No registrations found.
ID
Source
Brief title
Health condition
patients with metastatic castration-resistant and hormone-sensitive prostate cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the influence of prednisone use on the pharmacokinetics (primary parameter AUC) of docetaxel, compared to docetaxel alone, in mCRPC and mHSPC patients.
Secondary outcome
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))
Background summary
In this study we try to determine the influence of prednisone on the exposure of docetaxel vs docetaxel alone in men with metastatic castration-resistant or hormone-sensitive prostate cancer.
Study objective
To determine the influence of prednisone on docetaxel pharmacokinetics compared to docetaxel alone
Study design
During cycle 3 and cycle 6 of docetaxel treatment
Intervention
docetaxel vs docetaxel and prednisone
Bodine Belderbos
Rotterdam 3015CE
The Netherlands
06-41647236
b.belderbos@erasmusmc.nl
Bodine Belderbos
Rotterdam 3015CE
The Netherlands
06-41647236
b.belderbos@erasmusmc.nl
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
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): Serum creatinin > 1.5 x upper limit of normal (ULN). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min will be excluded.
8. Abnormal liver functions consisting of any of the following (within 21 days before randomization):
o Total bilirubin ≥ 1 x ULN (except for patients with documented Gilbert’s disease)
o alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) ≥ 2.5 x ULN. (in case of liver metastases >5 x ULN)
o Alkaline phosphatase (AF) > 5 x ULN (in case of bone metastases > 10 x ULN)
9. Abnormal hematological blood counts consisting of any of the following (within 21 days before randomization):
o Absolute neutrophil count ≤ 1.5 x 109/L
o Platelets ≤ 100 x 109/L
10. Geographical, psychological or other non-medical conditions interfering with follow-up
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5857 |
| NTR-old | NTR6037 |
| Other | METC Erasmus MC : MEC 16-365 |