A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

• Status: Completed
• Trial end date: 2017-04-27
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Medivation, Inc.
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)

• Asymptomatic from prostate cancer

• Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening

• PSA ≥ 2 ng/mL at screening

Exclusion Criteria:

Has previously or is currently receiving:

• Hormonal therapy with intent to treat prostate cancer

• Systemic glucocorticoids

• Chemotherapy with the intent to treat prostate cancer

• Opiate analgesics for pain from prostate cancer

• Radiation therapy for treatment of the primary tumor or metastases

• Has history of known or suspected brain or skull metastases or leptomeningeal disease

• Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack

• Clinically significant cardiovascular disease