Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04891536
Status:
RECRUITING
Last Update Posted:
2021-05-18
First Post:
2021-05-09
Brief Title:
Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy
Sponsor:
Ignacio Puche Sanz
Organization:
University Hospital Virgen de las Nieves
Study Overview
Official Title:
Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy
Status:
RECRUITING
Status Verified Date:
2021-05
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:
CRIOAND2021
Brief Summary:
The main objective of this project is to establish a shared comprehensive and systematic protocol for a multicenter prospective registry of patients undergoing salvage cryoablation of the prostate SCAP
Our study hypothesis is that SCAP constitutes an effective and safe approach to treat local prostate cancer recurrence after brachytherapy or external beam radiation therapy EBRT
Our study hypothesis is that SCAP constitutes an effective and safe approach to treat local prostate cancer recurrence after brachytherapy or external beam radiation therapy EBRT
Detailed Description:
Salvage cryoablation of the prostate has been proposed as an alternative to salvage radical prostatectomy as it has a potentially lower risk of morbidity and equal efficacy A recent systematic review assessed a total of 32 studies of SCAP 5513 patients The overwhelming majority of patients 93 received whole-gland SCAP The adjusted pooled analysis for 2-year BCR-free survival for SCAP was 6749 95 CI 6168-7281 and for 5-year BCR-free survival was 5025 95 CI 4410-5640
Nevertheless the evidence base relating to the use of SCAP is poor with significant uncertainties relating to long-term oncological outcomes One of the main limitations when these studies are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy The vast majority only refer to biochemical-free survival as end point thus limiting interpretation of real oncological performance of this technique Furthermore side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting
Due to this lack of evidence the EAU 2021 Guidelines recommend that SCAP should only be performed in selected patients in experienced centres as part of a clinical trial or well-designed prospective cohort study
Nevertheless the evidence base relating to the use of SCAP is poor with significant uncertainties relating to long-term oncological outcomes One of the main limitations when these studies are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy The vast majority only refer to biochemical-free survival as end point thus limiting interpretation of real oncological performance of this technique Furthermore side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting
Due to this lack of evidence the EAU 2021 Guidelines recommend that SCAP should only be performed in selected patients in experienced centres as part of a clinical trial or well-designed prospective cohort study
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?:
False
Is an FDA AA801 Violation?:
None