Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Clinical Impact of MR Imaging in Patients With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347320
• Other study ID #: OsloUH
• Status: Completed
• Phase: N/A
• First received: March 9, 2010
• Last updated: December 27, 2013
• Start date: November 2009
• Est. completion date: July 2012

Study information

• Verified date: December 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• All patients suitable for surgery.

• Positive biopsy (Gleason grade >3).

• Informed consent.

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Preoperative MRI
Preoperative staging

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical margins	The surgical margins are assessed by evaluating the pathological specimen	30 days	No
Secondary	Surgical decision process	Evaluated using questionaire	30 days	No
Secondary	Preoperative TNM classification	Based upon preoperative MRI	1-4 weeks	No
Secondary	Detection of Gleason grade 4 and 5		30 days	No
Secondary	Functional outcome	Evaluate the functional outcome in respect to erectile dysfunction.	1 year after prostatectomy	No