Prostate Cancer Clinical Trial
— BIOPRESOfficial title:
The BIOPRES Trial; Transrectal BIOpsies of the PRostate: End Versus Side-firing
The purpose of this study is to study the difference in prostate cancer between two prostate biopsy techniques, namely end-firing and side-firing. These differ in the angle at which the prostate is biopsied.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - PSA and DRE performed in advance of the biopsy - Informed consent - Number of biopsy cores according to the volume dependent biopsy protocol (8 cores in prostates with a volume less than 40 mL., 10 in 40-60 mL. and 12 in >60 mL.) Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Netherlands | Amphia hospital | Breda | Noord-Brabant |
Lead Sponsor | Collaborator |
---|---|
Amphia Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The presence of prostate cancer in the tissue obtained by prostate needle biopsy | This outcome parameter will be available 5 days after the biopsy has been done. E.g. there will be virtually no 'follow-up' period. | No | |
Secondary | Number of cores invaded with prostate cancer | All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks. | No | |
Secondary | Gleason score | All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks. | No | |
Secondary | Complications | All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks. | No | |
Secondary | Biopsy length | All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks. | No | |
Secondary | Nomogram score for indolent prostate cancer | All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks. | No |
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