E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic prostate cancer |
Gemetastaseerd prostaatkanker |
|
E.1.1.1 | Medical condition in easily understood language |
Metastatic prostate cancer |
Uitgezaaid prostaatkanker |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
To determine the influence of prednisone use on the pharmacokinetics (primary parameter AUC) of docetaxel, compared to docetaxel alone, in mCRPC and mHSPC patients. |
De invloed van prednisone op de farmacokintiek van docetaxel bepalen en deze vergelijken met de farmacokinetiek van docetaxel zonder prednison, bij patienten met gemetastaseerd prostaatkanker, in castratie-resistente en hormoon-sensitieve setting. |
|
E.2.2 | Secondary objectives of the trial |
• To evaluate the incidence and severity of side-effects of treatment with docetaxel in absence and presence of prednisone.
• Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax)) |
- Evalueren van de incidentie en Ernst van bijwerkingen van de behandeling met docetaxel in aan-/afwezigheid van prednison
- Andere farmacokinetische uitkomsten (klaring, maximum concentratie Cmax) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologicallly or cytologically confirmed adenocarcinoma of the prostate without neuro-endocrine differentitation or small cell features.
2. Continued androgen deprivation therapy either by gonadotropin releasing hormone (GnRH) analogues or orchiedectomy
3. Age ≥18 years
4. Metastatic disease progression
5. ECOG performance status 0-1
6. Written informed consent according to ICH-GCP
|
1. histologisch en cytologisch bevestigd adenocarcinoom van prostaat zonder neuro-endocriene differentiatie
2. gecontinueerde androgeen deprivatie therapie, ofwel via GnRH analogen ofwel via orchidectomy
3. Leeftijd >18 jaar
4. Gemetastaseerde ziekte
5. ECOG 0-1
6. Informed consent getekend |
|
E.4 | Principal exclusion criteria |
1. Impossibility or unwillingness to take oral drugs
2. Serious concurrent illness or medical unstable condition requiring treatment
3. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent
4. Known hypersensitivity to studiemedication
5. Use of medication or dietary supplements known to induce CYP3A
6. Any active systemic or local bacterial, viral, fungal - or yeast infection.
7. Abnormal renal function defined as (within 21 days before randomization)
8. Abnormal liver functions consisting of any of the following (within 21 days before randomization):
9. Abnormal hematological blood counts consisting of any of the following (within 21 days before randomization):
10. Geographical, psychological or other non-medical conditions interfering with follow-up
|
1. onvermogen tot het slikken van orale medicatie
2. Huidige ziekte of medische onstabiele conditie die behandeling vereist
3. Symptomatische CNS metastasen of voorgeschiedenis van psychiatrische stoornis die goede informed consent procedure verhindert.
4. Bekende overgevoeligheid voor studiemedicatie
5. Medicatie of voedingssupplementen waarvan we weten dat we CYP3A induceren
6. Een actieve systemische of locale infectie
7. Abnormale nierfunctie
8. Abnormale leverfunctie
9. Abnormale beenmergfunctie
10. Geografische of psychologische conditie die follow-up verhindert |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To determine the influence of prednisone use on the pharmacokinetics (primary parameter AUC) of docetaxel, compared to docetaxel alone, in mCRPC and mHSPC patients. |
De invloed van prednisone op de farmacokintiek van docetaxel bepalen en deze vergelijken met de farmacokinetiek van docetaxel zonder prednison, bij patienten met gemetastaseerd prostaatkanker, in castratie-resistente en hormoon-sensitieve setting. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of study |
Einde van de studie |
|
E.5.2 | Secondary end point(s) |
• To evaluate the incidence and severity of side-effects of treatment with docetaxel in absence and presence of prednisone.
• Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax)) |
- Evalueren van de incidentie en Ernst van bijwerkingen van de behandeling met docetaxel in aan-/afwezigheid van prednison
- Andere farmacokinetische uitkomsten (klaring, maximum concentratie Cmax) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of Study |
Einde van de studie |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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 | No |
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 | Yes |
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 |
Cross-over design, elke patient is zijn eigen controle |
Cross-over design, Each patient is his own control |
|
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 | No |
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
|
LVLS |
Laatste bezoek van laatste studiepatient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |