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D4320C00015: A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer PatientsUnique Dataset IDProstat_AstraZe_2008_103
Clinical Trial Title
D4320C00015: A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients
Trial Summary and Conditions
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. Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
All data collected from conraol arm of study
Primary objectives The primary objectives of this study are: 1. To determine the effect of ZD4054 on overall survival (OS) compared to placebo, where overall survival is defined as time to death (from randomisation) from any cause 2. To assess the effect of ZD4054 on progression free survival (PFS) compared to placebo. PFS is defined as the time from randomisation until documentation of progressive metastatic disease, where progression is defined as any of: − One or more new bone lesions on bone scan (confirmed, if ??3 lesions, by CT, MRI or x-ray) − Development of malignant visceral disease on CT/MRI − Death in absence of progression. N.B. Any local recurrence of disease or loco-regional lymph node involvement is not classified as progression. Prostate cancer involving pelvic lymph nodes below the aortic bifurcation is classified as loco-regional disease. Any enlargement of distant lymph nodes above the aortic bifurcation to >2 cm by visual estimation is considered as progression. 2.2 Secondary objectives The secondary objectives of the study are: 1. To investigate the tolerability and safety profile of ZD4054 − Adverse events − Vital signs − Laboratory data − ECGs − Physical examination To investigate the effect of ZD4054 on time to prostate-specific antigen (PSA) progression compared to placebo, where time to PSA progression is defined as the time to the first PSA value ??50% from baseline seen in at least 2 consecutive PSA values 3. To assess the effects of ZD4054 on Health-related Quality of Life (HRQOL) compared to placebo 4. To investigate the effect of ZD4054 on time to symptomatic progression compared to placebo, defined as time to pain requiring opiate analgesia due to metastatic disease (where metastatic disease has been previously confirmed by bone scan or CT/MRI).
Primary Outcome Measures: ?Overall Survival 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 ] 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 Secondary Outcome Measures: ?Health Related Quality of Life [ Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks ] 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 ] Time to Symptomatic Progression [ Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks ]
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PROTOCOL: Zibotentan CSP D4320C00015 With Redactions_Redacted.pdf
CRF: aCRF D4320C00015.docx
DATA DICTIONARY: RDB Standards - D4320C00015 and D4320C00033.xlsx
DATA (COMPARATOR ARM): D4320C00015 De-Identified RDB Data.zip