A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- 3 year biochemical progression free survival (bPFS)
研究概览
简要总结
This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.
详细描述
The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.
- •All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET/CT shows clinical staging of primary tumor ≥ T3; b) Gleason score of primary tumor ≥ 8; c)prostate specific antigen(PSA) ≥20 ng/ml; d) Imaging evaluation shows regional lymph node metastases (N1).
- •Eastern Cooperative Oncology Group (ECOG) physical condition score ≤
- •Patients must have adequate hematologic function, hepatic function, renal function and cardiac 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 bewilling 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 and within 120 days of the last dose of treatment.
排除标准
- •Patients with neuroendocrine, small cell, or sarcoma-like pathologic features are not eligible.
- •Patients with low-risk or medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: a) multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3; b) Gleason score of primary tumor < 8; c) 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 (any M1) are not eligible.
- •Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment, radiotherapy, chemotherapy for prostate cancer 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
ADT plus Abiraterone
A total of 150 subjects in this group received abiraterone acetate + prednisolone acetate daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Prednisolone tablets (Drug)
ADT plus Darotamide
A total of 150 subjects in this group received darotamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Darotamide (Drug)
ADT alone + prostatectomy
A total of 100 subjects receive ADT for 6 cycles (28 days per cycle) before prostatectomy. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: ADT (Drug)
ADT alone + prostatectomy
A total of 100 subjects receive ADT for 6 cycles (28 days per cycle) before prostatectomy. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Robot-assisted radical prostatectomy (Procedure)
ADT plus Abiraterone
A total of 150 subjects in this group received abiraterone acetate + prednisolone acetate daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: ADT (Drug)
ADT plus Abiraterone
A total of 150 subjects in this group received abiraterone acetate + prednisolone acetate daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Abiraterone Acetate (Drug)
ADT plus Abiraterone
A total of 150 subjects in this group received abiraterone acetate + prednisolone acetate daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Robot-assisted radical prostatectomy (Procedure)
ADT plus Enzalutamide
A total of 50 subjects in this group received enzalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: ADT (Drug)
ADT plus Enzalutamide
A total of 50 subjects in this group received enzalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Enzalutamide (Drug)
ADT plus Enzalutamide
A total of 50 subjects in this group received enzalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Robot-assisted radical prostatectomy (Procedure)
ADT plus Apalutamide
A total of 150 subjects in this group received apalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: ADT (Drug)
ADT plus Apalutamide
A total of 150 subjects in this group received apalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Apalutamide (Drug)
ADT plus Apalutamide
A total of 150 subjects in this group received apalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Robot-assisted radical prostatectomy (Procedure)
ADT plus Darotamide
A total of 150 subjects in this group received darotamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: ADT (Drug)
ADT plus Darotamide
A total of 150 subjects in this group received darotamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Robot-assisted radical prostatectomy (Procedure)
ADT plus Rizvilutamide
A total of 150 subjects in this group received rizvilutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: ADT (Drug)
ADT plus Rizvilutamide
A total of 150 subjects in this group received rizvilutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Rezvilutamide (Drug)
ADT plus Rizvilutamide
A total of 150 subjects in this group received rizvilutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Robot-assisted radical prostatectomy (Procedure)
PARP inhibitor + abiraterone + ADT
A total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: ADT (Drug)
PARP inhibitor + abiraterone + ADT
A total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Abiraterone Acetate (Drug)
PARP inhibitor + abiraterone + ADT
A total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Prednisolone tablets (Drug)
PARP inhibitor + abiraterone + ADT
A total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: PARP inhibitor (Drug)
PARP inhibitor + abiraterone + ADT
A total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Robot-assisted radical prostatectomy (Procedure)
PARP inhibitor + ADT
A total of 50 subjects in this group in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor along with ADT mentioned above. Enrolled patients carry homologous recombination repair (HRR) gene mutation verified by molecular testing. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: ADT (Drug)
PARP inhibitor + ADT
A total of 50 subjects in this group in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor along with ADT mentioned above. Enrolled patients carry homologous recombination repair (HRR) gene mutation verified by molecular testing. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: PARP inhibitor (Drug)
PARP inhibitor + ADT
A total of 50 subjects in this group in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor along with ADT mentioned above. Enrolled patients carry homologous recombination repair (HRR) gene mutation verified by molecular testing. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
干预措施: Robot-assisted radical prostatectomy (Procedure)
结局指标
主要结局
3 year biochemical progression free survival (bPFS)
时间窗: up to 3 years
Biochemical progression free survival (bPFS) within 3 years
Pathologic response rate
时间窗: up to 3 years
Pathologic response rate= Pathologic Complete Response (pCR) Rate + Minimal Residual Disease (MRD) rate
次要结局
- Metastasis-Free Survival (MFS)(up to 5 years)
- PSA response rate(up to 3 years)
- Positive margin rate(up to 6 months)
- Time to castration-resistant prostate cancer（CRPC)(up to 5 years)
- Pathologic downgrade rate(up to 6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 5 years)
研究者
Hongqian Guo
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School