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

Astellas

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Enzalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01302041

2010-021287-16 (EudraCT Number)

9785-CL-0321

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

67 participants in 1 patient group

Enzalutamide

Experimental group

Description:

Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.

Treatment:

Drug: Enzalutamide