RecruitingACTRN12619000971134

ERUPT Trial: Urethral scarring after radiation treatment for prostate cancer

ERUPT Trial: External beam Radiotherapy and Urethral strictures in Prostate cancer Treatment

Sponsor

Icon Cancer Foundation

Enrollment

350 participants

Start Date

Aug 26, 2020

Study Type

Observational

Conditions

Urethral Strictures Prostate Cancer

Summary

This study will aim to measure the incidence of urethral strictures that develop after external beam radiotherapy for prostate cancer. Who is it for? You may be eligible for this study if you are an adult with prostate cancer who is undergoing radiotherapy treatment at Icon Cancer Centre Toowoomba QLD, Australia. Study details All participants will need to do is attend an assessment session 6 weeks following the end of radiation therapy treatment and then every 6 months for 5 years. This assessment will involve surveys and a urine flow test that is performed in the clinic. This flow test involves urinating into a flow meter to measure urine flow. It is non-invasive and only takes five to ten minutes to complete. It is hoped that the results from this study will help guide future radiotherapy treatment regimes and aid in the early detection of urethral strictures post-radiotherapy. Thus, leading to a reduction in invasive procedures and decreased overall morbidity. It will also fill the gap in the literature as there are currently no prospective trials on this topic.

Eligibility

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

External beam radiotherapy is a common treatment for prostate cancer, but it can sometimes cause scarring in the urethra (the tube you urinate through), known as a urethral stricture. This condition can make urination difficult and may require further procedures to treat. Despite this being a known risk, there is currently very little research tracking how often it happens. This study aims to measure how frequently urethral strictures develop in men undergoing radiotherapy for prostate cancer. Participants simply attend follow-up assessments every six months for five years, which include answering some questions and doing a non-invasive urine flow test (urinating into a flow meter) that takes about 10 minutes. You may be eligible if you are a man over 18 having external beam radiotherapy for prostate cancer at Icon Cancer Centre in Toowoomba. Men who have previously had pelvic radiotherapy for another cancer or who have had urethral strictures in the past are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Uroflow measurements at baseline, 6 weeks post end of radiation therapy treatment and then every 6 months for 5 years post radiation treatment for prostate cancer. AUA surveys completed at baseline,

Uroflow measurements at baseline, 6 weeks post end of radiation therapy treatment and then every 6 months for 5 years post radiation treatment for prostate cancer. AUA surveys completed at baseline, 6 weeks post end of radiation therapy treatment and then every 6 months for 5 years post radiation treatment. Radiation oncologists or a member of the study team will perform uroflow measurements at each follow up appointment and input data into database. Each uroflow measurement takes approximately 5-10 minutes to complete. This follow up will be performed at the radiation oncology centre in Toowoomba via face-to-face appointments.