To investigate the difference between side and end-firing in transrectal prostate needle biopsies in terms of qualitative and quantitative prostate cancer detection.
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the prostate cancer detection rate
Secondary outcome
secondary endpoints are the number of cores invaded with prostate cancer,
nomogram for indolent cancer-score, Gleason score, complications and biopsy
length
Background summary
Research towards the efficacy of transrectal prostate biopsies has
predominantly focused on the amount of biopsy cores. However, variation in the
angle of entrance of the biopsy gun has been less studied. It is believed that
obtaining biopsy cores by end firing will improve the efficacy, because of an
improved sampling of the apical region.
Study objective
To investigate the difference between side and end-firing in transrectal
prostate needle biopsies in terms of qualitative and quantitative prostate
cancer detection.
Study design
all men with a prostate biopsy in a representative, Dutch, general hospital
with six participating urologists and two residents will be subjected to a
randomized controlled, single blind, single center, diagnostics trial. Men will
be randomized for a biopsy using an end-firing or a side-firing probe.
Intervention
A transrectal biopsy of the prostate with the use of an end-firing probe
versus the use of a side-firing probe.
Study burden and risks
there are no risks other than the risks for a prostate biopsy outside this
study.
Postbus 90157
4800 RL Breda
NL
Postbus 90157
4800 RL Breda
NL
Listed location countries
Age
Inclusion criteria
• All prostate biopsies
• PSA and DRE performed in advance of the biopsy
• Informed consent
Exclusion criteria
none
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00851292 |
| CCMO | NL28086.101.09 |