Men with prostate cancer where lifelong castration is indicated MedDRA version: 16.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: LLT Classification code 10067329 Term: Chemical male castration System Organ Class: 100000004865 MedDRA version: 16.0 Level: LLT Classification code 10049629 Term: Male operative castration System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Pamorelin
Pharmaceutical Form: Concentrate and solvent for solution for injection
Sponsors
Jens Sønksen
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. 12, 24 and 48 weeks. 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 2. percent change in abdominal fat. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. change in BMD 2. change in bonemarkers 3. change in se-lipids 4. change in insulin sensitivity 5. change in inflamation biomarkers 6. change in NT-proBNP 7. change in bloodpressure and BMI. 8. change in QoL inkl. EHS (erection hardness scale);Timepoint(s) of evaluation of this end point: 1. 24 and 48 weeks. 2.-7.: 12, 24 and 48 weeks. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Urology, Herlev Hospi
Department of Urology, Herlev Hospital
Outcome results
None listed