A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (ENTHUSE M0)
Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.
All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy.
Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients|
- Overall Survival [ Time Frame: From date of randomization until date of death, assessed up to 33 months ] [ Designated as safety issue: No ]Number of participants who have died at early analysis data cut off (DCO)
- Progression Free Survival [ Time Frame: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline
- Health Related Quality of Life [ Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
- Time to Prostate-specific Antigen (PSA) Progression [ Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
- Time to Symptomatic Progression [ Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||May 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Matching Plcebo oral tablet once daily
10 mg once daily oral dose
Other Name: Zibotentan
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626548
Show 330 Study Locations
|Principal Investigator:||Kurt Miller, Prof., M.D.||Charité Campus Benjamin Franklin|
|Principal Investigator:||Tia Higano, MD||University of Washington|