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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN62522358 |
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Date of registration:
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08/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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Date of first enrolment:
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01/03/2006 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN62522358 |
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Study type:
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Interventional |
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Study design:
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A single center open-label uncontrolled study (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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S.A.
Lagerveld-Zaaijer |
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Address:
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Academic medical Centre (AMC)
Department of Urology
P.O. Box 22660
1100 DD
Amsterdam
Netherlands |
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Telephone:
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+31 (0)20 5666030 |
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Email:
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S.A.Zaaijer@amc.uva.nl |
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Affiliation:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate cancer
Cancer
Malignant neoplasm of prostate
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Intervention(s)
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All patients will receive BAY 43-9006 400 mg twice a day (bid) for the period of 8 weeks.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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)
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Source(s) of Monetary Support
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Academic Medical Centre (AMC) (Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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