Studienregister

Studienregister der Deutschen Gesellschaft für Urologie e.V.

AP 52/08 - Enthuse M0

AcronymISRCTNEudraCTClinicaltrials.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: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

  • 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 ]

Secondary Outcomes

  • 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 ]

Diagnosis

Patient attributes

Stage

Non-metastatic, hormone-resistant

Age

18-100

Inclusion criteria

- 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

Exclusion criteria

- 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

Trial design

  • Phase III
  • Multicenter
  • Prospective
  • Randomized
  • Two-arm
  • Double-blind
  • Placebo-controlled

Documents (password protected)

Responsibilities in overall trial

AstraZeneca GmbH

    National Coordinating Investigator

    Prof. Dr. med. Jürgen Gschwend

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