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De toegevoegde waarde van magnetic resonance imaging in detectie van prostaatkanker.


- candidate number6456
- NTR NumberNTR2008
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-sep-2009
- Secondary IDsNL26080.091.08  MEC: CMO Arnhem Nijmegen
- Public TitleDe toegevoegde waarde van magnetic resonance imaging in detectie van prostaatkanker.
- Scientific TitleThe 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.
- ACRONYMMRI in detectie van prostaatkanker
- hypothesisMRI 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) studiedProstate cancer, Magnetic resonance imaging (MRI)
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 10-jan-2009
- planned closingdate10-jan-2011
- Target number of participants80
- Interventions1. MRI examination of the prostate;
2. MR guided prostate biopsy;
3. MR ultrasound Fusion guided prostate biopsy;
4. Transrectal Ultrasound guided prostate biopsy.
- Primary outcomeDetection rates of MRGB compared to a second or later TRUSGB examination. Timepoint:8 weeks.
- Secondary outcome1. 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.
- Timepoints8 weeks after inclusion. After inclusion of all patients necessary.
- Trial web siteN/A
- statusplanned
- 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
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsN/A
- Brief summaryObjective: 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.

Secondary Objectives: To determine the percentage of patients upgraded for MRGB compared to TRUSGB. To determine detection rates of MRUSFGB.

Study design: A prospective cohort study.

Study population: 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.

Intervention: 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)
- RECORD11-sep-2009 - 12-okt-2009


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