Prostate cancer
Conditions
Interventions
Patients with prostate cancer, qualifying for hormonal castration therapy with
an LHRH agonist will be assigned to one of two treatment groups, either the
active (Group 1) or the placebo group (Grou
provided as two E4 tablets per day
Group 2: Placebo
provided as two placebo tablets per day
Patients will be treated for 24 weeks with the study medication.
The study will start with a screening (visit 1). At the screening a physical
examination wil
Sponsors
Pantarhei Oncology
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male patients with prostate cancer, qualifying for treatment with a LHRH agonist. - Age >=18 years; - Body mass index (BMI) between >= 18.0 and
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first primary outcome parameter in this study is to assess the effect of E4 on total testosterone and free testosterone levels. The second primary parameter is to assess the effects of E4 on hot flushes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are: • To assess the effects of E4 on endocrine parameters, adrenal androgens, DHT and SHBG; • To assess the PSA response; • To assess the effects of E4 on health related quality of life; • To assess the effects of E4 on the lipid profile; • To assess the effects of E4 on bone turnover; • To assess the safety and tolerability of the E4 treatment. | — |
Countries
Netherlands
Outcome results
None listed