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Completed

NCT Number: NCT01347320

Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0514, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative MRI

Other

Preoperative staging

Primary outcomes

  1. Surgical margins

    Time frame: 30 days

    The surgical margins are assessed by evaluating the pathological specimen

Secondary outcomes

  1. Surgical decision process

    Time frame: 30 days

    Evaluated using questionaire

  2. Preoperative TNM classification

    Time frame: 1-4 weeks

    Based upon preoperative MRI

  3. Detection of Gleason grade 4 and 5

    Time frame: 30 days

  4. Functional outcome

    Time frame: 1 year after prostatectomy

    Evaluate the functional outcome in respect to erectile dysfunction.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Clinical Impact of MR Imaging in Patients With Prostate Cancer

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 4, 2011
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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