Castration-resistant prostate cancer
Conditions
Interventions
Enzalutamide
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: Main inclusion criteria: 1. Age 50 or older. 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. 3. Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone analogue or bilateral orchidectomy. 4. Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bone disease. 5. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT 6. No prior cytotoxic chemotherapy for prostate cancer. 7. Asymptomatic or mildly symptomatic from prostate cancer. 8. Written informed consent.
Exclusion criteria
Exclusion criteria: Main exclusion criteria: 1. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment. 2. Known or suspected brain metastasis or active leptomeningeal disease. 3. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of 18F-FDHT PET/CT as a predictor of treatment response | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of 'treatment response and clinical survival endpoints' versus 'no treatment response and clinical survival endpoints' | — |
Contacts
Public ContactI.J. Jong, de
University Medical Center Groningen Hanzeplein 1
Outcome results
None listed