No registrations found.
ID
Source
Brief title
Health condition
prostate cancer, prostaatkanker
Sponsors and support
Department of Radiology Radboud University Nijmegen Medical Centre
Intervention
Outcome measures
Primary outcome
Number 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 outcome
1. 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 ¡Ý1 Gleason score on repeat biopsy) of low-grade prostate cancer. Timepoint 1 year and 4 years.
Background summary
Objective: 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).
Study objective
Incorporation 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).
Study design
Mainly after 2 months, one year and four years(=total follow-up) of folluw-up.
Intervention
1. PCA3 testing;
2. Magnetic resonance imaging of the prostate;
3. Magnetic resonance imaging guided prostate;
4. 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. Histologically proven adenocarcinoma of the prostate;
2. PSA ¡Ü 10 ng/ml and PSA density <0.2 ng/ml/ml;
3. TRUS-biopsy Gleason Score ¡Ü 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 criteria
1. 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.
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 | NL1893 |
| NTR-old | NTR2006 |
| CCMO | NL27911.091.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON33150 |