A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer

Phase 3

Terminated

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Patients who answer TRUE to the following criteria may be eligible to participate in this study.

Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
Currently receiving treatment with surgical or medical castration

Exclusion Criteria

Patients who answer TRUE to the following may NOT be eligible to participate in this study.

Currently using opiate based pain killers for cancer related pain
Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
Suffering from heart failure or had a myocardial infarction within last 6 months
A history of epilepsy or seizures

Arm && Interventions

Group	Intervention	Description
Placebo	Palcebo	Matching Placebo
ZD4054	ZD4054	ZD4054 (Zibotentan)

Primary Outcome Measures

Name	Time	Method
Overall Survival	From date of randomization until date of death, assessed up to 33 months	Number of participants who have died at early analysis data cut off (DCO)
Progression Free Survival	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

Name	Time	Method
Health Related Quality of Life	Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Time to Prostate-specific Antigen (PSA) Progression	Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Time to Symptomatic Progression	Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks

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