The Long Term Effect of MRI Before Radical Prostatectomy.

NCT ID: NCT06429878

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-01

Study Completion Date

2026-05-19

Brief Summary

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A randomized clinical trial conducted by Oslo University Hospital between 2010 and 2012 included 438 patients with prostate cancer to the non-MRI group (216) or the MRI group (222) before robot-assisted radical prostatectomy (RALP). The primary endpoint was to compare the nerve-sparing surgery types and the proportion of positive surgical margins (PSM) in each group. The MRI group underwent more non-nerve sparing surgery, whereas the proportion of PSM was similar in both groups (p=0.4) \[1\]. Since the long-term effects of preoperative MRI are unknown, we aimed to assess the variations in the long-term functional and oncological outcomes between the groups.

Detailed Description

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The aim of this study was to evaluate the oncological and functional outcomes in a 12-year follow-up after RALP in patients preoperatively randomized to no-MRI or MRI.

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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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomized to either MRI or no-MRI before radical prostactomy
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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no-MRI

received no MRI before prostatectomy

Group Type ACTIVE_COMPARATOR

Biparametric prostatic MRI

Intervention Type DIAGNOSTIC_TEST

MRI

received MRI before prostatectomy

Group Type EXPERIMENTAL

Biparametric prostatic MRI

Intervention Type DIAGNOSTIC_TEST

Interventions

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Biparametric prostatic MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Prostate cancer scheduled for prostatectomy. All participated in the previous RCT

Exclusion Criteria

Patients who did not sign the consent paper for any reason or did not accept the study premises.

Patients who underwent MRI prior to randomization. Patents who withdrew their consent for any reason during the study.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erik Rud

Principal Investigator

Responsibility Role 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.

Reference Type BACKGROUND
PMID: 25813692 (View on PubMed)

Related Links

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Other Identifiers

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248365

Identifier Type: -

Identifier Source: org_study_id

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