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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving I125 brachytherapy | I125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I125 brachytherapy | Radiation | I125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice |
| Measure | Description | Time Frame |
|---|---|---|
| Change in acute and late urinary toxicity defined by International Prostate Specific Score and Common Terminology Criteria for Adverse Events v4. | This change will be measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly | Measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly |
| Measure | Description | Time Frame |
|---|---|---|
| Gastro-intestinal and sexual function | Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.) | Measured at 1 mth. |
| Gastro-intestinal and sexual function |
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Inclusion Criteria:
Prostate (cancer) related:
Exclusion Criteria:
Unable to give informed consent.
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Patients taking part will do so having chosen I125 brachytherapy as their chosen treatment for prostate cancer and will have previously undergone TURP
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)
| Measured at 3 mth. |
| Gastro-intestinal and sexual function | Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.) | Measured at 6 mth. |
| Gastro-intestinal and sexual function | Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.) | Measured at 12 mth. |