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

Phase 3TerminatedNCT00626548

AstraZeneca2,577 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

2,577

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (322)

Research Site

Tucson, Arizona, United States

Research Site

Greenbrae, California, United States

Research Site

Los Angeles, California, United States

Research Site

San Diego, California, United States

Research Site

San Francisco, California, United States

Research Site

Outcomes

Primary Outcomes

Overall Survival

Number of participants who have died at early analysis data cut off (DCO)

Time frame: From date of randomization until date of death, assessed up to 33 months

Progression Free Survival

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

Time frame: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks

Secondary Outcomes

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