All patients with histological proven prostate cancer who are eligible for laparoscopic radical prostatectomy will be asked to participate in the BAY 43-9006 study.
Conditions
Sponsors
Academic Medical Center, University of Amsterdam. Department of Urology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients > 18 years; 2. ECOG =1(2); 3. Biopsy proven prostate cancer; 4. Candidate for a radical prostatectomy and fit for surgery; 5. Clinical stage T1 – T2 Nx-0 Mx-0; 6. Adequate bone marrow function; 7. Adequate liver function; 8. Adequate renal function; 9. Adequate coagulation; 10. Men and partners must have adequate barrier birth control before and during and for 1 week after the trial; 11. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY43- 9006; 2. History of cardiac disease congestive heart failure, cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension; 3. History of chronic hepatits B or C and HIV infection; 4. Patients with seizure disorders (requiring medication); 5. Patients with evidence or history of bleeding diathesis; 6. Other investigational drug therapy within 30 days; 7.;Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study; 8. Unable to swallow oral medication; 9. Tumour/ disease specific criteria: chronic diarrhoea, bowel obstruction, degree of malnutrition, malabsorption; 10. Major surgery within 4 weeks before screening.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity by means of the remaining laboratory assessments; 2. Number and severity of AEs; 3. Number and severity of SAEs. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Response rate by means of PSA; 2. Quantitative changes in perfusion as measured by means of static and dynamic contrast enhanced ultrasound and static and dynamic contrast enhanced MRI; 3. Micro vessel density (MVD) in biopsy and resected material. | — |
Contacts
Public ContactS.A. Zaaijer
Academic medical Center (AMC) Department of Urology P.O. Box 22660
Outcome results
None listed