The proposed project aims at implementing the available scientific knowledge for recommending biopsies or active treatment, respectively, at the individual level in Dutch urological practice. To this end we have developed an internet based decision…
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are adherence, compliance and impact on the patient.
Secondary outcome
Alongside the implementation process, the data available on the number of
biopsies and referral to active surveillance before and after implementation of
the Prostaatwijzer ®, as well as costs, will be compared.
Background summary
The frequency of opportunistic screening for prostate cancer by the use of the
PSA test among men older than 50 years in The Netherlands is estimated to range
between 20 and 40% (www.cbs.nl). Current screening practice leads to many
prostate biopsies, and many of the prostate cancers found are in fact indolent,
i.e., not representing any threat to the patients* health. In the ERSPC
screening study the frequency of indolent cancers is in the range of at least
50%. The current scientific state of the art allows for basing the decision to
take a prostate biopsy or not on individualized risk estimation, so that
biopsies are only taken in patients who are at a relevant risk of having
prostate cancer and the total
biopsy rate is reduced. Similarly, the decision for active treatment or active
surveillance can be based on individualized estimation of the risk of an
indolent prostate cancer.
Study objective
The proposed project aims at implementing the available scientific knowledge
for recommending biopsies or active treatment, respectively, at the individual
level in Dutch urological practice. To this end we have developed an internet
based decision tool (risk calculator), De Prostaatwijzer ®, which allows to
estimate individualized risks.
Study design
The implementation of the Prostaatwijzer® will be prospectively evaluated. For
this at least 600 men in 5 regional medical
centres will be included. Specifically, two decision levels will be addressed:
the chance of finding prostate cancer if a man undergoes a prostate biopsy and,
in case prostate cancer is found, an advice to undergo active surveillance
within a protocol if the chance of indolent prostate cancer is high.
Study burden and risks
There are no risks associated with participation in the trial. The extra burden
for participants as compared to standard tests consists of filling out a
questionnaire twice. This will cost the patient approximately 15 minutes per
questionnaire.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
* Men between 55 and 75 years old
* Confronted with the option of undergoing a diagnostic prostate biopsy or wanting to be screened for prostate cancer
* Signed informed consent
Exclusion criteria
History of prostate cancer
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 | NL23318.078.08 |