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van CCT (UK)


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van CCT (UK)


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.


- candidate number1926
- NTR NumberNTR577
- ISRCTNISRCTN62522358
- Date ISRCTN created8-mrt-2006
- date ISRCTN requested7-mrt-2006
- Date Registered NTR11-jan-2006
- Secondary IDsN/A 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMBAY 43-9006 before radical prostatectomy
- hypothesisIn view of good pre-clinical and clinical results, it is thought that patients with prostate cancer will benefit from BAY 43-9006 in a neoadjuvant setting. We anticipate a benefit with the treatment of BAY 43-9006 when there is a PSA decline of more than 25%.
- Healt Condition(s) or Problem(s) studiedProstate cancer
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type-
- Studytypeintervention
- planned startdate 1-mrt-2006
- planned closingdate1-jul-2008
- Target number of participants30
- InterventionsAll patients will receive BAY 43-9006 400 mg bid for the period of 8 weeks.
- Primary outcome1. 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.
- Secondary outcome1. Toxicity by means of the remaining laboratory assessments; 2. Number and severity of AEs; 3. Number and severity of SAEs.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.A. Zaaijer
- CONTACT for SCIENTIFIC QUERIES M.H. Wink
- Sponsor/Initiator Academic Medical Center (AMC), Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Urology
- PublicationsN/A
- Brief summaryBAY 43-9006 or Sorafenib (family of the RAF kinase inhibitors) is an orally bio available anti-angiogenic drug with anti-proliferative and anti-angiogenic properties which targets the tumour and neo-vasculature. In view of good pre-clinical and clinical results, it was decided to investigate BAY 43-9006 in a translational study to monitor the effects of BAY 43-9006 in a neo-adjuvant setting and to evaluate the benefit in patients with prostate cancer in the future.
- Main changes (audit trail)
- RECORD11-jan-2006 - 10-mrt-2006


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