No registrations found.
ID
Source
Brief title
Health condition
prostate cancer detection, diagnose prostaatkanker
Sponsors and support
Department of Radiology
Intervention
Outcome measures
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.
Background 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.
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¡Ý4 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.
Study objective
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.
Study design
8 weeks after inclusion. After inclusion of all patients necessary.
Intervention
1. MRI examination of the prostate;
2. MR guided prostate biopsy;
3. MR ultrasound Fusion guided prostate biopsy;
4. Transrectal Ultrasound guided prostate biopsy.
Postadres:
UMC St Radboud
Afdeling Radiologie, 667
Postbus 9101
C.M.A. Hoeks
Radboud Universitair Medisch Centrum Nijmegen Afdeling Radiologie
Postadres:
UMC St Radboud
Afdeling Radiologie, 667
Postbus 9101
Nijmegen 6500 HB
The Netherlands
+31 (0)243616707
C.Hoeks@rad.umcn.nl
Postadres:
UMC St Radboud
Afdeling Radiologie, 667
Postbus 9101
C.M.A. Hoeks
Radboud Universitair Medisch Centrum Nijmegen Afdeling Radiologie
Postadres:
UMC St Radboud
Afdeling Radiologie, 667
Postbus 9101
Nijmegen 6500 HB
The Netherlands
+31 (0)243616707
C.Hoeks@rad.umcn.nl
Inclusion criteria
1. PSA¡Ý4.0 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1894 |
| NTR-old | NTR2008 |
| CCMO | NL26080.091.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON32545 |