The following objectives have been defined for PROCABIO:1. Integration of biomarkers in an updated and improved model for the prediction of indolent prostate cancer.2. Integration of biomarkers in the development of guidelines for efficient…
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
Results of the analysis of the candidate biomarkers in the appropriate type of
sample in the patient sample sets from all clinical centres.
Secondary outcome
N.a.
Background summary
There are several genomic, proteomic and molecular pathology biomarkers for
prostate cancer in development in commercial and in academic research
laboratories that may have the potential to improve identification of indolent
prostate cancer. Importantly, they may also be indicators of disease
progression during active surveillance. New technological developments allow
for the analysis of a considerable number of biomarkers simultaneously in a
standard set of clinically relevant biomaterials. The PROCABIO (Tailored
treatment of PROstate CAncer by BIOmarkers) project provides the unique
opportunity to translate a broad range of the most promising biomarkers for
prostate cancer that are currently looked upon by the industry as well as the
academic institutes being of interest to the clinical setting of active
surveillance.
Study objective
The following objectives have been defined for PROCABIO:
1. Integration of biomarkers in an updated and improved model for the
prediction of indolent prostate cancer.
2. Integration of biomarkers in the development of guidelines for efficient
strategies for active surveillance as a treatment
for indolent prostate cancer.
3. Delivery of validated biomarker tools that are easily applicable for high
throughput use in clinical and screening settings.
4. Establishment of the overall acceptance of active surveillance as a
treatment modality for indolent prostate cancer by
informing all stakeholders, including patients, clinicians, scientists and
policy makers.
Study design
Observational study.
Study burden and risks
The risk of health damage caused by trial participation is negligible.
's-Gravendijkwal 230
3015 CE Rotterdam
NL
's-Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients who decide to participate in PRIAS or are participating in PRIAS for less than 2 years are eligible. The inclusion criteria for PRIAS are the following:
1. Histologically proven adenocarcinoma of the prostate
2. Men should be fit for curative treatment
3. PSA-level at diagnosis <= 10 ng/mL
4. PSA density (PSA D) less than 0,2
5. Clinical stage T1C or T2
6. Adequate biopsy sampling (see 'biopsy protocol')
7. Gleason score 3+3=6
8. One or 2 biopsy cores invaded with prostate cancer
9. Participants must be willing to attend the follow-up visits
Exclusion criteria
The exclusion criteria for PRIAS are the following:
1. Men who can not or do not want to be irradiated or operated
2. A former therapy for 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 | NL26611.078.09 |