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Studying the influence of prednisone on docetaxel exposure.


- candidate number25253
- NTR NumberNTR6037
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-sep-2016
- Secondary IDsMEC 16-365 METC Erasmus MC
- Public TitleStudying the influence of prednisone on docetaxel exposure.
- Scientific TitleA pharmacokinetic study of docetaxel and prednisone in men with metastatic castration-resistant or hormone-sensitive orostate cancer.
- ACRONYMDoc-Pred
- hypothesisTo determine the influence of prednisone on docetaxel pharmacokinetics compared to docetaxel alone
- Healt Condition(s) or Problem(s) studiedProstate cancer
- Inclusion criteria1.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 criteria1. 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 Gilbertís 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate1-sep-2017
- Target number of participants18
- Interventionsdocetaxel vs docetaxel and prednisone
- Primary outcomeTo determine the influence of prednisone use on the pharmacokinetics (primary parameter AUC) of docetaxel, compared to docetaxel alone, in mCRPC and mHSPC patients.
- Secondary outcomeTo 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))
- TimepointsDuring cycle 3 and cycle 6 of docetaxel treatment
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Bodine Belderbos
- CONTACT for SCIENTIFIC QUERIES Bodine Belderbos
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD2-sep-2016 - 28-okt-2016


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