Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response
研究概览
简要总结
Pembrolizumab will be administered at a dose of 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Enzalutamide will be administered at dose of 160 mg orally every day. All patients will be required to have at least one high-risk criteria.
详细描述
The investigators propose to study the effects of pembrolizumab combined with intensive androgen receptor (AR) targeting prior to prostatectomy with extended pelvic lymph node dissection in subjects with high-risk localized prostate cancer (HRLPC).
Trial Design- single arm, single-stage, open label Phase II of neoadjuvant immune-hormonal therapy in high-risk localized prostate cancer.
Objectives To evaluate efficacy and safety of pembrolizumab combined with intensive AR targeting prior to prostatectomy in subjects with high-risk localized prostate cancer (HRLPC).
Primary Endpoint Pathologic complete response (pCR) defined as absence of detectable malignant cells in the prostatectomy specimen evaluated by standard histologic techniques.
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
- •Be willing and able to provide written informed consent/assent for the trial.
- •Capability to understand and comply with the protocol and signed informed consent document.
- •Be ≥ 18 years of age on day of signing informed consent.
- •Have measurable disease based on RECIST 1.
- •Histologically confirmed, non-metastatic adenocarcinoma of the prostate
- •Prostatectomy with extended lymph node dissection planned as primary therapy
- •10 year or longer life expectancy based on other co-morbidities
- •Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- •Any one of the following three high risk features:
- •Gleason grade > 8-10
- •PSA > 20 ng/ml
- •Clinical stage T3a (resectable)
- •No evidence of metastases .
- •No other diagnosis of malignancy (with exception of non-melanoma skin cancer or a malignancy diagnosed ≥5 years ago).
- •Male subjects of childbearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through the time of surgery. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- •Demonstrate adequate organ function, all screening labs should be performed within 30 days of treatment initiation.
排除标准
- 未提供
研究组 & 干预措施
Intervention
Treatment will be planned for a total of 14 to 16 weeks. Pembrolizumab will be administered every 3 weeks via IV infusion with a dose of 200 mg per infusion. Enzalutamide will be given orally and dispensed to the patient on the date of their first infusion. The dosage of Enzalutamide will be 160 mg, administered once daily for approx. 16 weeks. GNRH agonist therapy will be administered as a standard of care therapy and will follow a standard dosage to maintain castrate levels.
干预措施: Pembrolizumab (Drug)
Intervention
Treatment will be planned for a total of 14 to 16 weeks. Pembrolizumab will be administered every 3 weeks via IV infusion with a dose of 200 mg per infusion. Enzalutamide will be given orally and dispensed to the patient on the date of their first infusion. The dosage of Enzalutamide will be 160 mg, administered once daily for approx. 16 weeks. GNRH agonist therapy will be administered as a standard of care therapy and will follow a standard dosage to maintain castrate levels.
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Pathologic Complete Response
时间窗: 4 months
No cancer detected on pathology examination of prostatectomy specimen
次要结局
- Treatment Related Adverse Events(4 months + 30 days)
- Immune -related Adverse Events(4 months + 30 days)
- Biochemical Complete Response(4 months)
- Incidence of Surgical Complications(4 months)
研究者
Mark Garzotto, MD
Director of Urologic Oncology
Portland VA Medical Center