A Single-center, Phase II Neoadjuvant Study of Abiraterone Acetate in the Treatment of Intraductal Carcinoma of the Prostate
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response Rate（pCR）
研究概览
简要总结
Neoadjuvant treatment before radical prostatectomy has been proven to provide benefits on peri-operation results, especially on reduction of tumor volume and minimization of biochemical recurrence. This study will evaluate the efficacy and safety of abiraterone acetate Plus androgen deprivation therapy（ADT）in high-risk localized prostate cancer with intraductal carcinoma of the prostate（IDC-P）.
详细描述
IDC-P is an adverse pathological entity of prostate cancer, characterized by the growth of malignant cells in pre-existing prostatic ducts and acini, and is present in high-grade disease and associated with poor prognosis. Previous studies have shown that IDC-P was significantly associated with an adverse clinical course in patients who received radical prostatectomy or radiotherapy, and the presence of IDC-P on the biopsy specimen was associated with a poor prognosis in terms of overall survival (OS) and a poor docetaxel response in patients with distant metastasis at the initial diagnosis. Our previous researches as well as other published data indicated that abiraterone had a better therapeutic efficacy than docetaxel as the first-line therapy in metastatic castration resistance prostate cancer（mCRPC）with IDC-P. Therefore we intended to perform this single-arm phase II clinical trial to evaluate the initial efficacy and safety of abiraterone acetate Plus ADT as neoadjuvant therapy for high-risk localized prostate cancer with IDC-P. The primary endpoint is the pathologic complete response (pCR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years
- •Histologically or cytologically diagnosis of prostate cancer with positive IDC-P status
- •High-risk localized prostate cancer, defined by either: Tumor stage ≥T3a by digital rectal examination, or Primary tumor Gleason score ≥ 8, or PSA > 20 ng/mL
- •No evidence of metastases
- •The ECOG score of the patient is ≤2
- •Expected survival over 5 years
- •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
- •Agree to collect the tumor tissue and blood samples needed for the research and apply them to related study
- •Adequate hematologic, renal and hepatic function:
- •Absolute neutrophil count [ANC] ≥1.5 x 10^9/L
- •Platelet count [PLT] ≥100 x 10^9/L
- •Hemoglobin [HGB] ≥9 g/dL
- •Serum Total bilirubin [TBIL] ≤1.5 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 2.5 x ULN
- •Serum albumin [ALB] ≥2.8 g/dL
- •Serum Creatinine ≤ 1.5 x ULN
- •Creatinine Clearance ≥ 40 mL/min
排除标准
- •Prior androgen deprivation therapy (medical or surgical), radiation therapy or chemotherapy for prostate cancer
- •Evidence of metastatic disease (M1) on imaging studies
- •Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
- •Major surgery or severe trauma within 30 days before enrollment
- •Patients with severe or uncontrolled concurrent，including but not limited to：
- •Severe or uncontrolled concurrent infections
- •Human immunodeficiency virus [HIV] infection positive
- •Suffer from acute or chronic active hepatitis B (HBsAg positive and HBV DNA>1x10^3/mL) Or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA>15 IU/mL)
- •Active tuberculosis, etc
- •Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure，or clinically significant ventricular arrhythmias
- •Uncontrolled hypertension（Systolic blood pressure≥160mmHg or Diastolic blood pressure≥100mmHg）
- •Severe or unstable angina, myocardial infarction，arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks) Occurred within 6 months before enrollment
- •Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
- •Any condition that in the opinion of the investigator, would preclude participation in this study
研究组 & 干预措施
ADT with Abiraterone and prednisone
All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus abiraterone acetate and prednisone, as per standard of care. Goserelin 10.8 mg will be used once per 12 weeks. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone once per day. Subjects will continue to take abiraterone acetate and prednisone for 24 weeks before radical prostatectomy
干预措施: Abiraterone acetate (Drug)
ADT with Abiraterone and prednisone
All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus abiraterone acetate and prednisone, as per standard of care. Goserelin 10.8 mg will be used once per 12 weeks. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone once per day. Subjects will continue to take abiraterone acetate and prednisone for 24 weeks before radical prostatectomy
干预措施: Prednisolone (Drug)
ADT with Abiraterone and prednisone
All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus abiraterone acetate and prednisone, as per standard of care. Goserelin 10.8 mg will be used once per 12 weeks. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone once per day. Subjects will continue to take abiraterone acetate and prednisone for 24 weeks before radical prostatectomy
干预措施: Goserelin (Drug)
结局指标
主要结局
Pathologic Complete Response Rate（pCR）
时间窗: 6 months
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
次要结局
- Rate of Subjects With Minimal Residual Disease(6 months)
- Rate of positive surgical margin (PSM)(6 months)
- Rate of Nodal Metastases After 6 Months of Treatment(6 months)
- Rate of Pathologic T3 Disease After 6 Months of Treatment(6 months)
- Biochemical Progression-free Survival (bPFS)(2 years)
- PSA decline rate(6 months)
- Incidence and severity of adverse events(6 months)
- Quality of life (QOL) as assessed by FACT-P(Up to 24 months after surgery)
- Quality of life as assessed by EQ-5D(Up to 24 months after surgery)
- Radiographic progression-free survival (rPFS)(2 years)
- Overall survival(5 years)
研究者
Hao Zeng
Professor of Department of Urology
West China Hospital