Studying the influence of prednisone on docetaxel exposure.

A pharmacokinetic study of docetaxel and prednisone in men with metastatic castration-resistant or hormone-sensitive orostate cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22101

Enrollment

Registered

2016-09-02

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with metastatic castration-resistant and hormone-sensitive prostate cancer

Interventions

docetaxel vs docetaxel and prednisone

Eligibility

Inclusion criteria

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

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 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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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))	—

Contacts

Public ContactBodine Belderbos

's Gravendijkwal 230

b.belderbos@erasmusmc.nl06-41647236

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)