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Completed

NCT Number: NCT03361969

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

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.

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Key information

Conditions

Prostatic Neoplasm Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hot Flashes Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Andros Men's Health Institutes, Arnhem, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Estetrol

Drug

estetrol formulated in tablets

Placebo oral tablet

Drug

placebo tablets

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Change from baseline in endocrine parameters, adrenal androgen, dihydrotestosterone (DHT) and Sex Hormone Binding Globulin (SHBG)

    Time frame: 168 days

    Effects on endocrine parameters (Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) and Estradiol (E2), adrenal androgens (Dehydroepiandrosterone sulfate (DHEAS)), dihydrotestosterone (DHT) and SHBG will be evaluated. Actual values at baseline and at the scheduled visits, as well as change from baseline values at the post-baseline visits will be described using summary statistics and graphs. Difference between the treatment groups will be evaluated.

  2. Change from baseline in prostate-specific antigen (PSA) response

    Time frame: 168 days

    Effects on PSA response will be evaluated. Actual values at baseline and at the scheduled visits, as well as change from baseline and percentage change from baseline values at the post-baseline visits will be described using summary statistics and graphs. Nadir and time to nadir will be described using summary statistics. Difference between the treatment groups will be evaluated.

  3. Questionnaire on Quality of Life

    Time frame: 168 days

    Effects on FACT-P questionnaire will be evaluated. FACT-P includes a 27-item "core" quality of life measure (FACT-G) grouped into 4 sub-scales: physical, social/family, emotional, and functional well-being. The prostate cancer-specific subscale contains an additional 12 items; 10 of which are prostate cancer specific physical problems. Items are rated on a 5-item Likert scale, from 0, "not at all", to 4, "very much". Total range of scores is from 0 - 156. Higher scores indicate higher degree of functioning and better quality of life.

    Total FACT-P scores, FACT-P general health subscale score (FACT-G) total score and all FACT-P subscale scores will be described at the scheduled visits using summary statistics and graphs. Differences between the treatment groups will be evaluated.

  4. Change from baseline in lipids

    Time frame: 168 days

    Effects on total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol and Low Density Lipoprotein (LDL) cholesterol will be evaluated. Actual values at baseline and at the schedule visits as well as change from baseline values at the post-baseline visits will be described using summary statistics and graphs. Differences between the treatment groups will be evaluated.

  5. Change from baseline in bone turnover markers

    Time frame: 168 days

    Effects on bone turnover markers osteocalcin and type I collagen telopeptide (CTX-1) will be evaluated. Actual values at baseline and at the schedule visits as well as change from baseline values at the post-baseline visits will be described using summary statistics and graphs. Differences between the treatment groups will be evaluated.

Sponsors and collaborators

Lead sponsor

Pantarhei Oncology B.V.

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2017
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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