Surgical versus medical castration therapy: Are the effects on risk factors for cardiovascular disease and bone density different.

Conditions: Men with prostate cancer where lifelong castration is indicated
MedDRA version: 16.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 16.0Level: LLTClassification code 10067329Term: Chemical male castrationSystem Organ Class: 100000004865
MedDRA version: 16.0Level: LLTClassification code 10049629Term: Male operative castrationSystem Organ Class: 100000004865
MedDRA version: 16.0Level: PTClassification code 10052066Term: Metabolic syndromeSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2013-002553-29-DK

Lead Sponsor: Jens Sønksen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

1. diagnosed prostate cancer, where life long ADT is indicated.
2. Age 18 - 90 years
3. ECOG performance status 0-2
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

1. Previous androgen deprivation therapy.
2. Anti-androgen treatment befor start of ADT, antiflare treatment after randomisation is accepted.
3. Hemophelia or other condition that increases the risk of complications for orchiectomy unreasonably.
4. Prior treatment for osteoporosis.
5. Known diabetes and/or HbA1C > 6,5

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1. 12, 24 and 48 weeks.<br>2. 24 and 48 weeks;Main Objective: Is to investigate if the modality of Androgen deprivation therapy is of importance when looking at body composition, glucose- and lipid metabolism and bone density.;Secondary Objective: Not applicable;Primary end point(s): 1. Change in fasting blodglucose<br>2. percent change in abdominal fat.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. change in BMD<br>2. change in bonemarkers<br>3. change in se-lipids<br>4. change in insulin sensitivity<br>5. change in inflamation biomarkers<br>6. change in NT-proBNP<br>7. change in bloodpressure and BMI.<br>8. change in QoL inkl. EHS (erection hardness scale);Timepoint(s) of evaluation of this end point: 1. 24 and 48 weeks.<br>2.-7.: 12, 24 and 48 weeks.