The value of MRI in active surveillance of prostate cancer.
Recruiting
- Conditions
- prostate cancer, prostaatkanker
- Registration Number
- NL-OMON23734
- Lead Sponsor
- C.M.A. Hoeks, MDDepartment of Radiology Radboud University Nijmegen Medical Centre
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Histologically proven adenocarcinoma of the prostate;
2. PSA ¡Ü 10 ng/ml and PSA density <0.2 ng/ml/ml;
Exclusion Criteria
1. Patients with known contradictions to MRI;
2. Patients with known contra-indications to Gadolinium based contrast agents;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber 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.<br><br>
- Secondary Outcome Measures
Name Time Method 1. The percentage of patients with cancers included in the PRIAS study that are visible on MRI. Timepoint: 4 years;<br /><br>2. The percentage of patients with delayed interventions on patient request after incorporation of MRI in PRIAS. Timepoint: 4 years;<br /><br>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;<br /><br>4. Median progression free survival Timepoint: 4 years<br>Disease specific mortality and overall mortality. Timepoint: 4 years;<br /><br>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.<br>