A Randomized, Controlled, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Time to PSA progression progression
研究概览
简要总结
This randomized, controlled, multi-center clinical trial aims to evaluate the efficacy and safety of prostatectomy for castration-Naive oligometastatic 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
- 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 a histologically or cytologically diagnosis of prostate cancer.
- •All patients must have been diagnosed oligometastatic prostate cancer which meet the following criteria. (1) ≤5 metastatic lesions are found by imaging examination (2)No visceral metastasis was found (3) The diameter of a single lesion ≤5cm or the surface area ≤250cm
- •Patients previously treated with surgical castration or androgen deprivation therapy must maintain a testosterone level of <50ng/dl or <1.7nmol/L during treatment. Also the treatment duration should be less than 9 months. Patients were previously treated with at least 6 cycles of abiraterone.
- •PSA<2ng/ml before enrollment.
- •There was no PSA progression or radiographic progression during previous treatment.
- •Primary lesion must be eligible for radical prostatectomy based on random radiographic assessment. ( Preoperative clinical staging <T4 or achievable complete resection agreed by experienced surgeons is deemed as eligible for radical prostatectomy)
- •Eastern Cooperative Oncology Group (ECOG) physical condition score ≤
- •Patients must have adequate hematologic function, within 28 days prior to registration as evidenced by: white blood cell (WBC) ≥ 4.0 × 109 /L, platelets≥ 100 × 109 / L, hemoglobin ≥ 9g / dL, and international normalized ratio (INR) < 1.
- •Patients must have adequate hepatic function, within 28 days prior to registration, as evidenced by: total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN),and SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN.
- •Patients must have adequate renal function, within 28 days prior toregistration, as evidenced by serum creatinine ≤2×ULN
- •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.
排除标准
- •Patients with neuroendocrine, small cell, or signet ring cell histological features are not eligible.
- •Patients with visceral metastasis or more than 5 metastatic lesions are excluded.
- •Patients were diagnosed metastatic castration-naive prostate cancer for more than 9 months or showed biochemical or radiographic progression before enrollment.
- •Patients with unresectable primary lesion before enrollment based on CT/MRI.
- •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
ADT plus abiraterone + surgery
After 6 cycles of first-line treatment (Androgen deprivation therapy + abiraterone acetate along with prednisone) , patients will receive robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection (ePLND) within 9 months of being diagnosed. The ADT+abiraterone treatment will be maintained after surgery.
干预措施: robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection (Procedure)
ADT plus abiraterone + surgery
After 6 cycles of first-line treatment (Androgen deprivation therapy + abiraterone acetate along with prednisone) , patients will receive robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection (ePLND) within 9 months of being diagnosed. The ADT+abiraterone treatment will be maintained after surgery.
干预措施: 1.Abiraterone Acetate Tablets (Drug)
ADT plus abiraterone + surgery
After 6 cycles of first-line treatment (Androgen deprivation therapy + abiraterone acetate along with prednisone) , patients will receive robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection (ePLND) within 9 months of being diagnosed. The ADT+abiraterone treatment will be maintained after surgery.
干预措施: Prednisone Acetate Tablets (Drug)
ADT plus abiraterone + surgery
After 6 cycles of first-line treatment (Androgen deprivation therapy + abiraterone acetate along with prednisone) , patients will receive robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection (ePLND) within 9 months of being diagnosed. The ADT+abiraterone treatment will be maintained after surgery.
干预措施: Luteinizing Hormone-Releasing Hormone Analog (Drug)
ADT plus abiraterone
Patients will be only treated with Androgen deprivation therapy + abiraterone acetate along with prednisone. Prostatectomy won't be performed.
干预措施: 1.Abiraterone Acetate Tablets (Drug)
ADT plus abiraterone
Patients will be only treated with Androgen deprivation therapy + abiraterone acetate along with prednisone. Prostatectomy won't be performed.
干预措施: Prednisone Acetate Tablets (Drug)
ADT plus abiraterone
Patients will be only treated with Androgen deprivation therapy + abiraterone acetate along with prednisone. Prostatectomy won't be performed.
干预措施: Luteinizing Hormone-Releasing Hormone Analog (Drug)
结局指标
主要结局
Time to PSA progression progression
时间窗: up to 2 years
PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart.
Time to Radiographic progression
时间窗: up to 2 years
Radiographic progression is defined as newly discovered soft tissue metastasis according to the RECIST 1.1 or at least 2 bone lesions.
次要结局
- rPFS (radiographic progression free survival)(up to 2 years)
- Time to castration resistance(up to 2 years)
- Time to PSA remission (≥50%) and time to PSA remission (≥90%)(up to 2 years)
- Time to new anti-cancer treatment(up to 2 years)
研究者
Hongqian Guo
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School