Patients with metastatic hormone refractory prostate cancer
Conditions
Interventions
Product Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
Product Name: prednisolon
Pharmaceutical Form: Tablet
Sponsors
Finnish Uro-Oncological Group
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Proven adenocarcinoma of prostate Metastatic disease Hormone refractory prostate cancer PSA>10ug/l No previous cytostatic treatment except estramustine phosphate WHO PS18 years Normal laboratory values Hepatic/renal function: total bilirubin=6xUNL is OK. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Less than 4 weeks since surgery Prior radiotherapy>25% of bone marrow Less than 3 weeks since estramustine treatment stopped Prior therapy with radioisotopes Other malignant disease, except basalioma, within the past 5 years Serious liver disease Other serious illness or medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare time to treatment failure between two arms;Secondary Objective: Compare quality of life, response rate, safety and overall survival between two arms.;Primary end point(s): Time to treatment failure defined as 1) progression in PSA, 2) progression of evaluable or measurable disease, 3) unacceptable toxicity or 4) patients refusal to continue treatment. Quality of life using FACT-P questionnaire and a pain analysis using VAS. Response rate using RECIST criteria. Safety using CTCAE. Overall survival defined as the time between randomisation and death. | — |
Countries
Ireland, Sweden
Outcome results
None listed