Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
With
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
PSA doubling time ≤ 9 months;
Screening PSA by the central laboratory ≥ 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer;
Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).
You may not be if
Prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization, or a single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before randomization is allowed.;
Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
Major surgery within 4 weeks before randomization;
Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
Known or suspected brain metastasis or active leptomeningeal disease;
History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence
Clareo Health | Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
