Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Preoperative MRI

• Registration Number: NCT01347320
• Lead Sponsor: Oslo University Hospital

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2011-05-03
• Study First Posted: 2011-05-04
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-27
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients who do not sign the consent paper for any reason or do not accept the study premises.
• Patents who want to withdraw for any reason during the study.
• Patients with contraindications to MRI (pacemaker, claustrophobia etc) and/or surgery.
• Patients who have undergone a high quality MRI examination of the prostate at another radiological center. In this situation the MR examination is evaluated together with the surgeon but the patient is not included in the study. (In case of a low quality examinations, we will disregard the findings, and include the patient).
• If the surgeon finds it unacceptable to perform RALP without MRI, because of various reasons (eg. patient demand, too high risk etc) the patient will not be included in the study.
• If preoperative MRI reveals extensive tumor invasion into adjacent organ (T4) or skeletal metastases (M1), as these cancer stadiums do not benefit from RALP.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI group	Preoperative MRI	preoperative MRI

Primary Outcome Measures

Name	Time	Method
Surgical margins	30 days	The surgical margins are assessed by evaluating the pathological specimen

Secondary Outcome Measures

Name	Time	Method
Surgical decision process	30 days	Evaluated using questionaire
Detection of Gleason grade 4 and 5	30 days
Functional outcome	1 year after prostatectomy	Evaluate the functional outcome in respect to erectile dysfunction.
Preoperative TNM classification	1-4 weeks	Based upon preoperative MRI

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway