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A Randomized Study of Enzalutamide in Patients with Localized Prostate Cancer Undergoing Active Surveillance (ENACT)

Eligibility: Prostate cancer patients undergoing active surveillance who have biopsy confirmed adenocarcinoma and no previous radiotherapy, surgery, chemotherapy or hormonal therapy to treat prostate cancer.

This study is a clinical trial to compare the efficacy, safety and extension of time to prostate cancer progression between patients with prostate cancer treated with enzalutamide versus patients undergoing active surveillance. Enzalutamide is an anti-androgen drug that is approved for use in men with castrate-resistant prostate cancer (CRPC), but is not yet approved in men with low-risk or intermediate-risk prostate cancer.  Patients are eligible if they have clinically localized, histologically proven prostate cancer that is categorized as low risk or intermediate risk and who have elected active surveillance.  Patients must have been diagnosed within 6 months with a biopsy. 

As part of this clinical trial, subjects will be randomized to receive treatment with enzalutamide (160 mg per day), administered as four 40 mg capsules once daily, or to active surveillance during the one year study treatment period.  Following the one year treatment period, patients will be followed for one additional year without any treatment.  Patients will follow up with the study doctor every 3 months for these 2 years.  During the study period, the patient’s disease will be monitored using PSA tests, digital rectal examinations, and hormonal blood tests, including testosterone, DHT, dihydroepiandrosterone, androstenedione and estradiol. Patients will also complete quality of life, sexual function, anxiety, and lifestyle questionnaires. All patients will have a prostate biopsy at 12 months and 24 months.

The potential side effects of treatment with enzalutamide are: fatigue, loss of strength, headache, anxiety, hot flashes, high blood pressure, difficulty remembering, difficulty thinking clearly, reduced concentration, broken bones, low white blood cell counts, hallucination, dry skin, itching, restless leg syndrome, enlarged male breasts, vertigo (sensation of loss of balance), nosebleeds and/or rash.  There is a rare potential side effect of seizures which occurred in less than 1% of patients taking enzalutamide.

For more information, please contact our research coordinator at 516-535-4184 or urologyresearch@nyuwinthrop.org

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