No registrations found.
ID
Source
Brief title
Health condition
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.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
1. Toxicity by means of the remaining laboratory assessments;
2. Number and severity of AEs;
3. Number and severity of SAEs.
Background summary
BAY 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.
Study objective
In 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%.
Intervention
All patients will receive BAY 43-9006 400 mg bid for the period of 8 weeks.
P.O. Box 22660
S.A. Zaaijer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
P.O. Box 22660
S.A. Zaaijer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL533 |
| NTR-old | NTR577 |
| Other | : N/A |
| ISRCTN | ISRCTN62522358 |