Clinical trial NCT02370992: I125 Brachytherapy After TURP
Official title: Prospective Multi-centre Study of Low-dose Rate Iodine125 (I-125) Prostate Brachytherapy Performed After Transurethral Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 3
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in acute and late urinary toxicity defined by International Prostate Specific Score and Common Terminology Criteria for Adverse Events v4.
timeFrame: Measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly
Secondary outcomes:
measure: Gastro-intestinal and sexual function
timeFrame: Measured at 1 mth.
measure: Gastro-intestinal and sexual function
timeFrame: Measured at 3 mth.
measure: Gastro-intestinal and sexual function
timeFrame: Measured at 6 mth.
measure: Gastro-intestinal and sexual function
timeFrame: Measured at 12 mth.
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust
Study officials:
References: