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

Pilot study: Toxicity of oestradiol for adjuvant endocrine therapy in locally confined prostate cancer - OAT - Oestradiol adjuvant trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50312

Enrollment

200

Registered

2014-02-20

Start date

2014-09-08

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer prostate carcinoma

Interventions

During a run*in period of approximately 3 months subjects will self-administer four skin patches for transdermal application of oestradiol (100 *g per 24 h) per time, which will be changed twice wee

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 2.5 times normal). 14) Porfyria.

Design outcomes

Primary

Measure	Time frame
Incidence of cardiovascular events (number of cardiovascular events per 100 patient years).	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)