Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01347320|
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : December 30, 2013
The investigators want to evaluate if preoperative MRI improves the surgical results, especially in respect to surgical margins. The impact on the surgical procedure will be evaluated.
In addition the investigators will examine the accuracy of tumor detection, localization and staging.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Preoperative MRI||Not Applicable|
During the last two decades, Magnetic Resonance Imaging (MRI) of the prostate has evolved to become a promising tool in preoperative evaluation of prostate cancer. Several studies have evaluated the radiological and histopathological correlation. However, the sensitivity and specificity in regard to staging have shown wide ranges and poor reproducibility. These discrepancies can be explained by difference in patient selection, MRI methods, and criteria used for diagnosis. More studies are therefore needed to evaluate the clinical impact of preoperative MRI in patients with prostate cancer.
Aims of the study:
To evaluate 1) detection rate of tumor 1-3 (tumor 1 = index tumor), size of tumor 1-3, possible extraprostatic extension and predict presence of Gleason grade 4 and 5 tumor, 2) the influence of preoperative MRI on the surgical decision process with respect to the operative procedure for removal of the gland and pelvic lymph node dissection, and 3) the impact of preoperative MRI on the rate of positive surgical margins and functional results.
Material and method:
A prospective study including 400 consecutive patients referred to robot assisted laparoscopic prostatectomy randomised to preoperative MRI (intervention group) and no MRI (control group). The prostatectomy specimens will be histopathologically examined, and TNM classification will be performed according to 2002 AJCC standard.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Impact of MR Imaging in Patients With Prostate Cancer|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
No Intervention: No preoperative MRI
control arm of the study
Active Comparator: MRI group
Other: Preoperative MRI
- Surgical margins [ Time Frame: 30 days ]The surgical margins are assessed by evaluating the pathological specimen
- Surgical decision process [ Time Frame: 30 days ]Evaluated using questionaire
- Preoperative TNM classification [ Time Frame: 1-4 weeks ]Based upon preoperative MRI
- Detection of Gleason grade 4 and 5 [ Time Frame: 30 days ]
- Functional outcome [ Time Frame: 1 year after prostatectomy ]Evaluate the functional outcome in respect to erectile dysfunction.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347320
|Oslo University Hospital|
|Oslo, Norway, 0514|
|Principal Investigator:||Erik Rud, MD||Oslo University Hospital, Aker|