A Randomized, Controlled, Single Center Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Androgen Deprivation Therapy Combined With Docetaxel for High Risk and Very High Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response Rate
研究概览
简要总结
This randomized, controlled, single center clinical trial aims to evaluate the efficacy and safety of Androgen Deprivation Therapy Combined with Docetaxel for High Risk Prostate Cancer with a six-month treatment cycle.
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
- 18 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 ≥ 18 and ≤75 years of age.
- •All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
- •All patients must undergo thorough tumor staging and meet one of the following criteria:
- •multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3,
- •Gleason score of primary tumor ≥ 8, 3.prostate specific antigen (PSA) ≥20 ng/ml.
- •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 ≥ 9 g / 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 prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible.
- •Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3, Gleason score of primary tumor < 8, and prostate specific antigen (PSA) <20 ng/ml.
- •Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible.
- •Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy are not eligible.
- •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
Androgen Deprivation Therapy with Docetaxel
All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished.
干预措施: Docetaxel injection (Drug)
Androgen Deprivation Therapy with Docetaxel
All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished.
干预措施: Triptorelin Pamoate for Injectable Suspension (Drug)
Androgen Deprivation Therapy with Docetaxel
All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished.
干预措施: Prednisone Acetate Tablets (Drug)
ADT alone
All subjects in this arm will receive LHRHa alone for 24 weeks before receiving robot assisted radical prostatectomy. Triptorelin Pamoate 15mg will be administered once per 12 weeks.
干预措施: Triptorelin Pamoate for Injectable Suspension (Drug)
结局指标
主要结局
Pathologic Complete Response Rate
时间窗: up to 8 months
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
pCR or MRD rate
时间窗: up to 8 months
The proportion of patients with pCR or MRD. Pathologic complete response (pCR): defined as no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy. Minimal Residual Disease (MRD): defined as residual tumors with maximum diameter of 3 mm or less after radical prostatectomy.
次要结局
- Operative time (min)(12 month)
- biochemical progression-free survival (bPFS)(3 years)
- Imaging Response Rate(up to 8 months)
- Serum complete response rate(after 6 month neoadjuvant therapy and before surgery)
- Rate of extracapsular extension(12 month)
- Rate of Stage Degradation(up to 8 months)
- Rate of Complete Serum Remission(up to 8 months)
- Estimated blood loss (ml)(12 month)
- Hospital length of stay (day)(12 month)
- Drainage duration (day)(12 month)
- Recovery time of urinary continence (day)(12 month)
- metastasis-free survival (MFS)(5 years)
- Incidence of complications (%)(12 month)
- Rate of positive lymph node(12 month)
- Rate of Positive Surgical Margins(up to 8 months)
研究者
Hongqian Guo
chief physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School