Incorporation of Multimodality Magnetic Resonance Imaging in the PRIAS study

Completed

Conditions: prostate cancer prostate carcinoma
10036958

Registration Number: NL-OMON33150

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

• Histologically proven adenocarcinoma of the prostate
• PSA <= 10 ng/ml and PSA density <0.2 ng/ml/ml
• TRUS-biopsy Gleason Score <= 6 (no 4 or 5 pattern), TRUS-biopsy
characteristics: < 2 cores involved
• Clinical stage T1C or T2
• Appropriate biopsy sampling conform PRIAS study

Exclusion Criteria

• Patients with known contradictions to MRI
• Patients with known contra-indications to Gadolinium based contrast agents.
• Patients with previous therapy for prostate cancer.
• Patients who can not or do not want to receive curative treatment in form of radiotherapy or radical prostatectomy
• Patient request for definitive curative intervention

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the number of patients with a positive difference<br /><br>in Gleason grade (upgrading) of follow-up MRGB versus inclusion TRUSGB<br /><br>(expected to be 22% or higher in first year of follow-up and hopefully lower at<br /><br>the end of the first year and in the fourth year of follow-up) versus the<br /><br>number of patients with a positive difference in Gleason grade (upgrading) of<br /><br>repeat TRUS-GB versus inclusion TRUS-GB (expected round 12% in first year of<br /><br>follow-up and hopefully lower at the end of the first year and in the fourth of<br /><br>follow-up). This maij study parameter will be determined at baseline ( 2<br /><br>months), and at 1 and four years of follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include:<br /><br>The number of cancers included in the PRIAS study that are visible on MRI.<br /><br>The number of delayed interventions based on patient request after<br /><br>incorporation of MRI.<br /><br>Other study parameters are the mean progression free survival, the disease<br /><br>specific mortality and overall mortality, the incidence of (lymfogenic)<br /><br>metastasis in monitored population, the correlation of PCA3 values with<br /><br>progression of low-grade prostate cancer</p><br>