I125 Brachytherapy After TURP

Cancer Clinical Trial

Official title:

Prospective Multi-centre Study of Low-dose Rate Iodine125 (I-125) Prostate Brachytherapy Performed After Transurethral Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370992
• Other study ID #: CO11/9837
• Status: Completed
• Start date: July 1, 2011
• Est. completion date: July 1, 2016

Study information

• Verified date: August 2019
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• WHO performance status 0-1

• No contra-indication for anaesthesia

• No history of irradiation of the pelvis

• No other oncologic malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient is disease free for at least 5 years.

• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;

Prostate (cancer) related:

• Histologically proven prostate cancer (adenocarcinoma) of low or intermediate risk following the D'Amico classification.

• Prostate volume < 50 cc as measured on transrectal ultrasound

• Neo-adjuvant antiandrogen hormonal treatment is permitted to downsize the prostate volume or to cover waiting time till brachytherapy procedure. No adjuvant hormonal treatment is permitted.

• History of TransUrethral Resection of the prostate (TURp), performed at least 3 months before the brachytherapy procedure.

• Rim of prostate tissue of at least 1 cm around the post-TURp urethral defect at thepostero-lateral sides of the prostate

• Absence of significant TURp-induced urinary incontinence

• IPSS <15

Exclusion Criteria:

• Locally advanced (stage T3 or T4 , or metastatic (stage N+ or M+) prostate cancer High grade tumours defined by Gleason score 8 or above Co-morbidity which would exclude the patient from a transperineal implant procedure.

Unable to give informed consent.

Related Conditions & MeSH terms

• Cancer

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
United Kingdom	The Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.
Secondary	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 3 mth.
Secondary	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.
Secondary	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.