A single center open-label uncontrolled study to investigate the prostate specific antigen (PSA) and tumor vascularization response rate of neoadjuvant therapy with BAY 43-9006 single agent therapy in patients with operable prostate cancer
- Conditions
- Prostate cancerMalignant neoplasm of prostateCancer
- Registration Number
- ISRCTN62522358
- Lead Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 30
1. Patients >18 years
2. Eastern Cooperative Oncology Group (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
1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006
2. History of cardiac disease congestive heart failure, cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension
3. History of chronic hepatitis B or C and human immunodeficiency virus (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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method