Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Preoperative MRI
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, preoperative staging, MRI, Free surgical margins
Eligibility 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.
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No preoperative MRI
MRI group
Arm Description
control arm of the study
preoperative MRI
Outcomes
Primary Outcome Measures
Surgical margins
The surgical margins are assessed by evaluating the pathological specimen
Secondary Outcome Measures
Surgical decision process
Evaluated using questionaire
Preoperative TNM classification
Based upon preoperative MRI
Detection of Gleason grade 4 and 5
Functional outcome
Evaluate the functional outcome in respect to erectile dysfunction.
Full Information
NCT ID
NCT01347320
First Posted
March 9, 2010
Last Updated
December 27, 2013
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01347320
Brief Title
Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer
Official Title
Clinical Impact of MR Imaging in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, preoperative staging, MRI, Free surgical margins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No preoperative MRI
Arm Type
No Intervention
Arm Description
control arm of the study
Arm Title
MRI group
Arm Type
Active Comparator
Arm Description
preoperative MRI
Intervention Type
Other
Intervention Name(s)
Preoperative MRI
Intervention Description
Preoperative staging
Primary Outcome Measure Information:
Title
Surgical margins
Description
The surgical margins are assessed by evaluating the pathological specimen
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Surgical decision process
Description
Evaluated using questionaire
Time Frame
30 days
Title
Preoperative TNM classification
Description
Based upon preoperative MRI
Time Frame
1-4 weeks
Title
Detection of Gleason grade 4 and 5
Time Frame
30 days
Title
Functional outcome
Description
Evaluate the functional outcome in respect to erectile dysfunction.
Time Frame
1 year after prostatectomy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Rud, MD
Organizational Affiliation
Oslo University Hospital, Aker
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0514
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25813692
Citation
Rud E, Baco E, Klotz D, Rennesund K, Svindland A, Berge V, Lundeby E, Wessel N, Hoff JR, Berg RE, Diep L, Eggesbo HB, Eri LM. Does preoperative magnetic resonance imaging reduce the rate of positive surgical margins at radical prostatectomy in a randomised clinical trial? Eur Urol. 2015 Sep;68(3):487-96. doi: 10.1016/j.eururo.2015.02.039. Epub 2015 Mar 23.
Results Reference
derived
PubMed Identifier
25059766
Citation
Rud E, Klotz D, Rennesund K, Baco E, Johansen TE, Diep LM, Svindland A, Eri LM, Eggesbo HB. Preoperative magnetic resonance imaging for detecting uni- and bilateral extraprostatic disease in patients with prostate cancer. World J Urol. 2015 Jul;33(7):1015-21. doi: 10.1007/s00345-014-1362-x. Epub 2014 Jul 25.
Results Reference
derived
Learn more about this trial
Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer
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