Een onderzoek naar de veiligheid van het gebruik van oestradiol als hormoontherapie bij patiënten met lokaal gevorderde prostaatkanker die worden behandeld met uitwendige bestraling in combinatie met hormoontherapie
Recruiting
- Conditions
- ocally extended prostate cancer.
- Registration Number
- NL-OMON20250
- Lead Sponsor
- Erasmus MC, Dept. Urology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1) Men > 18 years.
2) Locally advanced prostate cancer.
Exclusion Criteria
1) Current endocrine treatment or previous therapy within 6 months (5-alpha reductase inhibitors are permitted).
2) Previous radiological confirmed deep venous thrombosis or pulmonary embolus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of cardiovascular events (number of cardiovascular events per 100 person years).
- Secondary Outcome Measures
Name Time Method 1) Compliance to the study intervention (measured by oestradiol serum levels at every visit).<br /><br>2) Incidence of endocrine related side effects.<br /> <br>3) Changes of metabolic serum parameters (liver function (SGOT, SGPT, bilirubin), endocrine (oestradiol, testosterone, PSA), lipid profile (HbA1c, cholesterol, HDL). <br /><br>4) Time to reach testosterone castration levels (during run-in period, T ¡Ü 1.7 nmol/L).<br /><br>5) Quality of Life (EORTC QC 30, PR25 potency, overall).