A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- PSA Progression
研究概览
简要总结
This study is being offered to patients who have hormone resistant prostate cancer (HRPC). This means that their prostate cancer is no longer responding to standard hormonal therapy.
The purpose of this study is to determine whether Degarelix will be able to stop the PSA from rising in patients with hormone resistant prostate cancer.
详细描述
This is a phase II study of a GnRH antagonist drug, Degarelix, for use in hormone resistant prostate cancer patients who have had biochemical PSA progression despite the use of total androgen blockade therapy. Patients will receive at least six monthly injections of Degarelix unless the patient shows radiographic or symptomatic disease progression, intolerable toxicity or decides to withdraw from the study. Patients will be evaluated for measures of efficacy, toxicity and disease progression during treatment and afterwards until radiologically confirmed metastatic disease progression or until the patient is removed from the study.
Overall objective:
The efficacy of Degarelix as a treatment for HRPC will be evaluated
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
- •Prior trial of total androgen blockade
- •Confirmed biochemical PSA progression on agonist therapy, defined as ≥ 50% increase in PSA between 2 measurements, taken at least 1 week apart. In patients that are currently on total androgen blockade (LHRH agonist plus non-steroidal anti-androgen) there must be a trial withdrawal of androgen receptor antagonists to ensure that there is no PSA response (6 weeks for bicalutamide and 4 weeks for flutamide or nilutamide).
- •Radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, CT Scan Abdomen/Pelvis and Bone scan
- •Age ≥ 18 years
- •Serum testosterone of ≤ 50 mg/dl
- •PSA ≥ 2.0 ng/ml
- •White blood cell count ≥ 3000/mm3
- •Platelets ≥ 100,000/mm3
- •Serum creatinine ≤ 1.5 x upper limits of normal
- •Bilirubin ≤ 1.5 x upper limits of normal
- •Alanine transaminase ≤ 1.25 x upper limits of normal
- •Estimated life expectancy of at least 12 months
- •Able and willing to sign informed consent
排除标准
- •Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, PC-SPES, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or Androcur)
- •Known allergy to GnRH agonists or antagonists
- •Previous treatment with Degarelix
- •Major surgery within 4 weeks of registration
- •Grade ≥ 3 peripheral neuropathy
- •Severe, active co-morbidity such as unstable angina, congestive heart failure or myocardial infarction within the last 6 months or congenital long QT syndrome
- •Acute deep vein thrombosis or pulmonary embolism
- •Taking anti-arrhythmia medication
- •Second malignancy other than non-melanoma skin cancer unless disease free ≥ 5 years.
- •Prior orchiectomy for prostate cancer
- •PSA > 100 ng/mL
研究组 & 干预措施
Degarelix
Degarelix treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.
干预措施: Degarelix (Drug)
结局指标
主要结局
PSA Progression
时间窗: Monthly for 6 months then every 3 months
Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal
次要结局
- Time to Disease progression(Monthly for 6 months then every 3 months)
- The efficacy of Testosterone, LH and FSH suppression with Degarelix(Monthly for 6 months then every 3 months)
- The impact of monthly injections of Degarelix on Health Related Quality of Life Issues in patients with prostate cancer(Month 3 and 6 then every 3 months)