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…
ID
Bron
Verkorte titel
Aandoening
prostate cancer, prostaatkanker
Ondersteuning
Department of Radiology Radboud University Nijmegen Medical Centre
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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).
Doel van het onderzoek
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).
Onderzoeksopzet
Mainly after 2 months, one year and four years(=total follow-up) of folluw-up.
Onderzoeksproduct en/of interventie
1. PCA3 testing;
2. Magnetic resonance imaging of the prostate;
3. Magnetic resonance imaging guided prostate;
4. Biopsy.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1893 |
NTR-old | NTR2006 |
CCMO | NL27911.091.09 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON33150 |