A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- PSA Response
研究概览
简要总结
This is an open label, single center Phase II trial of Sandostatin LAR in patients with hormone refractory prostate cancer. Patients will receive Sandostatin LAR 30 mg intramuscularly every 28 days. Patients will be treated until the time of disease progression, unacceptable toxicity or withdrawal of consent. The study will require 27 evaluable patients.
详细描述
Primary Objective:
To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR.
Secondary Objective:
To evaluate the effects of Sandostatin LAR on circulating levels of Insulin Growth Factor-1 and Insulin Growth Factor Binding Protein 1.
To evaluate the safety of Sandostatin LAR in this patient population. To evaluate the pre versus post treatment mitogenic effects of serum derived from subjects with prostate cancer compared to pretreatment serum.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate.
- •Biochemical disease progression following androgen deprivation and therapy with at least one antiandrogen defined as three rises in PSA with PSA determinations at least 4 weeks apart and each PSA value > 0.2 ng/ml.
- •Four weeks since prior therapy with Flutamide.
- •Six weeks since prior therapy with Bicalutamide or Nilutamide.
- •Current PSA > 5 ng/ml.
- •Testosterone <50 ng/dL.
- •SGPT (ALT) < 1.5 times upper limit of normal.
- •Fasting blood glucose > 60 mg/dL.
- •ECOG performance status 0, 1 or
- •No visceral or bony metastatic disease (Lymph node only metastases are allowed).
- •No prior chemotherapy for prostate cancer.
- •No current treatment with insulin or an oral hypoglycemic.
- •No history of treatment with octreotide analogs for prostate cancer.
- •No NYHA Class 3 or 4 cardiac status.
排除标准
- •Diabetes Mellitus requiring medical therapy and/or that which is not controlled by dietary means (HbA1C<6.0).
- •A history of gallstones that has been clinically significant. Patients who have undergone cholecystectomy are eligible.
- •Other concomitant medical or psychiatric condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements.
- •Prior treatment with chemotherapy for prostate cancer.
- •No current treatment with Saw Palmetto, or Proscar. Patients must be off these medicines for more than 4 weeks.
研究组 & 干预措施
1
干预措施: Sandostatin (Drug)
结局指标
主要结局
PSA Response
时间窗: 12 weeks
Number of participants with a PSA decline of at least 50% from Baseline during the first 3 cycles of therapy, confirmed by a second measurement at least 2 weeks later.
次要结局
- Grade 4-5 Adverse Events(12 weeks)
- Pre Versus Post Treatment Mitogenic Effects.(12 Weeks)
- Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.(Baseline, 12 weeks)