E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Men with prostate cancer where lifelong castration is indicated |
Mænd med prostatacancer, hvor livslang kastrationsbehandling er indiceret. |
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E.1.1.1 | Medical condition in easily understood language |
Men with prostate cancer where lifelong castration is indicated |
Mænd med prostatacancer, hvor livslang kastrationsbehandling er indiceret. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067329 |
E.1.2 | Term | Chemical male castration |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049629 |
E.1.2 | Term | Male operative castration |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052066 |
E.1.2 | Term | Metabolic syndrome |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Projektets formål er at undersøge om der er forskel på kirurgisk og medicinsk kastration, med en GnRH agonist, hos patienter med prostatacancer i forhold til:
- virkning på kropssammensætning
- glukose- og lipidmetabolismen
- knogletæthed
|
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Ikke relevant |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. diagnosed prostate cancer, where life long ADT is indicated.
2. Age 18 - 90 years
3. ECOG performance status 0-2 |
-Prostatakræftpatienter, hvor der er fundet indikation for livslang kastrationsbehandling.
-Alder 18 – 90 år
-ECOG performance status 0-2
|
|
E.4 | Principal 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 |
-Deltageren har tidligere fået medicinsk kastrationsbehandling i form af en GnRH agonist eller antagonist.
-Anti-androgen behandling inden påbegyndelse af kastrationsbehandlingen, antiflare behandling efter randomisering er dog undtaget.
-Blødersygdom eller anden tilstand der øger komplikationsriskion for operation uforholdsvis meget.
-Tidligere behandlet for knogleskørhed udover kalk og D-vitamin.
-Kendt diabetes og/eller HbA1C > 6,5.
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|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Change in fasting blodglucose
2. percent change in abdominal fat.
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-Ændring i faste blodsukker
-Den procentvise ændring i abdominal fedt
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|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. 12, 24 and 48 weeks.
2. 24 and 48 weeks |
1. 12, 24 og 48 uger
2. 24 og 48 uger. |
|
E.5.2 | 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) |
-Ændring i Bone Mineral Density (BMD)
-Ændring i knoglemarkører
-Ændring i Se-lipider
-Ændring i insulinfølsomhed målt ved OGGT med bestemmelse af Matsuda index.
-Ændring i inflammationsmarkører (CRP og Adiponectin)
-Ændring i NT-proBNP
-Ændring i BT og BMI
-Ændring i QoL målt ud fra evalueringsskemaerne EORTC QLQ-C30 og EORTC PR-25.
-Ændring i rejsningsfunktion ud fra Erection Hardness Score (EHS)
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|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 24 and 48 weeks.
2.-7.: 12, 24 and 48 weeks. |
1. 24 og 48 uger
2. - 7.: 12, 24 og 48 uger. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |