Evaluation of Effects of Estetrol on Testosterone Suppression and Quality of Life in Prostate Cancer Patients Treated With an LHRH Agonist.

• Register: ClinicalTrials.gov
• Last refreshed on: 28 June 2021
• Main ID: NCT03361969
• Date of registration: 21/11/2017
• Prospective Registration: Yes
• Primary sponsor: Pantarhei Oncology B.V.
• Public title: Evaluation of Effects of Estetrol on Testosterone Suppression and Quality of Life in Prostate Cancer Patients Treated With an LHRH Agonist.
• Scientific title: 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.
• Date of first enrolment: April 16, 2018
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03361969
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Netherlands

Key inclusion & exclusion 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;

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Neoplasm

Intervention(s)

Drug: Estetrol

Drug: Placebo Oral Tablet

Primary Outcome(s)

Difference in mean daily hot flushes score between treatment groups [Time Frame: 168 days]

Difference in total testosterone levels between treatment groups [Time Frame: 168 days]

Difference in free testosterone levels between treatment groups [Time Frame: 168 days]

Secondary Outcome(s)

Questionnaire on Quality of Life [Time Frame: 168 days]

Change from baseline in endocrine parameters, adrenal androgen, dihydrotestosterone (DHT) and Sex Hormone Binding Globulin (SHBG) [Time Frame: 168 days]

Change from baseline in bone turnover markers [Time Frame: 168 days]

Change from baseline in lipids [Time Frame: 168 days]

Change from baseline in prostate-specific antigen (PSA) response [Time Frame: 168 days]

Secondary ID(s)

PR3109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors