Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429878
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-21
Brief Title:
The Long Term Effect of MRI Before Radical Prostatectomy
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
The Long Term Effect of MRI Before Radical Prostatectomy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 p04 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:
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 02ngml 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 andor 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
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 02ngml 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None