20)
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