A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (ENTHUSE M0)

AstraZeneca

Status and phase: Terminated; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: ZD4054; Drug: Palcebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626548

D4320C00015

Details and patient eligibility

About

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.

Enrollment: 2,577 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,577 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Palcebo

ZD4054

Experimental group

Description:

ZD4054 (Zibotentan)

Treatment:

Drug: ZD4054