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
- Conditions
- Prostate cancer10038588
- Registration Number
- NL-OMON46625
- Lead Sponsor
- Pantarhei Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
- 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 and 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 year.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The first primary outcome parameter in this study is to assess the effect of E4<br /><br>on total testosterone and free testosterone levels.<br /><br>The second primary parameter is to assess the effects of E4 on hot flushes. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome parameters are:<br /><br>• To assess the effects of E4 on endocrine parameters, adrenal androgens, DHT<br /><br>and SHBG;<br /><br>• To assess the PSA response;<br /><br>• To assess the effects of E4 on health related quality of life;<br /><br>• To assess the effects of E4 on the lipid profile;<br /><br>• To assess the effects of E4 on bone turnover;<br /><br>• To assess the safety and tolerability of the E4 treatment.</p><br>