NCT01347320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

2.7 years

First QC Date

March 9, 2010

Last Update Submit

December 27, 2013

Conditions

Prostate Cancer

Keywords

Prostate cancerpreoperative stagingMRIFree surgical margins

Outcome Measures

Primary Outcomes (1)

  • Surgical margins

    The surgical margins are assessed by evaluating the pathological specimen

    30 days

Secondary Outcomes (4)

  • Surgical decision process

    30 days

  • Preoperative TNM classification

    1-4 weeks

  • Detection of Gleason grade 4 and 5

    30 days

  • Functional outcome

    1 year after prostatectomy

Study Arms (2)

No preoperative MRI

NO INTERVENTION

control arm of the study

MRI group

ACTIVE COMPARATOR

preoperative MRI

Other: Preoperative MRI

Interventions

Preoperative MRIOTHER

Preoperative staging

MRI group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients suitable for surgery.
  • Positive biopsy (Gleason grade \>3).
  • Informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0514, Norway

Location

Related Publications (2)

  • 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.

    PMID: 25813692DERIVED

  • 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.

    PMID: 25059766DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Erik Rud, MD

    Oslo University Hospital, Aker

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 9, 2010

First Posted

May 4, 2011

Study Start

November 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 30, 2013

Record last verified: 2013-12

Locations

NO(1)