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Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

NCT01995513

CompletedPhase 4

Sponsor: Pfizer

Conditions: Prostate Cancer

Interventions: Enzalutamide, Abiraterone, Placebo for Enzalutamide, Prednisone

Countries: United States, Australia, Belgium, Denmark, Finland, France, Italy, Slovakia

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Men with metastatic castration-resistant prostate cancer
* Progressive disease on androgen deprivation therapy
* Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
* ECOG performance score ≤ 1
* Estimated life expectancy of ≥ 12 months

Exclusion Criteria:

* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer
* Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
* History of brain metastasis, active leptomeningeal disease or seizure
* Severe cardiovascular or hepatic disease
* Pituitary or adrenal dysfunction

Locations (95)

Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Virginia Beach, Virginia, United States
Albury, New South Wales, Australia
Albury, New South Wales, Australia
Albury, New South Wales, Australia
Albury, New South Wales, Australia
Concord, New South Wales, Australia
Concord, New South Wales, Australia
Lismore, New South Wales, Australia
North Ryde, New South Wales, Australia
North Ryde, New South Wales, Australia
Port Macquarie, New South Wales, Australia
Port Macquarie, New South Wales, Australia
St Leonards, New South Wales, Australia
St Leonards, New South Wales, Australia
Sydney, New South Wales, Australia
Tweed Heads, New South Wales, Australia
Tweed Heads, New South Wales, Australia
Wahroonga, New South Wales, Australia
West Albury, New South Wales, Australia
Westmead, New South Wales, Australia
Auchenflower, Queensland, Australia
Auchenflower, Queensland, Australia
Chermside, Queensland, Australia
Hope Island, Queensland, Australia
South Brisbane, Queensland, Australia
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