Ignite Creation Date:
2025-12-18 @ 9:36 AM
Ignite Modification Date:
2025-12-23 @ 9:57 PM
Study NCT ID:
NCT06429878
Status:
None
Last Update Posted:
2024-05-28 00:00:00
First Post:
2024-05-21 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Long Term Effect of MRI Before Radical Prostatectomy.
Sponsor:
None
Organization:
Study Overview
Official Title:
The Long Term Effect of MRI Before Radical Prostatectomy.
Status:
None
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:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: