Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

Completed · Phase 4 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT01995513

Run by

Pfizer

People needed

509

Starts

2013-10-22

Expected to finish

2022-08-31

Last updated by the study team

2023-09-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• eResearch Technology — Philadelphia, Pennsylvania, United States
• Urology of Virginia, PLLC — Virginia Beach, Virginia, United States
• Border Medical Oncology Research Unit — Albury, New South Wales, Australia
• Ramsay Health Care Australia Pty Ltd — Albury, New South Wales, Australia
• Regional Imaging Border — Albury, New South Wales, Australia
• Terry White Chemist — Albury, New South Wales, Australia
• Concord Cancer Centre, Medical Oncology Department — Concord, New South Wales, Australia
• Concord Hospital Clinical Trials Pharmacy — Concord, New South Wales, Australia
• Epic Pharmacy Lismore — Lismore, New South Wales, Australia
• Macquarie University Hospital Pharmacy — North Ryde, New South Wales, Australia
• Macquarie University — North Ryde, New South Wales, Australia
• Epic Pharmacy Port Macquarie base hospital — Port Macquarie, New South Wales, Australia
• Port Macquarie Base Hospital,North Coast Cancer Institute — Port Macquarie, New South Wales, Australia
• North Shore Radiology and Nuclear Medicine — St Leonards, New South Wales, Australia
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Sydney Adventist Hospital — Sydney, New South Wales, Australia
• Northern NSW Local Health District — Tweed Heads, New South Wales, Australia
• Queensland Diagnostic Imaging — Tweed Heads, New South Wales, Australia
• Sydney Adventist Hospital — Wahroonga, New South Wales, Australia
• Regional Imaging — West Albury, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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