A Double-blind, Randomised, Placebo-controlled, Multi-center Study to Evaluate Effects of Estetrol on Testosterone Suppression and Quality of Life in Prostate Cancer Patients Treated With an LHRH Agonist.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 6
- 主要终点
- Difference in total testosterone levels between treatment groups
研究概览
简要总结
This is a phase IIa, double-blind, randomised, placebo-controlled, multi-center study to evaluate the effects of estetrol on testosterone suppression and quality of life in prostate cancer patients treated with an LHRH agonist. Patients will be treated with estetrol or placebo for 6 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male patients with prostate cancer, qualifying for treatment with a LHRH agonist;
- •Age ≥ 18 years;
- •Body mass index (BMI) between ≥ 18.0 and ≤ 35.0 kg/m2 (inclusive);
- •Reasonable physical and mental health as judged by the Investigator determined by physical examination, clinical laboratory assessments and vital signs;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
- •Life expectancy of at least 2 years.
排除标准
- •Current or prior (during the last 12 months) hormonal therapy, immunotherapy or chemotherapy for prostate cancer. Allowed are 14 days concomitant treatment with an anti-androgen to prevent the flare-up, radiotherapy and low dose radiation to prevent gynecomastia;
- •History of deep vein thrombosis, pulmonary embolism, or cerebrovascular accident. However, patients with such history using anticoagulants for ≥ 6 months are eligible for the study provided anticoagulant treatment is continued throughout the whole study;
- •History of myocardial infarction or a coronary vascular procedure (e.g. percutaneous coronary intervention, coronary artery bypass graft). However, patients with such history using anticoagulants for ≥ 6 months are eligible for the study provided anticoagulant treatment is continued throughout the whole study;
- •Patients who have unstable angina or clinical congestive heart failure;
- •A defect in the blood coagulation system, assessed at screening: deficiencies in AT-III, protein C and protein S and elevated factor VIII;
- •Mutation in coagulation factor II and/or positive for factor V Leiden, assessed at screening;
- •Diabetes mellitus with poor glycaemic control in the past 6 months (haemoglobin A1c (HbA1c) above 7.5%);
- •Known primary hyperlipidaemias (Fredrickson);
- •Disturbance of liver function: cholestatic jaundice, a history of jaundice due to previous estrogen use, Rotor syndrome and Dubin-Johnson syndrome;
- •Known porphyria;
- •Uncontrolled hypertension, i.e. systolic blood pressure 160 mmHg and/or diastolic blood pressure 100 mmHg in the last 6 months with or without medication.
研究组 & 干预措施
estetrol
干预措施: Estetrol (Drug)
placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Difference in total testosterone levels between treatment groups
时间窗: 168 days
Serum concentrations of total testosterone will be listed and summarized descriptively by treatment group. Nadir and time to nadir will be described using summary statistics.
Difference in free testosterone levels between treatment groups
时间窗: 168 days
Serum concentrations of free testosterone will be listed and summarized descriptively by treatment group. Nadir and time to nadir will be described using summary statistics.
Difference in mean daily hot flushes score between treatment groups
时间窗: 168 days
The number and severity in hot flushes will be assessed by means of a diary in which the patients records his hot flushes for 7 days.
次要结局
- Change from baseline in prostate-specific antigen (PSA) response(168 days)
- Change from baseline in bone turnover markers(168 days)
- Change from baseline in endocrine parameters, adrenal androgen, dihydrotestosterone (DHT) and Sex Hormone Binding Globulin (SHBG)(168 days)
- Questionnaire on Quality of Life(168 days)
- Change from baseline in lipids(168 days)