Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erik Rud, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01347320
First received: March 9, 2010
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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 Intervention
Prostate Cancer
Other: Preoperative MRI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Impact of MR Imaging in Patients With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Surgical margins [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The surgical margins are assessed by evaluating the pathological specimen


Secondary Outcome Measures:
  • Surgical decision process [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Evaluated using questionaire

  • Preoperative TNM classification [ Time Frame: 1-4 weeks ] [ Designated as safety issue: No ]
    Based upon preoperative MRI

  • Detection of Gleason grade 4 and 5 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Functional outcome [ Time Frame: 1 year after prostatectomy ] [ Designated as safety issue: No ]
    Evaluate the functional outcome in respect to erectile dysfunction.


Enrollment: 400
Study Start Date: November 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No preoperative MRI
control arm of the study
Active Comparator: MRI group
preoperative MRI
Other: Preoperative MRI
Preoperative 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347320

Locations
Norway
Oslo University Hospital
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Erik Rud, MD Oslo University Hospital, Aker
  More Information

No publications provided

Responsible Party: Erik Rud, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01347320     History of Changes
Other Study ID Numbers: OsloUH
Study First Received: March 9, 2010
Last Updated: December 27, 2013
Health Authority: Norway: Ethics Committee

Keywords provided by Oslo University Hospital:
Prostate cancer
preoperative staging
MRI
Free surgical margins

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014