In this research project it is investigated if abdominal ultrasound measurement of prostate volume performed by the GP is equivalent to the prostate volume measured by the transrectal ultrasound (TRUS) performed by the urologist. Also the effect on…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the difference in prostate volume measured by the GP
(abdominal) and the urologist (TRUS), and the effect of this difference on the
risk of PCa calculated with the prostate risk calculator.
Secondary outcome
Measurement of compliance of the GP and urologist to the risk calculator
advice.
Background summary
Risk stratification helps to better identify those men at risk for (potentially
aggressive) PCa. The Erasmus MC has developed six risk calculators
(www.prostaatwijzer.nl) to calculate for example the risk of having PCa
detectable with prostate biopsy. Implementing the risk calculators in the daily
practice of general practitioners (GP*s) and urologists may prevent many
unnecessary prostate biopsies and overdiagnosis. Usually, most examinations of
the prostate are performed by an urologist in the hospital. Enabling the GP to
measure the prostate volume of a patient with an ultrasound himself,
facilitates the use of more advanced risk calculators in the primary health
care setting. Based on the results of PSA, digital rectal examination (DRE),
and prostate volume a risk can be calculated of finding (a potentially
aggressive) PCa at prostate biopsy. A strategy where the decision to biopsy is
dependent on this risk will reduce the amount of biopsies and the diagnosis of
low risk PCa. Currently prostate volume measurements (necessary for calculating
the risk) are only performed by the urologist. Volume measurement by the GP may
reduce referrals to the urologist.
Study objective
In this research project it is investigated if abdominal ultrasound measurement
of prostate volume performed by the GP is equivalent to the prostate volume
measured by the transrectal ultrasound (TRUS) performed by the urologist. Also
the effect on the risk calculated by the prostate risk calculators (nr. 3 and
nr. 4) will be investigated.
Study design
Prospective comparative clinical study, where the patient serves as its own
control.
Study burden and risks
In normal clinical practice each patient will visit his GP once and the
urologist once in case of an abnormal PSA. In between an extra visit to the GP
or a telephone consultation for PSA result is normal.
During this study patients will undergo an extra abdominal measurement of the
prostate volume at the GP. A total of 7 GP*s are included in this project but
only 3 will be able to perform the abdominal ultrasound measurements. Some of
the patients will have to make an extra visit to another GP for the prostate
volume measurement. All patients will have to visit the urologist no matter
what the results of the investigations at the GP are. Besides the extra visits,
the additional abdominal ultrasound does not pose any risk for the participant.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- men who have their PSA tested by the GP
- 50-70 years
- willing to have their prostate volume measured twice (the first time abdominally by a GP and the second time rectally by an urologist of the Prostaatcentrum zuidwest Nederland)
- signed informed consent
Exclusion criteria
- Prostate cancer in medical history
Design
Recruitment
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 |
|---|---|
| CCMO | NL47803.078.14 |