|- candidate number||6456|
|- NTR Number||NTR2008|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-sep-2009|
|- Secondary IDs||NL26080.091.08 MEC: CMO Arnhem Nijmegen|
|- Public Title||De toegevoegde waarde van magnetic resonance imaging in detectie van prostaatkanker.|
|- Scientific Title||The added value of MRI for detection of prostate cancer: validation with MR guided biopsies, fusion of MRI and transrectal ultrasound guided biopsies and TRUS guided biopsies.|
|- ACRONYM||MRI in detectie van prostaatkanker|
|- hypothesis||MRI leads to higher prostate cancer detection: MR guided prostate biopsy and MR-ULtrasound Fusion Guided prostate biopsy will yield higher detection rates in comparison to Transrectal Ultrasound guided prostate biopsy.|
|- Healt Condition(s) or Problem(s) studied||Prostate cancer, Magnetic resonance imaging (MRI) |
|- Inclusion criteria||1. PSA¡İ4.0 ng/ml;|
2. One or more previous negative TRUS guided prostate biopsies;
3. Last TRUS guided biopsy should be within one year ago.
|- Exclusion criteria||1. Patients with known contradictions to MRI;|
2. Patients with known contra-indications to Gadolinium based contrast agents;
3. Patients with previous radiotherapy, hormonal therapy or local treatment of the prostate;
4. Patients with histological prove of prostate cancer;
5. Patients with a known restricted renal function ( MDRD-GFR value < 30 ml/min/1.73m2) as contraindication for use of intravenous Gadolinium contrast.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||10-jan-2009|
|- planned closingdate||10-jan-2011|
|- Target number of participants||80|
|- Interventions||1. MRI examination of the prostate;|
2. MR guided prostate biopsy;
3. MR ultrasound Fusion guided prostate biopsy;
4. Transrectal Ultrasound guided prostate biopsy.
|- Primary outcome||Detection rates of MRGB compared to a second or later TRUSGB examination. Timepoint:8 weeks.|
|- Secondary outcome||1. Detection rate of MRUSFGB. Timepoint: 8 weeks;|
2. Percentage of patients upgraded(with an increase of one point in Gleason score on MRGB and MRUSFGB compared tot TRUSGB) by MRGB and MRUSFGB Gleason score respectively compared to TRUSGB Gleason score. Timepoint: 8 weeks.
|- Timepoints||8 weeks after inclusion. After inclusion of all patients necessary.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| C.M.A. Hoeks|
|- CONTACT for SCIENTIFIC QUERIES|| C.M.A. Hoeks|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre, Department of Radiology|
(Source(s) of Monetary or Material Support)
|- Brief summary||Objective:
To determine detection rates of MRGB comparing to TRUSGB and MRUSFGB within patients who are at risk for prostate cancer but have no histological prove of prostate cancer, and who underwent at least one negative TRUSGB.|
To determine the percentage of patients upgraded for MRGB compared to TRUSGB.
To determine detection rates of MRUSFGB.
Study design: A prospective cohort study.
Patients who underwent at least one negative TRUSGB with a PSA¡İ4 and who are suspected of having prostate cancer without having histological proof of prostate cancer.
Patients will undergo a multimodality MRI consisting of anatomic T2 weighted MRI (T2W), Dynamic Contrast enhanced MRI (DCE) and Diffusion weighted (DWI) MRI. During a second visit a 10 core standard TRUSGB will be taken. Ultrasound images will be fused with processed MR images. After TRUSGB, the examiner will switch to the Fusion mode within the same examination and 2 cores at MRUSFGB of each tumor suspected region (TSR) will be taken up to a maximum of 4 cores ( maximum of 2 TSR¡¯s). Deze eerste sessie is dus puur wetenschap, c.q. voor de patienten die specifiek voor MRI biopten komen ¡°voor niets¡±After 4 weeks the patient will undergo MRGB (maximum of 2 cores of each TSR up to a maximum of 4 cores). All specimens will be examined by one specialised pathologist. In each patient one TRUSGB, one MRUSFGB and one MRGB procedure will be performed.
|- Main changes (audit trail)|
|- RECORD||11-sep-2009 - 12-okt-2009|