Radiotherapy or Radical Prostatectomy Combined With Intense Androgen Deprivation Therapy for Newly Diagnosed Metastatic Prostate Cancer: A Multi-center Randomized Controlled Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Event-free Survival
研究概览
简要总结
This multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed prostate adenocarcinoma, with distant metastasis diagnosed by novel imaging modalities (PSMA PET/CT or PSMA PET/MR), involving ≤10 metastatic sites (amenable to local therapy) and without visceral metastasis.
- •The primary lesion is deemed resectable, or can achieve a resectable state following IADT.
- •Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months.
- •Eastern Cooperative Oncology Group (ECOG) physical condition score ≤
- •Patients must have adequate hematologic function, hepatic function and renal function.
- •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.
- •Fertile patients must be willing to use highly effective contraception during the study period.
排除标准
- •Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.
- •The researchers assessed the primary lesion as unresectable.
- •Patients who had previously received androgen deprivation therapy (including medical or surgical castration) for more than 3 months, or had undergone focal therapy for prostate cancer, or had received radiotherapy or chemotherapy for prostate cancer.
- •Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy.
- •Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina, or a history of myocardial infarction within the past 6 months.
- •Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent pulmonary disease, chronic liver disease, or HIV infection.
- •Within the past 5 years, having had other malignant tumors except for prostate cancer, with the exception of cured basal or squamous cell skin cancer.
- •Suffering from mental illness, mental disability, or being incapable of providing informed consent.
研究组 & 干预措施
Intense androgen deprivation therapy (IADT)
Patients received ADT plus ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years in the Intense androgen deprivation therapy (IADT) group.
干预措施: Intense androgen deprivation therapy (Drug)
Radiotherapy or Surgery plus IADT
For patients in the experimental group, local treatment either radiotherapy or surgery was arranged in addition to systemic ADT plus ARi. Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. While those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment.
干预措施: Intense androgen deprivation therapy (Drug)
Radiotherapy or Surgery plus IADT
For patients in the experimental group, local treatment either radiotherapy or surgery was arranged in addition to systemic ADT plus ARi. Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. While those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment.
干预措施: Radiation Therapy (Radiation)
Radiotherapy or Surgery plus IADT
For patients in the experimental group, local treatment either radiotherapy or surgery was arranged in addition to systemic ADT plus ARi. Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. While those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment.
干预措施: radical prostatectomy (Procedure)
结局指标
主要结局
Event-free Survival
时间窗: 2 years
Following 2 years of treatment, any anti-tumor treatment was terminated for those who met complete remission until two consecutively rised PSA\>0.2ng/ml. Complete remission is interpreted as PSA level\<0.1ng/ml and absence of radiographic as well as clinical progression following the 2-year treatment, both are indispensable. The primary outcome was event-free survival (EFS), defined as the time from disease complete remission to any required anti-tumor treatment.
次要结局
- progression-free survival(4 years)
- Time to CRPC(4 years)
- Adverse events(4 years)
研究者
Hongqian Guo
Chief physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School