Pilot study: Toxicity of oestradiol for adjuvant endocrine therapy in locally confined prostate cancer
- Conditions
- Prostate cancerMedDRA version: 17.1Level: PTClassification code 10071119Term: Hormone-dependent prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005479-42-NL
- Lead Sponsor
- Erasmus MC, Dept. Urology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
1) Men = 18 years.
2) Locally advanced prostate cancer.
3) Selected for at least two years of adjuvant endocrine therapy and EBRT.
4) Signed informed consent.
5) Testosterone serum level > 6 nmol/l.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
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.
3) Cerebrovascular event (TIA or CVA) within 6 months.
4) Coronary heart disease within 6 months.
5) Instable angina pectoris within 6 months.
6) Congenital thrombofilic diseases.
7) Thrombolic disease within 6 months.
8) Heart failure as defined by NYHA class >2.
9) Hypertension (not corrected by medication) >160/100 mmHg. If either systolic or diastolic value is higher than these values the patient is not eligible.
10) Suboptimal regulated diabetes mellitus or de novo diabetes mellitus as defined by HbA1c of over 6,5% (48 mmol/mol).
11) Rheumatoid arthritis.
12) Impaired renal function as defined by a GFR < 30 ml/ min/1,73 m2
13) Acute liver failure or reduced liver function showing as increased serum parameters (SGOT, SGPT, bilirubine > 2.5 times normal).
14) Porfyria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To analyse the safety of oestradiol in the setting of endocrine treatment for locally extended prostate cancer adjuvant to radiotherapy.;Secondary Objective: 1) Analyse compliance to the study intervention (measured by oestradiol serum levels)<br>2) Analyse the incidence of endocrine therapy related side effects<br>3) Analyse changes of metabolic serum parameters<br>4) Analyse time to reach testosterone castration levels<br>5) Analyse quality of Life (EORTC QC 30, PR25 potency, overall);Primary end point(s): Incidence of cardiovascular events (number of cardiovascular events per 100 person years).;Timepoint(s) of evaluation of this end point: Continuous
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Compliance to the study intervention (measured by oestradiol serum levels at every visit).<br>2) Incidence of endocrine related side effects.<br>3) Changes of metabolic serum parameters (liver function (SGOT, SGPT, bilirubin), endocrine (oestradiol, testosterone, PSA), lipid profile (HbA1c, cholesterol, HDL).<br>4) Time to reach testosterone castration levels (during run-in period, T = 1.7 nmol/L).<br>5) Quality of Life (EORTC QC 30, PR25 potency, overall).;Timepoint(s) of evaluation of this end point: Continuous.