Studienregister

Studienregister der Deutschen Gesellschaft für Urologie e.V.

AP 52/08 - Enthuse M0

PrüfplancodeISRCTNEudraCTClinicaltrials.govDRKS
Enthuse M0.NCT00626548

A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD 4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients

Status: Aktiv (Rekrutierung geschlossen)

Studienziel / Fragestellung

Primäres Prüfziel

  • Progression-free survival and Overall survival [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]

Sekundäre Prüfziele

  • Tolerability and safety profile of ZD4054 (Zibotentan) [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
  • Health Related Quality of Life [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
  • Time to prostate-specific antigen (PSA) progression [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
  • Time to symptomatic progression [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]

Diagnose

Patientenmerkmale

Stadium

Nicht metastasiert, hormonresistent

Alter

18-100

Einschlusskriterien

- Age 18 or older, male
- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases)
- Increasing Prostate Specific Antigen (PSA) over a one month period
- Currently receiving treatment with surgical or medical castration

Ausschlusskriterien

- Currently using opiates based pain killers) for cancer related pain
- Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
- Suffering from heart failure or had a myocardial infarction within last 6 months
-  A history of epilepsy or seizures

Studiendesign

  • Phase III
  • Multizentrisch
  • Prospektiv
  • Randomisiert
  • Zweiarmig
  • Doppelblind
  • Placebo-kontrolliert

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

AstraZeneca GmbH

    Leiter der klinischen Prüfung

    Prof. Dr. med. Jürgen Gschwend

    nach oben