Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04773821
Status:
UNKNOWN
Last Update Posted:
2022-03-29
First Post:
2021-02-15
Brief Title:
Performance of Prostate MRI and Following Biopsy to Detect Prostate Cancer Recurrence After Focal Therapy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Performance of Prostate MRI and Targeted Biopsy to Detect Residual Prostate Cancer Following Focal Therapy
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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:
IRMProft
Brief Summary:
The management of localized prostate cancer remains controversial because of a risk of over diagnosis and over treatment Focal therapy represents an approach to improve the therapeutic ratio of prostate cancer treatments Focal therapy has been developed as minimally invasive procedure with the aim of providing equivalent oncological safety reduced toxicity and improved functional outcomes Multiparametric mp MRI Imaging may provide a reliable mean of monitoring for disease recurrence and has been suggested as the most accurate imaging tool currently available for systematic detection of recurrence pre-biopsy and preoperative mapping for an eventual salvage therapy However question about the performance of MRI and targeted biopsy in monitoring and defining successful therapy and follow up has been poorly evaluated Modalities standard biopsy ablation zone biopsy vs targeted biopsy and number of biopsies to be performed depending on the results of MRI remains unanswered due to a lack of available data
We hypothesize that the combination of MpMRI of the prostate with subsequent targeted biopsy TB may improve detection of prostate cancer and may therefore improve the follow-up of men after focal therapy FT to better identify patients that need a salvage treatment and when
We hypothesize that the combination of MpMRI of the prostate with subsequent targeted biopsy TB may improve detection of prostate cancer and may therefore improve the follow-up of men after focal therapy FT to better identify patients that need a salvage treatment and when
Detailed Description:
This trial is a multi-centric prospective and diagnostic study comparative not randomised The main objective is to evaluate the value of Multiparametric MRI MpMRI and targeted biopsy in detecting recurrence after focal treatment of prostate cancer PCa The secondary objectives all energy and according to the energy used are to describe the specific changes in prostate morphology after focal therapy normal presentation and recurrence in the treated and in the non-treated zone all energy and according to the energy usedto evaluate the accuracy of MpMRI in the detection of residual PCa in the treated zone in the whole gland to evaluate the performance of targeted biopsy and non targeted biopsy for the detection of prostate cancer recurrence to evaluate the combination of targeted biopsy and non targeted biopsy for the detection of prostate cancer recurrence to assess the number and amount of unnecessary non targeted biopsies taken during the follow up of men in focal therapy to describe the morbidity of prostate non-targeted and targeted biopsy number and severity of biopsy complications for the detection of prostate cancer recurrence to evaluate the impact of recurrence detection on patient management number and type of salvage treatmentto evaluate the post treatment PSA levels including density PSA nadir and its goal in detection recurrence to examine failures in order to learn potential future predictors of failure all energy and according to the energy used the initial location of the target on MRI and its Gleason gradeThe first objective of ancillary study is a central MRI lecture with 3 experts which will allow performance and inter-observer reproducibility to evaluate the percentage of cases that will be scored with agreement for concordant biopsy decision by the central radiology team and the site radiologist to determine on the pre-treatment MRI predictive criteria of success or failure for focal therapy according of the energy used and to propose recommendations for MRI interpretation after FT The second objective of ancillary study is a central pathology reading to evaluate the percentage of cases that will be scored with agreement on the Gleason score by the central pathologists and the site pathologist and to propose recommendations for histology interpretation post focal therapy The study population will consist of men with low and intermediate risk prostate cancer ISUP 1 and 2 who has already chosen to undergo focal treatment and be willing and able to undergo MpMRI with subsequent prostate biopsies as indicated Patients will be enrolled at baseline by an urologist in one of urology units listed as investigation center The focal treatment should take place no later than 3 months after inclusion visit The follow-up visits will be planned at 3 month6 month12 and 13 months after focal treatment consistently with patient usual care In this study all patients will have a MpMRI and MpMRI targeted biopsy in the presence of a lesion suggestive of recurrenceThe statistical analysis is to compare the positive biopsy rate between non targeted and targeted in subject as his own control with a 12-month relapse rate of 30 assuming 1825 positive with the standard method H0 and 2625 with the targeted method H1 and 15 of discordant pairs By simulation with a MacNemar test with a bilateral alpha risk of 5 and power of 90 we need 260 subjects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A01466-33 | OTHER | IDRCB | None |