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

NCT03361969 | Completed Phase 2

• 1 other identifier: PR3109
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

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.

Conditions

Prostatic Neoplasm

Keywords

quality of life; hot flushes; prostate cancer; testosterone

Outcome Measures

Primary Outcomes (3)

• Difference in total testosterone levels between treatment groups

  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.

  168 days

• Difference in free testosterone levels between treatment groups

  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.

  168 days

• Difference in mean daily hot flushes score between treatment groups

  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.

  168 days

Secondary Outcomes (5)

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

  168 days

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

  168 days

• Questionnaire on Quality of Life

  168 days

• Change from baseline in lipids

  168 days

• Change from baseline in bone turnover markers

  168 days

Study Arms (2)

estetrol

ACTIVE COMPARATOR

Drug: Estetrol

placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

Estetrol DRUG

estetrol formulated in tablets

estetrol

Placebo Oral Tablet DRUG

placebo tablets

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pantarhei Oncology B.V.: lead

Study Sites (6)

Andros Men's Health Institutes

Arnhem, Gelderland, 6803 AA, Netherlands

Location

Noord West Ziekenhuis

Alkmaar, Netherlands

Location

St Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

CWZ

Nijmegen, Netherlands

Location

Antonius Ziekenhuis

Sneek, Netherlands

Location

Isala Zwolle

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Hot Flashes

Interventions

Estetrol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estriol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 5, 2017
• Study Start: April 16, 2018
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

NL (6)