Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-28 @ 11:14 AM
Study NCT ID:
NCT02370992
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2015-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
I125 Brachytherapy After TURP
Sponsor:
The Leeds Teaching Hospitals NHS Trust
Organization:
Study Overview
Official Title:
Prospective Multi-centre Study of Low-dose Rate Iodine125 (I-125) Prostate Brachytherapy Performed After Transurethral Resection
Status:
COMPLETED
Status Verified Date:
2019-08
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:
Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this technique in patients who have had a previous transurethral resection of the prostate gland (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience when the technique was being developed in the 1980s suggested that there was a higher incidence of urinary incontinence after brachytherapy if there had been a previous TURP. It is however clear that with increasing experience many centres offer this treatment to patients who have had previous TURP, using various parameters to select patients including time from the TURP and persence or absence of a significant cavity within the gland on MRI scanning. There has been no systematic study of I125 brachytherapy after TURP in the current era which might address and inform the practice for future patient. Hence this study is designed to formally assess the safety of I125 brachytherapy after previous TURP.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: