Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06429878 |
| Other study ID # |
248365 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2009 |
| Est. completion date |
May 19, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Oslo University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 ≥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
