Castration-resistant prostate cancer
Conditions
Interventions
Product Name: enzalutamide
Product Code: MDV3100
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ENZALUTAMIDE
CAS Number: 915087-33-1
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
Male
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 |
|---|---|
| Main Objective: Primary objective is to evaluate 18F-FDHTPET/CT as an early treatment response marker in patients with metastasized CRPC to be treated with enzalutamide. ;Secondary Objective: Secondary objective is to collect biopsies of prostate cancer bone and/or lymph node metastases, blood and urine specimens for future research. ;Primary end point(s): Association of 18F-FDHT PET/CT prior to start of enzalutamide (study week 1) with treatment response. Association of delta (study week 1 and 5) 18F-FDHT PET/CT with treatment response. ;Timepoint(s) of evaluation of this end point: See above E.5.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Collection and storage of biomaterial for future research.;Timepoint(s) of evaluation of this end point: Prior to start of enzalutamide (study week 1) and after 12 weeks of treatment (study week 13) | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Urology
University Medical Center Groningen
Outcome results
None listed