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22 May 2012
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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN62522358 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | NTR577 |
| Study hypothesis | 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%. |
| Lay summary | |
| Ethics approval | Received from local medical ethics committee |
| Study design | A single center open-label uncontrolled study |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Prostate cancer |
| Participants - inclusion criteria |
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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 01/03/2006 |
| Anticipated end date | 01/07/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 30 |
| Interventions | All patients will receive BAY 43-9006 400 mg twice a day (bid) for the period of 8 weeks. |
| Primary outcome measure(s) |
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 magnetic resonance imaging (MRI) 3. Micro vessel density (MVD) in biopsy and resected material |
| Secondary outcome measure(s) |
1. Toxicity by means of the remaining laboratory assessments
2. Number and severity of adverse events (AEs) 3. Number and severity of serious adverse events (SAEs) |
| Sources of funding | Academic Medical Centre (AMC) (Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr S.A. Lagerveld-Zaaijer |
| Address |
Academic medical Centre (AMC)
Department of Urology P.O. Box 22660 |
| City/town | Amsterdam |
| Zip/Postcode | 1100 DD |
| Country | Netherlands |
| Tel | +31 (0)20 5666030 |
| Fax | +31 (0)20 5669585 |
| S.A.Zaaijer@amc.uva.nl | |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Address |
Department of Urology
P.O. Box 22660 |
| City/town | Amsterdam |
| Zip/Postcode | 1100 DD |
| Country | Netherlands |
| Date applied | 08/03/2006 |
| Last edited | 11/08/2009 |
| Date ISRCTN assigned | 08/03/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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