None listed
Conditions
Brief summary
To test whether image guided radiotherapy for prostate carcinoma has less treatment related side effects and impairment of quality of life when an endorectal balloon is inserted during the radiotherapy compared to image guided radiotherapy alone.
Interventions
Investigational arm: insertion of endorectal balloon during image guided radiotherapy. An endorectal balloon is inserted into the rectum prior to the radiation treatment to the prostate each day and inflated with 100mls of air and removed at the end of treatment each day.
Sponsors
Professor Eric Yeoh
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Localised prostate cancer T1a - T3b, N0, M0 Any gleason score PSA equal to or less than 30 micrograms/L ECOG 0-2 Signed informed consent
Exclusion criteria
-Metastatic cancer of the prostate or disease involving organs such as the bladder and rectum - T4, N0,M0 -ECOG equal to or greater than 3. -Constant requirement for medication likely to interfere with evaluation of anorectal motility such as anti-diarrhoeal or opiate analgesic drugs. -Haemorrhoids greater than or equal to grade II (as evaluated using Common Terminology Criteria for Adverse Events V3.0 -Colitis equal to or greater than Grade II (as evaluated using Common Terminology Criteria for Adverse Events V3.0 -Any other anorectal disease that the clinician feels would interfere with the tolerance of the ERB during IGRT such as fissures, fistulas or abscesses. -Previous radiation therapy to the pelvis. - No signed informed consent
Outcome results
None listed