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.
Overview
- Phase
- Phase 2
- Intervention
- Estetrol
- Conditions
- Prostatic Neoplasm
- Sponsor
- Pantarhei Oncology B.V.
- Enrollment
- 63
- Locations
- 6
- Primary Endpoint
- Difference in total testosterone levels between treatment groups
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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 ≤ 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.
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;
Arms & Interventions
estetrol
Intervention: Estetrol
placebo
Intervention: Placebo Oral Tablet
Outcomes
Primary Outcomes
Difference in total testosterone levels between treatment groups
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)