The Long Term Effect of MRI Before Radical Prostatectomy.
NCT ID: NCT06429878
Last Updated: 2024-05-28
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
438 participants
INTERVENTIONAL
2009-12-01
2026-05-19
Brief Summary
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Detailed Description
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Material: a total of 438 consecutive patients were referred to RALP. Of these, 222 were randomized to preoperative MRI (intervention group), and 216 were randomized to no MRI (control group). All underwent radical prostatectomy between 2010 and 2012.
Study design: An experimental interventional study with 12-years follow-up
Endpoints: PSA recurrence (PSA ≥0.2ng/ml) Predictors for PSA recurrence (PSM, DÁmico risk group, Gleason score, T-stage) Overall survival (OS) Predictors for OS (PSM, DÁmico risk group, Gleason score, T-stage) MRI predictors for PSM, PSA recurrence and OS
Erectile function (IEEF-5) and urinary continence (IPSS-10) Urinary incontinence rates (≥1daily pads)
Statistics: Before RALP, included patients were randomized to the i) non-MRI group and ii) MRI-group. Kaplan Meier curves express the RFS and OS in the two groups, and the Log-rank test assesses any difference. Cox regression analyses is used to calculate the effect of MRI (Hazard ratios with 95% CIs). Chi-square test is used to assess the difference in incontinence rates, and the Mann-Whitney U test for assessing the difference in median IIEF-5 and IPSS-10 scores. Binary and Cox regression analysis is used to assess the predictive value of a positive surgical margin on PSA recurrence, and the effect of MRI variables in predicting RFS and OS (ADC, tumor volume, and radiological T-classification).
Data collection and handling of data: All patients were included in the study "Clinical impact of MRI in patients with prostate cancer." The urological and/or oncological clinic have followed these patients as part of routine clinical practice. Relevant clinical data are recorded in the "Radical prostatectomy registry ." All patients have already answered appropriate questionnaires during their regular follow-up.
PhD project: The study is a PhD project for radiologist Daniyal Noor at Oslo University Hospital
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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no-MRI
received no MRI before prostatectomy
Biparametric prostatic MRI
MRI
received MRI before prostatectomy
Biparametric prostatic MRI
Interventions
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Biparametric prostatic MRI
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Patients who underwent MRI prior to randomization. Patents who withdrew their consent for any reason during the study.
18 Years
MALE
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Erik Rud
Principal Investigator
Principal Investigators
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Erik Rud, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
References
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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.
Related Links
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A link to the original study
Other Identifiers
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248365
Identifier Type: -
Identifier Source: org_study_id
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