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Clinical Impact of MR Imaging in Patients With Prostate Cancer

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Clinical Impact of MR Imaging in Patients With Prostate Cancer


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) if preoperative MRI can determine tumor localization, size, 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.

Inclusion Criteria

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

- Patents who want to withdraw for any reason during the study.

- Patients with contraindications to MRI (pacemaker, claustrophobia etc) and/or

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Surgical margins

Outcome Description:

The surgical margins are assessed by evaluating the pathological specimen

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Erik Rud, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital, Aker


Norway: Ethics Committee

Study ID:




Start Date:

November 2009

Completion Date:

July 2012

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • preoperative staging
  • MRI
  • Free surgical margins
  • Prostatic Neoplasms