The purpose of this study is to evaluate the effect of E4 on the efficacy and health related quality of life of prostate cancer patients on LHRH agonist treatment.Primary objectives:• To assess the additional suppressive effects of E4 on total T and…
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The first primary outcome parameter in this study is to assess the effect of E4
on total testosterone and free testosterone levels.
The second primary parameter is to assess the effects of E4 on hot flushes.
Secondary outcome
Secondary outcome parameters are:
• To assess the effects of E4 on endocrine parameters, adrenal androgens, DHT
and SHBG;
• To assess the PSA response;
• To assess the effects of E4 on health related quality of life;
• To assess the effects of E4 on the lipid profile;
• To assess the effects of E4 on bone turnover;
• To assess the safety and tolerability of the E4 treatment.
Background summary
Estetrol (E4) is a potential new drug for the treatment of prostate cancer.
Study objective
The purpose of this study is to evaluate the effect of E4 on the efficacy and
health related quality of life of prostate cancer patients on LHRH agonist
treatment.
Primary objectives:
• To assess the additional suppressive effects of E4 on total T and free T in
patients with prostate cancer treated with an LHRH agonist;
• To assess the effects of E4 on hot flushes, one of the most bothersome side
effects of LHRH agonist treatment.
Secondary objectives:
• To assess the effects of E4 on endocrine parameters, adrenal androgens,
dihydrotestosterone (DHT) and sex hormone binding globulin (SHBG);
• To assess the PSA response;
• To assess the effects of E4 on health related quality of life;
• To assess the effects of E4 on the lipid profile;
• To assess the effects of E4 on bone turnover;
• To assess the safety and tolerability of the E4 treatment.
Study design
The current study is designed to evaluate the effect of E4 on the efficacy and
health related quality of life of prostate cancer patients on LHRH agonist
treatment.
Intervention
Patients with prostate cancer, qualifying for hormonal castration therapy with
an LHRH agonist will be assigned to one of two treatment groups, either the
active (Group 1) or the placebo group (Group 2). Patients will be receive
blinded study medication (oral administration) as follows:
Group 1: E4; provided as two E4 tablets per day
Group 2: Placebo; provided as two placebo tablets per day
Patients will be treated for 24 weeks with the study medication.
The study will start with a screening (visit 1). At the screening a physical
examination will take place, and vital signs (blood pressure, heart rate and
body weight) will be assessed. A blood sample will be taken for laboratory
tests.
At visit 2 patients will be randomised and will receive the study medication or
placebo. Patients are asked to take 2 tablets daily for 6 months.
At visit 2 to visit 9 a blood sample will be taken.
At visit 2 to visit 10 vital signs will be assessed.
At visit 6 and visit 9 patients are asked to fill in the FACT-P questionnaire
on their Quality of Life (including sex-related questions).
At visit 2, visit 4, visit 7, visit 9, and visit 10 patients are asked to fill
in a questionnaire on endocrine related symptoms (including sex-related
questions).
During the 6 month treatment period, patients are asked three times to keep a
diary for 1 week, to record hot flushes and their severity.
Study burden and risks
Small risks are related to blood sampling. Blood sampling can cause minor aches
and bruises at the puncture sites.
The risks of the study are small, patients will be monitored by the
investigators. The study medication has been given before to human (male)
subjects in clinical study PR3107. In this clinical study (PR3107 -
NL56592.056.16) side effects reported were headaches, nipple tenderness and
libido decrease, these are known side effects for estrogen therapy. Most side
effects were scored as being 'mild'.
We believe this research is justified because, based on earlier studies with
estetrol, it appears that estetrol minimally impacts the liver function. We
believe that combining LHRH analogues with estetrol further improves efficacy
of the LHRH treatment and simultaneously improves the quality of life of the
patients by reducing the hypo-estrogenic side effects associated with the LHRH
treatment in prostate cancer patients.
Boslaan 11
Zeist 3701 CH
NL
Boslaan 11
Zeist 3701 CH
NL
Listed location countries
Age
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 and 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 year.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-003708-34-NL |
| CCMO | NL63945.056.17 |