A phase III trial comparing docetaxel every third week to biweekly docetaxel monotherapy in metastatic hormone refractory prostate cancer patients. - PROSTY
- Conditions
- Patients with metastatic hormone refractory prostate cancer
- Registration Number
- EUCTR2004-004295-37-SE
- Lead Sponsor
- Finnish Uro-Oncological Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 360
Proven adenocarcinoma of prostate
Metastatic disease
Hormone refractory prostate cancer
PSA>10ug/l
No previous cytostatic treatment except estramustine phosphate
WHO PS<= 2
Age>18 years
Normal laboratory values
Hepatic/renal function: total bilirubin<= 1xUNL, ALAT and ASAT <= 2.5xUNL, Alk phos<=6xUNL, creatinine<=1.5xUNL. If extensive bone disease, Alk phos >=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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method