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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62522358 |
| Secondary identifying numbers | NTR577 |
- Submission date
- 08/03/2006
- Registration date
- 08/03/2006
- Last edited
- 11/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S.A. Lagerveld-Zaaijer
Scientific
Scientific
Academic medical Centre (AMC)
Department of Urology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5666030 |
|---|---|
| S.A.Zaaijer@amc.uva.nl |
Study information
| Study design | A single center open-label uncontrolled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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%. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | All patients will receive BAY 43-9006 400 mg twice a day (bid) for the period of 8 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sorafenib (BAY 43-9006) |
| Primary outcome measure | 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 measures | 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) |
| Overall study start date | 01/03/2006 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Urology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
