The Long Term Effect of MRI Before Radical Prostatectomy.

NCT06429878 | Active Not Recruiting

• 1 other identifier: 248365
• Study Type: interventional
• Target: 438
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

disease-free survival; overall survival; functional outcomes

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  The difference between patients randomized to MRI or no-MRI

  12-years after surgery

Secondary Outcomes (4)

• Overall survival (OS)

  12-years after surgery

• Erectile dysfunction

  After 12 years

• The impact of the length of positive surgical margin and Gleason score upon DFS.

  After 12 years

• The impact of MRI variables for predicting PSM, PSA recurrence and OS

  After 12 years

Study Arms (2)

no-MRI

ACTIVE COMPARATOR

received no MRI before prostatectomy

Diagnostic Test: Biparametric prostatic MRI

MRI

EXPERIMENTAL

received MRI before prostatectomy

Diagnostic Test: Biparametric prostatic MRI

Interventions

Biparametric prostatic MRI DIAGNOSTIC_TEST

MRI; no-MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Related Publications (1)

• 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: 25813692 BACKGROUND

Related Links

• A link to the original study

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Erik Rud, MD,PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients were randomized to either MRI or no-MRI before radical prostactomy

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: December 1, 2009
• Primary Completion: June 30, 2012
• Study Completion: May 19, 2026
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share