Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT01347320
Brief Summary:
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.
Detailed Description:
Background:
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:
NCT01347320
Study Brief:
Protocol Section:
NCT01347320