Conditions: Prostate Cancer
Keywords: Hormone Resistant Prostate Cancer Endothelin A Receptor Antagonist Endothelin A Endothelin A antagonist
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2577
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Matching Placebo arm 2: ZD4054 (Zibotentan)

Interventions: intervention 1: ZD4054 intervention 2: Palcebo
Intervention descriptions: intervention 1: 10 mg once daily oral dose intervention 2: Matching Plcebo oral tablet once daily

Protocol document: