A Phase II Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To assess the effects of combined neoadjuvant hormone therapy (NHT) and OGX-011 prior to radical prostatectomy on pathologic complete response rates in men with high risk localized prostate cancer
研究概览
简要总结
The purpose of this trial is to assess the effects of combined therapy with androgen ablation and OGX-011 (an antisense to clusterin) given prior to radical prostatectomy on pathologic complete response rates in men with localized prostate cancer and high risk features.
详细描述
Clusterin as an anti-apoptotic cytoprotective chaperone protein upregulated in an adaptive cell survival manner that confers resistance to various cell death triggers, including hormone-, radiation-, and chemotherapy. In pre-clinical models, inhibition of clusterin expression using the second generation antisense OGX-011 can enhance cell death following treatment with androgen ablation, radiotherapy, and chemotherapy. In phase I clinical trials, OGX-011 has been well tolerated and a biologically effective dose has been identified in humans.
Study Design
This is an open-label, non-blinded, phase II clinical, tissue pharmacokinetic and pharmacodynamic study of weekly OGX-011 and neoadjuvant hormone therapy prior to radical prostatectomy in patients with localized prostate carcinoma and high-risk features.
Study Objectives
Primary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically confirmed adenocarcinoma of the prostate, previously untreated
- •Males ≥ 18 years of age.
- •Potential candidate for radical prostatectomy
- •Any of the following (minimum of 2 positive biopsies):
- •Clinical stage T3
- •Serum PSA > 10 ng/ml
- •Gleason score 7-10
- •Gleason score 6 and > 3 positive biopsies
- •ECOG performance status 0-1
- •WBC ≥ 3.0 x 10^9/L
- •Hemoglobin ≥ 100 g/L
- •Platelets ≥ 100 x 10^9/L
- •PTT, INR, AST, ALT, creatinine, total bilirubin within normal limits
- •Patients must sign an informed consent that complies with US Regulations (US 21 Code of Federal Regulations [CFR]) and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) prior to undergoing treatment.
排除标准
- •Prior hormone, radiation, or chemotherapy for prostate cancer
- •Evidence of active infection
- •Patients receiving therapeutic doses of warfarin or heparin
- •Severe end organ disease
- •Patients who otherwise would not be candidates for radical prostatectomy because of health or tumour factors
- •Patients will be excluded if they had any prior malignancy unless the prior malignancy was diagnosed and definitively treated at least five years previously and there has never been any evidence of recurrence.
- •Other serious illness, psychiatric, or medical condition that would not permit the patient to be managed according to the protocol.
结局指标
主要结局
To assess the effects of combined neoadjuvant hormone therapy (NHT) and OGX-011 prior to radical prostatectomy on pathologic complete response rates in men with high risk localized prostate cancer
时间窗: See Detailed Description, Treatment Plan
次要结局
- To assess the safety and tolerability toxicity of 3 months of OGX-011 and NHT prior to radical prostatectomy(See Detailed Description, Treatment Plan)
- To measure evidence of OGX-011's effect on patient clusterin serum levels(See Detailed Description, Treatment Plan)
- To measure levels of full length OGX-011 in prostate tissues after 3 months of NHT(See Detailed Description, Treatment Plan)
- To assess the effects of combined NHT and OGX-011 on time to prostate specific antigen (PSA) nadir(See Detailed Description, Treatment Plan)
- To quantify changes in clusterin expression in residual prostate cancer after treatment with NHT and OGX-011(See Detailed Description, Treatment Plan)
- To measure evidence of OGX-011's effect on clusterin expression in patient peripheral blood mononuclear cells (PBMNC)(See Detailed Description, Treatment Plan)
- To determine PSA recurrence rates after combined NHT and OGX-011(See Detailed Description, Treatment Plan)