Neoadjuvant Treatment of Prostate Cancer With Bicalutamide and Raloxifene Prior to Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Collection and interrogation of prostate cancer samples
研究概览
简要总结
This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the body.
详细描述
PRIMARY OBJECTIVES:
I. To collect and interrogate samples in patients with prostate cancer that were diagnosed with prostate cancer and are planned for radical prostatectomy at Mayo Clinic Arizona.
SECONDARY OBJECTIVES:
I. To describe the adverse event profile and tolerance of therapy for 60 days of treatment prior to surgery.
II. To assess change in stage and/or grade of cancer and prostate specific antigen (PSA) response to neoadjuvant treatment in patients with hormone sensitive 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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of adenocarcinoma of the prostate, >= Gleason 6, clinical stage T1a-T2c and planned for radical prostatectomy
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •Platelet count >= 50,000/mm^3
- •Hemoglobin > 9.0 g/dL
- •Creatinine =< 2.0 mg/dL
- •Provide informed written consent
- •Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study); Note: during the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
- •Patients must also provide written consent for biospecimens collection on Institutional Review Board (IRB) 08-000980
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- •History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- •History of a venous thromboembolic event, cerebrovascular accident (CVA), hepatic impairment, or heart failure
研究组 & 干预措施
Arm A (raloxifene hydrochloride)
Patients receive low dose raloxifene hydrochloride PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Arm A (raloxifene hydrochloride)
Patients receive low dose raloxifene hydrochloride PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm A (raloxifene hydrochloride)
Patients receive low dose raloxifene hydrochloride PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Raloxifene Hydrochloride (Drug)
Arm B (bicalutamide)
Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Bicalutamide (Drug)
Arm B (bicalutamide)
Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Arm B (bicalutamide)
Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm C (raloxifene hydrochloride, bicalutamide)
Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Bicalutamide (Drug)
Arm C (raloxifene hydrochloride, bicalutamide)
Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Arm C (raloxifene hydrochloride, bicalutamide)
Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm C (raloxifene hydrochloride, bicalutamide)
Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Raloxifene Hydrochloride (Drug)
Arm D (raloxifene hydrochloride, bicalutamide)
Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Bicalutamide (Drug)
Arm D (raloxifene hydrochloride, bicalutamide)
Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Arm D (raloxifene hydrochloride, bicalutamide)
Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm D (raloxifene hydrochloride, bicalutamide)
Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Raloxifene Hydrochloride (Drug)
结局指标
主要结局
Collection and interrogation of prostate cancer samples
时间窗: Up to 5 years
Pathways and biomarkers will be compared to similar analyses that have been and will be performed on in vitro and in vivo experiments. Point estimates and two-sided 95% confidence intervals will be computed.
次要结局
- Change in cancer stage/grade via surgical pathology(Baseline up to the time of prostatectomy)
- Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0(Up to 30 days)
- Percent change in PSA assessed by Prostate Cancer Clinical Trials Working Group(Baseline up to 12 weeks)
- Tolerance of therapy(Up to 60 days)