Efficacy and Safety of Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: A Prospective, Multi-centre Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- 3-year biochemical progression-free survival
研究概览
简要总结
To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or rezvilutamide in combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years, male.
- •Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
- •pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
- •Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
- •Biochemical recurrence (two consecutive rises in PSA with absolute values > 0.2ng/ml, the time interval ≥ 2 weeks apart ) and no local recurrence or distant metastatic lesions on conventional imaging (bone scan and CT/MRI scan);
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- •Estimated life expectancy >10 year;
- •Adequate laboratory parameters
- •Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L
- •Platelet count (PLT) ≥ 100 x 10^9/L
- •Haemoglobin (Hb) ≥ 90 g/L
- •Serum creatinine (Cr) ≤ 1.5 x upper limit of normal(ULN) or creatinine clearance > 50 ml/min.
- •Total bilirubin (TBIL) ≤ 1.5 x ULN.
- •Glutamic oxaloacetic transaminase (AST/SGOT) or glutamic alanine transaminase (ALT/SGPT) levels ≤ 2.5 x ULN.
- •International normalised ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5 x ULN .
- •Left ventricular ejection fraction (LVEF) ≥ 50%.
- •Patients able to comply with the protocol. Arm 1 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy.
- •Signed informed consent.
排除标准
- •Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
- •Postoperative biochemical recurrence with PSA > 2 ng/ml.
- •Postoperative pathology containing neuro-endocrine differentiation or small cell features.
- •Prior malignancy other than prostate cancer in the past three years.
- •History of any of the following:
- •Seizure or known condition that may pre-dispose to seizure
- •Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to entry.
- •Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)
- •Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.
研究组 & 干预措施
Rezvilutamide +ADT
Rezvilutamide along with ADT for 12 cycles (28 days for each cycle)
干预措施: Rezvilutamide (Drug)
Rezvilutamide +ADT
Rezvilutamide along with ADT for 12 cycles (28 days for each cycle)
干预措施: Androgen deprivation therapy (ADT) (Drug)
Rezvilutamide +ADT+ SRT
Rezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care
干预措施: Rezvilutamide (Drug)
Rezvilutamide +ADT+ SRT
Rezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care
干预措施: Androgen deprivation therapy (ADT) (Drug)
Rezvilutamide +ADT+ SRT
Rezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care
干预措施: SRT (Radiation)
结局指标
主要结局
3-year biochemical progression-free survival
时间窗: 36 months
For arm 2, biochemical progression is defined as a confirmed PSA greater than (\>) 0.2 ng/ml( the time interval should be over 2 weeks)
2-year biochemical progression-free survival
时间窗: 24 months
For arm 1, biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (\>) 0.2 nanogram per milliliter (ng/ml)
次要结局
- Time to testosterone recovery to >50 ng/dl(36 months)
- Time to testosterone recovery to >300 ng/dl(36 months)
- progression-free survival (PFS)(36 months)
- biochemical progression-free survival(36 months)
- metastasis-free survival (MFS)(36 months)
- Quality of life as determined by EPIC-26 questionnaire(At baseline, 3 months, 6 months, every 3 months up to 3 years)
- Number of Adverse Events(36 months)
- Duration of testosterone recovery(36 months)
- Quality of life as determined by FACT-P scores(At baseline, 3 months, 6 months, every 3 months up to 3 years)
研究者
Hongqian Guo
Chief physician of Department of Urology
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School