Men with castration resistant prostate cancer MedDRA version: 14.0 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ketoconazole
Pharmaceutical Form: Tablet
CAS Number: 65277-42-1
Other descriptive name: KETOCONAZOLE
Product Name: Estramustine
Pharmaceutical Form: Tablet
CAS Number: 4891-15-0
Other d
Sponsors
Bo Lennernäs
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients with histological evidence of prostate cancer with verified progressive CRPC. Patients should have received prior castration hormonal therapy (ablatio, or GnRH agonists) in any form with the addition of antiandrogens and also tried excluding the antiandrogen (antiandrogen withdrawal effect). Ongoing GnRH therapy should continue. Testosterone should be within castration level. PSA > 10 ng/ml, and disease progression reflected by PSA increase, with the latest value within 1 month. WHO performance 0-2. Life expectancy > 3 months. Laboratory requirements: (a) Haematology: - Neutrophils > 1.5 x 109/L - Haemoglobin > 10 g/dl. - Platelets > 100 x 109/L (b) Hepatic function: -Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior chemotherapy for CRPC within ???? months Treatment with steroids within the last ????? months. Prior study drug (non chemotherapy) within 4 weeks prior to inclusion Other active malignant disease (except basalioma) within the past 5 years. Other serious illness or medical condition: (a) Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry; (b) Uncontrolled infection (c) Peptic ulcer on medication, insulin-requiring diabetes mellitus or other contraindications for the use of corticosteroids. (d) History of thromboembolic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of KEES on PSA response, ie the proportion of patients with a PSa decline by > 50 % compared to baseline value within 12 weeks of 1st day of chemotherapy.;Secondary Objective: To evaluate toxicity and safety of KEES treatment (CTCAE v3.0 toxicity, nature, incidens and severity of adverse events). To evaluate quality of life measured with FACT-P.;Primary end point(s): PSA response The proportion of patients with a PSA decline by > 50%, compared to baseline value, within 12 weeks after 1st day of chemotherapy. | — |
Countries
Sweden
Outcome results
None listed