A single center open-label uncontrolled study to investigate the PSA and tumor vascularization response rate of neoadjuvant therapy with BAY 43-9006 single agent therapy in patients with operable prostate cancer.

• Conditions: 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.

• Registration Number: NL-OMON28891
• Lead Sponsor: Academic Medical Center, University of Amsterdam. Department of Urology

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Response rate by means of PSA;<br>2. Quantitative changes in perfusion as measured by means of static and dynamic contrast enhanced ultrasound and static and dynamic contrast enhanced MRI; <br>3. Micro vessel density (MVD) in biopsy and resected material.

Secondary Outcome Measures

Name	Time	Method
1. Toxicity by means of the remaining laboratory assessments;<br>2. Number and severity of AEs;<br>3. Number and severity of SAEs.