A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Docetaxel Combined With Platinum-based Drugs Compared With Docetaxel Alone for Metastatic Hormone-sensitive Prostate Cancer Patients Carrying DNA Repair Mutation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to Metastatic Castration-Resistant Prostate Cancer (mCRPC)
研究概览
简要总结
This randomized controlled trial was designed to evaluate the efficacy and safety of Docetaxel combined with Platinum-based drugs compared with Docetaxel alone for metastatic hormone-sensitive prostate cancer patients carrying DNA repair mutation.
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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥ 40 and ≤75 years of age.
- •All patients must have been histologically diagnozed of prostate cancer.
- •Metastatic disease confirmed by imaging: positive bone scan, or soft tissue or visceral metastases confirmed by abdominal/pelvic/chest contrast CT or MRI or PSMA PET-CT scan.
- •Participants who were treated with androgen deprivation therapy (ADT) (LHRH agonist/antagonist or orchectomy) with or without first-generation anti-androgens within 12 weeks prior to random assignment must maintain serum testosterone castration levels, i.e., ≤50 ng/dL (≤ 1.75 nmol/L) during the study period. First-generation anti-androgens must be discontinued at least 1 day before the start of study therapy.
- •Participants must carry one of the following DNA repair gene mutation: 1) HRR-related genes: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L; 2) Lynch syndrome-related genes: EPCAM, MLH1, MSH2, MSH6, PMS
- •Eastern Cooperative Oncology Group (ECOG) physical condition score ≤
- •Patients must have adequate hematologic function, hepatic function and renal function within 28 days prior to registration.
- •Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
- •Sexually active male subjects and their partner must agree the use of condoms as an effective contraceptive method and to avoid sperm donation during the whole treatment and within 4 weeks after the end of treatment.
排除标准
- •Patients with neuroendocrine, small cell, or signet ring cell histological features are not eligible.
- •Patients with brain/meningeal metastases are not eligible..
- •Patients previously received any of the following treatments are not eligible: 1) LHRH agonists/antagonists within 12 weeks prior to the start of study therapy; 2) Second generation androgen receptor (AR) inhibitors, such as enzaluamine, dalotamide, apatamide, etc; 3) Cytochrome P17 enzyme inhibitors (e.g., abiraterone acetate or oral ketoconazole) as antitumor therapy for PCa; 4) Chemotherapy (including docetaxel) or immunotherapy for PCa; 5) Systemic corticosteroids > 10 mg/day equivalent dose of prednisone within 28 days prior to random assignment.
- •Patients who were known to have hypersensitivity to any research drug or similar drug are not eligible.
- •Patients received local treatments such as pre-focal treatment,radiotherapy and palliative endoscopic resection
- •Patients with severe or uncontrolled concurrent infections are not eligible.
- •Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
- •Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
- •Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
- •Patients with mental illness, mental disability or inability to give informed consent are not eligible.
研究组 & 干预措施
Docetaxel plus platinum
Docetaxel combined with platinum-based drugs will be applied every 3 weeks for 6 cycles.
干预措施: Docetaxel (Drug)
Docetaxel plus platinum
Docetaxel combined with platinum-based drugs will be applied every 3 weeks for 6 cycles.
干预措施: Prednisolone Acetate (Drug)
Docetaxel plus platinum
Docetaxel combined with platinum-based drugs will be applied every 3 weeks for 6 cycles.
干预措施: Platinum-based drugs (Drug)
Docetaxel alone
Docetaxel alone will be applied every 3 weeks for 6 cycles.
干预措施: Docetaxel (Drug)
Docetaxel alone
Docetaxel alone will be applied every 3 weeks for 6 cycles.
干预措施: Prednisolone Acetate (Drug)
结局指标
主要结局
Time to Metastatic Castration-Resistant Prostate Cancer (mCRPC)
时间窗: up to 3 years
Time from treatment initiation to Metastatic Castration-Resistant Prostate Cancer (mCRPC). Patients with metastatic prostate cancer develop PCa progression during androgen deprivation therapy (or after bilateral orchiectomy), meet any of the following criteria was defined as mCRPC. 1)PSA progression (defined as elevated PSA levels(≥1ng/ml) for no less than 2 measurements at least 1 week apart); 2) Radiographic progression in soft tissues, with or without PSA progression, according to RECIST 1.1 criteria; 3) Bone progression (defined as 2 or more new bone lesions on bone scans) with or without PSA progression, according to PCWG.
次要结局
- Time to subsequent anti-tumor therapy(up to 5 years)
- Overall survival(up to 5 years)
- rPFS(up to 5 years)
- Time to PSA progression(up to 5 years)
- Adverse events(up to 3 years)
研究者
Hongqian Guo
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School