Condition category
Cancer
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
11/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S.A. Lagerveld-Zaaijer

ORCID ID

Contact details

Academic medical Centre (AMC)
Department of Urology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR577

Study information

Scientific title

Acronym

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%.

Ethics approval

Received from local medical ethics committee

Study design

A single center open-label uncontrolled study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Sorafenib (BAY 43-9006)

Primary outcome measures

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 trial start date

01/03/2006

Overall trial end date

01/07/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

30

Participant 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

Recruitment start date

01/03/2006

Recruitment end date

01/07/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Urology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes