|- candidate number||8350|
|- NTR Number||NTR2475|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-aug-2010|
|- Secondary IDs||S07.103 / NL32105.078.10 METC Erasmus MC / CCMO|
|- Public Title||Prostate Cancer Molecular Medicine (PCMM).|
|- Scientific Title||Prostate Cancer Molecular Medicine (PCMM).|
|- hypothesis||Current methods of detecting the presence and/or prognosis of prostate cancer are not optimal. New markers will provide better detection and/or better methods to determine prognosis. |
In addition, there are currently no methods available to properly assess the response to treatment in patients with castration-resistant prostate cancer. Novel molecular imaging tools can provide an effective therapy response monitoring tool for these patients.
|- Healt Condition(s) or Problem(s) studied||Prostate cancer|
|- Inclusion criteria||Group 1:|
1. Planned to undergo prostate biopsies according to standard practice;
2. Signed informed consent.
1. cT1-3Nx-0Mx-0 prostate cancer;
2. Scheduled for radical prostatectomy according to standard practice;
3. Signed informed consent.
|- Exclusion criteria||Group 1 and group 2:|
1. Known allergy to contrast agents or sulphur hexafluoride micro bubbles;
2. Documented acute prostatitis or urinary tract infections;
3. Any clinically unstable cardiac condition within 7 days prior to contrast agent administration such as:
A. Evolving or ongoing myocardial infarction;
B. Typical angina at rest;
C. Significant worsening of cardiac symptoms;
D. Recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings);
E. Acute cardiac failure, class III/IV cardiac failure;
F. Severe cardiac rhythm disorders;
G. Right-to-left shunts;
H. Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome.
Group 2 only:
1. Renal insufficiency (GFR < 30 ml/min);
2. Severe cardiac condition;
3. Vulnerable for convulsions;
4. Presence of a pacemaker or other implants or clamps.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-sep-2010|
|- planned closingdate||1-sep-2012|
|- Target number of participants||400|
|- Interventions||Prospective blood, urine, and histology sampling and imaging.|
|- Primary outcome||Construction of a Dutch multicenter prospective biorepository for validation of biomarker and imaging products.|
|- Secondary outcome||1. Newly developed biomarkers and imaging tools that can improve the diagnosis, prognosis and therapy monitoring for prostate cancer;|
2. An IT infrastructure for the integration of the complex information from biomarker analysis and (molecular) imaging, next to individual clinical data and biobank data, allowing for the future development of a Clinical Decision Support System (CDSS) that optimizes clinical decision making.
|- Timepoints||Group 1: During visit for standard procedure for diagnostic prostate biopsies.
Group 2: Max. 8 weeks preoperative and 6-8 weeks post-operative.
|- Trial web site||www.pcmmproject.org|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. E.A.M. Schenk-Braat|
|- CONTACT for SCIENTIFIC QUERIES||Dr. E.A.M. Schenk-Braat|
|- Sponsor/Initiator ||Erasmus Medical Center, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) , University Medical Center Groningen (UMCG), University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, University Medical Center Groningen (UMCG), Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL), Center for Translational Molecular Medicine (CTMM), University Medical Center Nijmegen|
|- Brief summary||In Western men, prostate cancer is the most frequent malignancy and one of the major causes of cancer-related death. The incidence of this malignancy is rising due to screening. The Prostate Cancer Molecular Medicine (PCMM) project will address the two major clinical needs in prostate cancer:|
1. The reduction of overdiagnosis and overtreatment of this disease due to screening by biomarkers;
2. The improvement of therapy monitoring of advanced prostate cancer by targeting imaging.
The study population exists of men with an increased risk of prostate cancer that undergo prostate biopsies based on standard care criteria (group 1) and men with localized prostate cancer primarily to be treated with prostatectomy based on standard care criteria (group 2).
Additional serum and urine samples will be obtained for biobanking. MRI studies (group 2 only) and CEUS of the prostate will be performed. This implies an additional burden of approximately 2 hours for patients from group 2 and approximately 1 hour for patients from 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.
|- Main changes (audit trail)|
|- RECORD||19-aug-2010 - 9-sep-2010|