A pharmacokinetic study of Docetaxel and Prednisone in men with metastatic castration-resistant or hormone-sensitive prostate cancer.

A pharmacokinetic study of Docetaxel and Prednisone in men with metastatic castration-resistant or hormone-sensitive prostate cancer. - Doc-Pred

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42925

Enrollment

Registered

2016-08-10

Start date

2016-09-06

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

metastatic prostate cancer

Interventions

none

Docetaxel

mPCa

pharmacokinetics

Prednisone

Eligibility

Age

18 Years to 64 Years

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);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

Design outcomes

Primary

Measure	Time frame
To determine the influence of prednisone use on docetaxel pharmacokinetics compared to docetaxel alone in patients with metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC).	—

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))	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)