A Trial Assessing Post-Operative Use of ProSpare, a Rectal Obturator in Prostate Cancer Radiotherapy

Inclusion criteria:

1. Patient has undergone radical prostatectomy
2. Histologically confirmed prostatic cancer
3. Patient due to receive post-operative prostate bed radiotherapy either in the adjuvant or salvage\* setting
4. WHO performance status 0-1 at randomization
5. Age \> 18 years
6. Written informed consent
7. Able to independently complete patient questionnaires

Exclusion Criteria:

1. Lymph node or distant metastases from prostate cancer
2. Prior pelvic radiotherapy
3. Previous invasive cancer in the past 3 years, with the exception of non-melanoma skin cancer
4. Symptomatic haemorrhoids or other anal conditions which affect adequate insertion and retention of the rectal obturator
5. Planned chemotherapy within 2 months of completion of adjuvant or salvage radiotherapy
6. Musculoskeletal conditions which limit flexibility or mobility and will make patient self insertion of ProSpare™ difficult
7. Comorbid conditions likely to impact on advisability of prostate bed radiotherapy (e.g. inflammatory bowel disease, previous colorectal surgery, significant bladder instability or urinary incontinence)