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Completed

NCT Number: NCT03832803

Less to Hold - A Comparison of Bladder Toxicities (Side Effects) in Patients Undergoing Prostate Radiotherapy Between Patients Treated With Empty Bladder and Those on a Drinking Protocol.

Radical radiotherapy to the prostate is conventionally treated with a full bladder with the aim of minimising dose to the bladder and small bowel to prevent significant side effects. Tolerance of the bladder filling protocol varies depending on patients' baseline urinary function. It is not uncommon for some men to have "accidents" during treatment causing understandable distress. This can also extend the treatment time and cause knock on delays in the radiotherapy department.

Several United Kingdom (UK) centres report treating with an empty bladder. The investigators carried out a feasibility study comparing treatment with full bladder to empty bladder to ascertain if the investigators can safely change our protocol to that of an empty bladder.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Radiation Injuries Radiotherapy Side Effect Urogenital Diseases Urogenital Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

About this study

50 patients receiving radical radiotherapy to the prostate were randomised using closed envelope technique 1:1 into 2 groups. Group A followed the conventional drinking protocol at our centre (200ml prior to treatment) and group B were treated with an empty bladder. Baseline, end of treatment and 6 week follow up scores were prospectively collected for International prostate Symptom Score(IPSS), Late Effects Normal Tissue Task Force - Subjective, Objective, Management, Analytic (LENT SOMA) bowel toxicity and quality of life questionnaires. The investigators also looked at bowel and bladder Dose Volume Histogram (DVH) to ensure constraints were met.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prostate cancer receiving radical radiotherapy.

Exclusion criteria

  • Not nodal disease.
  • Not prostate bed radiotherapy.

Treatment and study plan

Empty bladder

Behavioral

No drinking protocol.

Full bladder

Behavioral

Followed drinking protocol

Primary outcomes

  1. Change in IPSS score

    Time frame: Baseline to end of treatment (4 weeks or 7 and a half weeks depending on radiotherapy schedule); to 6 week follow up; and to 1 year follow up.

    IPSS - The International Prostate Symptom Score is a 7 question scale which assesses urinary toxicity. Each question is scored 0-5 totalling a maximum score of 35. A score of 0-7 correlates to mildly symptomatic; 8-19, moderately symptomatic; 20-35, severely symptomatic.

Secondary outcomes

  1. Change in LENT SOMA score

    Time frame: Baseline to end of treatment (4 weeks or 7 and a half weeks depending on radiotherapy schedule); to 6 week follow up; and to 1 year follow up.

    LENT SOMA - The Late Effects in Normal Tissues Subjective, Objective, Management and Analytic Scales. This is a questionnaire that assesses individual bowel symptoms asking initially whether or not they occur and then scoring the frequency, the higher the score, the more frequent the event. Each question has it's own range of score which is explained on the questionnaire. The scores will be compared for individual questions and there will not be any combining of scores between questions.

  2. Bowel and bladder DVH

    Time frame: At time of radiotherapy planning scan which happens at baseline, on day of randomisation.

    Dose to bowel and bladder is calculated and documented if it meets the optimal or mandatory constraints

Sponsors and collaborators

Lead sponsor

Lancashire Teaching Hospitals NHS Foundation Trust

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 6, 2019
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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