The purpose of this phase 3 study is to assess the safety and efficacy of enzalutamide (a newer antiandrogen agent) in patients with non metastatic prostate cancer.
The study will assess primarily, the time to delay metastatic disease. Secondary outcomes include assessment of improved overall survival, reduction in pain requirements, need for other treatments, PSA change and overall quality of life.
This is an international, multicentre trial and is currently recruiting patients through Tasman Oncology on the Gold Coast.
- Histologically or cytologically confirmed Prostate cancer
- Androgen deprivation therapy (LHRH agonist/antagonist or bilateral orchidectomy)
- Testosterone ≤ 50 ng/dL
- Progressive disease on androgen deprivation therapy
- PSA ≥ 2 µg/L
- PSA doubling time ≤ 10 months
- Asymptomatic prostate cancer with no evidence of metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy ≥ 12 months.
- Prior cytotoxic chemotherapy
- Use of other hormonal therapy or biologic therapy for prostate cancer or use of an investigational agent within 4 weeks of randomization
- History of another invasive cancer within 3 years of randomization
- History of seizure or any condition that may predispose to seizure
- Clinically significant cardiovascular disease
- Gastrointestinal disorder affecting absorption
- Major surgery within 4 weeks of randomization;
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
For more information, please talk with your treating urologist.