Status:
COMPLETED
Evaluation of Effects of Estetrol on Testosterone Suppression and Quality of Life in Prostate Cancer Patients Treated With an LHRH Agonist.
Lead Sponsor:
Pantarhei Oncology B.V.
Conditions:
Prostatic Neoplasm
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2020
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03361969
Start Date
April 16 2018
End Date
May 15 2020
Last Update
June 18 2021
Active Locations (6)
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1
Andros Men's Health Institutes
Arnhem, Gelderland, Netherlands, 6803 AA
2
Noord West Ziekenhuis
Alkmaar, Netherlands
3
St Antonius Ziekenhuis
Nieuwegein, Netherlands
4
CWZ
Nijmegen, Netherlands