Pilot study: Toxicity of oestradiol for adjuvant endocrine therapy in locally confined prostate cancer

Completed

Conditions: Prostate cancer
prostate carcinoma
10038597
10036958

Registration Number: NL-OMON50312

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

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.

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.
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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of cardiovascular events (number of cardiovascular events per 100<br /><br>patient years).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Compliance to the study intervention (measured by oestradiol serum levels at<br /><br>every visit).<br /><br>- Incidence of endocrine related side effects.<br /><br>- Changes of metabolic serum parameters (liver function (SGOT, SGPT,<br /><br>bilirubin), endocrine (oestradiol, testosterone, PSA), lipid profile (HbA1c,<br /><br>cholesterol, HDL).<br /><br>- Time to reach testosterone castration levels (during run-in period, T * 1.7<br /><br>nmol/L).<br /><br>- Quality of Life (EORTC QC 30, PR25 potency, overall).</p><br>