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The value of MRI in active surveillance of prostate cancer.


- candidate number6450
- NTR NumberNTR2006
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2009
- Secondary IDsNL27911.091.09  MEC: CMO Arnhem Nijmegen
- Public TitleThe value of MRI in active surveillance of prostate cancer.
- Scientific TitleIncorporation of Multimodality Magnetic Resonance Imaging in the PRIAS study.
- ACRONYMMRI in PRIAS
- hypothesisIncorporation of multimodality MRI will improve patient selection and will lead to earlier detection of patients with progressive disease in active surveillance within the PRIAS study, thus increasing patient safety. In this way, active surveillance will be reliable in preventing overtreatment ( incontinence, impotence).
- Healt Condition(s) or Problem(s) studiedProstatic neoplasms
- Inclusion criteria1. Histologically proven adenocarcinoma of the prostate;
2. PSA 10 ng/ml and PSA density <0.2 ng/ml/ml;
3. TRUS-biopsy Gleason Score 6 (no 4 or 5 pattern);
4. TRUS-biopsy characteristics: < 2 cores involved;
5. Clinical stage T1C or T2;
6. Appropriate biopsy sampling (conform PRIAS protocol).
- Exclusion criteria1. Patients with known contradictions to MRI;
2. Patients with known contra-indications to Gadolinium based contrast agents;
3. Patients with previous therapy for prostate cancer;
4. Patients who can not or do not want to receive radiotherapy or radical prostatectomy;
5. Patient request for definitive curative intervention.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 14-sep-2009
- planned closingdate14-sep-2015
- Target number of participants80
- Interventions1. PCA3 testing;
2. Magnetic resonance imaging of the prostate;
3. Magnetic resonance imaging guided prostate;
4. Biopsy.
- Primary outcomeNumber of patients that are upgraded on basis of histology specimen Gleason score of initial and follow-up MRGB (at 2 months, 1 year and 4 years of follow-up) versus histology specimen Gleason score of initial and follow-up TRUSGB (at 1 and 4 years of follow-up). Timepoints 2 months, 1 year and 4 years.
- Secondary outcome1. The percentage of patients with cancers included in the PRIAS study that are visible on MRI. Timepoint: 4 years;
2. The percentage of patients with delayed interventions on patient request after incorporation of MRI in PRIAS. Timepoint: 4 years;
3. The percentage of patients with delayed interventions based upon progression within the first year of follow-up and in the last three years of follow-up. Timepoints: 1 year and 4 years;
4. Median progression free survival Timepoint: 4 years Disease specific mortality and overall mortality. Timepoint: 4 years;
5. The relation between PCA3 values and progression (an increase of 1 Gleason score on repeat biopsy) of low-grade prostate cancer. Timepoint 1 year and 4 years.
- TimepointsMainly after 2 months, one year and four years(=total follow-up) of folluw-up.
- Trial web siteN/A
- statusopen: patient inclusion
- 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 if the incorporation of Multimodality MRI including MRGB within the PRIAS study for low-risk low volume prostate cancer leads to a higher number of cancers that is upgraded by follow-up MRGB versus initial TRUSGB ( at 2 months, one year and four years of follow-up) in comparison to upgrading of cancers by follow-up TRUSGB versus initial TRUSGB ( at one and four years of follow-up).

Study population: Patients included in the PRIAS study Intervention All the patients will undergo active surveillance with TRUSGB, MRI and MRGB at 2 months ( not for TRUSGB), one year and four years of follow-up with further MRI diagnostics in between if necessary. A minimum of 19 visits, depending on the follow-up time, to the Radboud University Nijmegen medical centre, where TRUSGB, MRI and MRGB will be performed (6), and to the primary health care centre where the patients own urologist is based, to take venapunctions, digital rectal examinations and evaluations (13).
- Main changes (audit trail)
- RECORD10-sep-2009 - 12-okt-2009


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