A randomised study of image guided radiotherapy for prostate carcinoma with and without endorectal balloon.

Phase 4

Recruiting

• Conditions: prostate carcinoma; Cancer - Prostate

• Registration Number: ACTRN12611000749909
• Lead Sponsor: Professor Eric Yeoh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 140

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Image guided radiotherapy treatment with endorectal balloon results in less treatment related morbidity and impairment of quality of life compared with image guided radiotherapy alone.[Less treatment related morbidity and impairment of QOL- Lent Soma and QLQC30 and QLQ-PR25: Baseline, End of Treatment, 6 week, 3 month, 6 month, 9 month, 1 year, 18 month, 2 year, 30 month and 3 year.];Using the endorectal balloon results in better radiation dose distributions to the rectal and anal walls.[Dose volume histograms: End of treatment]

Secondary Outcome Measures

Name	Time	Method
Quantify and compare radiation-induced changes in anorectal function using anorectal manometry to compare parameters of anorectal function and radiation dose distribution in the rectal and anal walls with and without the use of the endorectal balloon.[Anorectal Manometry: baseline, 6 weeks, 1 year, 2 year and 3 year];Monitor treatment efficacy based on clinical, radiological and serum PSA evaluation at pre-determined intervals after completion of therapy.[Serum PSA: Baseline, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, 3 years.]