To validate two novel genomic biomarkers that provide information with respect to the presence of PCa, disease aggressiveness, and progression towards recurrent and metastatic disease.
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
- Predictive value of the novel genomic biomarker QUATTRO assessed in urine for
detecting relevant cancer in a diagnostic prostate biopsy.
- Predictive value of the novel genomic biomarkers QUATTRO assessed in urine
and PPI assessed in a biopsy for detecting relevant cancer in a RP specimen.
- Combined predictive value of the novel genomic biomarkers QUATTRO and PPI
with MRI and histological biopsy markers for detecting relevant cancer in a RP
specimen.
Secondary outcome
- Modelled QUATTO and PPI data in decision support tools for prostate cancer.
- Outcome on between-sites variability of the performance of the QUATTRO and
PPI assays.
Background summary
Prostate cancer (PCa) is the most frequent non-cutaneous cancer in men. To
prevent over-treatment in localized disease prognostic markers are needed.
Since metastasized disease is always eventually lethal, prognostic and
predictive markers and new therapeutic targets need study. The QUATTRO and PPI
markers developed in Prostate Cancer Molecular Medicine (PCMM) can contribute
as solutions for this clinical need and will be tested in this project.
Study objective
To validate two novel genomic biomarkers that provide information with respect
to the presence of PCa, disease aggressiveness, and progression towards
recurrent and metastatic disease.
Study design
Retrospective and prospective material sampling and documentation of clearly
defined groups of patients suspicious for PCa and PCa patients.
Study burden and risks
Per patient additional serum and urine samples will be obtained once for
biobanking on top of the clinical diagnostic routine including MRI. MRI studies
of the prostate are performed in patients for assessment of men with increased
risk for PCa according to the Rotterdam Prostate Cancer Risk Calculator (RPCRC,
www.prostatecancer-riskcalculator.com ). Improved imaging may benefit the
patient, e.g. for surgeons preference how to perform steps during a radical
prostatectomy (RP). The marker analysis will most likely not be of benefit to
the participating patients since results will be expected to become available
only after a few years.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Retrospective cohort
- Participants of Group 1 and/or 2 in PCMM.
- Obtained informed consent in PCMM.;Prospective cohort
- Men >= 18 years.
- Planned to undergo prostate biopsies according to standard practice.
- Signed informed consent.
Exclusion criteria
Prospective cohort
- Documented acute prostatitis or urinary tract infections within 8 weeks prior to inclusion.
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 | NL53610.078.15 |