1. To construct a Dutch multicenter prospective biorepository for validation of biomarker and imaging products.2. To provide a Medical Technology Assessment (MTA) of newly developed biomarkers, contrast enhanced ultrasound and multimodality MR Iin…
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
1. Construction of a Dutch multicenter prospective biorepository for validation
of biomarker and imaging products.
Secondary outcome
1. Provision of a Medical Technology Assessment (MTA) of newly developed
biomarkers, contrast enhanced ultrasound and multimodality MRI in early and
advanced PCa for diagnosis and therapeutic decision making as compared to
current standard diagnostic techniques.
2. Initiation of a Clinical Decision Support System (CDSS) that optimizes
clinical decision making by integrating the complex information from biomarkers
and (molecular) imaging, next to individual clinical data in the clinical phase
of the disease.
Background summary
Prostate cancer 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.
Study objective
1. To construct a Dutch multicenter prospective biorepository for validation of
biomarker and imaging products.
2. To provide a Medical Technology Assessment (MTA) of newly developed
biomarkers, contrast enhanced ultrasound and multimodality MR Iin early and
advanced PCa for diagnosis and therapeutic decision making as compared to
current standard diagnostic techniques.
3. To initiate a Clinical Decision Support System (CDSS) that optimizes
clinical decision making by integrating the complex information from biomarkers
and (molecular) imaging, next to individual clinical data in the clinical phase
of the disease.
Study design
Prospective material sampling and documentation of clearly defined groups of
patients suspicious for prostate cancer and prostate cancer patients as well as
testing of novel imaging modalities.
Study burden and risks
Additional serum and urine samples will be obtained for biobanking.
Preoperatively, MRI studies and CEUS of the prostate will be performed in group
2. This implies an additional burden of 4,75 hours for patients in group 2 and
approximately 1/2 hour for patients in group 1. Improved imaging may benefit
the patient. The marker analysis will most likely not be of benefit to the
participating patients since results will be expected to become available only
after several years.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Group 1:
• planned to undergo prostate biopsies according to standard practice
• signed informed consent;Group 2:
• cT1-3Nx-0Mx-0 prostate cancer
• scheduled for radical prostatectomy according to standard practice
• signed informed consent
Exclusion criteria
Group 2 only:
• known allergy to contrast agents or sulphur hexafluoride micro bubbles
• documented acute prostatitis or urinary tract infections within 8 weeks prior to inclusion
• severe cardiac condition
• any clinically unstable cardiac condition within 7 days prior to contrast agent administration such
as:
- evolving or ongoing myocardial infarction
- typical angina at rest
- significant worsening of cardiac symptoms
- recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent
deterioration of ECG, laboratory or clinical findings)
- acute cardiac failure, class III/IV cardiac failure
- severe cardiac rhythm disorders
- right-to-left shunts
• known severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled
systemic hypertension or respiratory distress syndrome
• renal insufficiency (GFR < 30 ml/min)
• vulnerable for epilepsy
• presence of a pacemaker or other implants or clamps
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 | NL32105.078.10 |