I125 Brachytherapy After TURP

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Radiation: I125 brachytherapy

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • The Leeds Teaching Hospitals Nhs Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients taking part will do so having chosen I125 brachytherapy as their chosen treatment for prostate cancer and will have previously undergone TURP

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CO11/9837