A Phase II Trial to Assess the Effect of Cinacalcet Hydrochloride on PSA Levels in Patients With Biochemically Recurrent Prostate Cancer After Failed Definitive Local Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of Rise of Serum PSA
研究概览
简要总结
This phase II trial is studying how well cinacalcet hydrochloride works in treating men with recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment
详细描述
PRIMARY OBJECTIVES:
I. To test the hypothesis that once-daily treatment with 30 mg of cinacalcet hydrochloride (Sensipar) will reduce the rate of rise of serum prostate-specific antigen (PSA) compared to pre-treatment PSA values in subjects with biochemically recurrent prostate cancer after failed definitive local therapy.
OUTLINE:
Patients receive cinacalcet hydrochloride orally (PO) once daily (QD) for 20 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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
- •Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate
- •For patients who have recurrent disease following surgery as first line therapy ("surgical failures")
- •PSA requirement is 0.2 ng/ml or above
- •For patients who have recurrent disease following radiation as first line therapy, the eligibility follows the "Phoenix criteria", that is, a rise of 2 ng/mL over the PSA nadir
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Granulocytes >= 1000/uL
- •Serum creatinine =< 2.0 mg/dl
- •Total serum calcium > 9.0 and < 10.5 mg/dl
- •Total bilirubin =< 2.0 mg/dl
- •Platelet count >=100,000/uL
- •Hemoglobin (Hgb) >= 9 g/dL
- •Total testosterone >= 50 ng/dL
- •Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)
排除标准
- •Serious medical illness which would limit survival to less than 3 months
- •Active, uncontrolled bacterial, viral or fungal infection
- •Hemorrhagic disorder
- •Any radiographic evidence of metastatic disease including positive bone scan or computed tomography (CT) abdomen/pelvis
- •History of hypocalcemia or seizure disorder
- •Patients with known hypersensitivity to any of the components of cinacalcet (cinacalcet hydrochloride)
研究组 & 干预措施
Treatment (cinacalcet hydrochloride)
Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Treatment (cinacalcet hydrochloride)
Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: quality-of-life assessment (Procedure)
Treatment (cinacalcet hydrochloride)
Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
Treatment (cinacalcet hydrochloride)
Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: cinacalcet hydrochloride (Drug)
结局指标
主要结局
Rate of Rise of Serum PSA
时间窗: 24 weeks
The difference of post treatment and pre-enrollment PSA.For those with multiple PSA measures post we use the median of those measures to estimate the participant's post PSA level.
次要结局
- Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P)(up to 20 weeks)
- Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory(Up to 20 weeks)
- Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC)(up to 20 weeks)
- Change in Total and Free Testosterone(Up to 20 weeks)