Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
This trial includes two stages of randomisation.
Randomisation 1: Participants are initially randomised to either receive standard patient information or to receive the standard patie
Sponsors
Southampton University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Suspected prostate cancer that is confined to the prostate 2. Due for prostate biopsy 3. World Health Organisation performance status 0 - 1 4. Prostate-Specific Antigen (PSA) less than 15 ng/ml 5. Life expectancy more than 10 years 6. Written informed consent Inclusion criteria for treatment randomisation: 1. Participation in decision aid randomisation 2. Histologically confirmed prostate cancer 3. Clinical T stage T1/T2 4. Either Gleason score less than or equal to 6 with a PSA of less than 15 or Gleason score 3 + 4 in less than 50% of the cores with a PSA less than 10 (PSA test less than 3 months prior to treatment intervention)
Exclusion criteria
Exclusion criteria: 1. Unacceptable risk for radical prostatectomy 2. Unacceptable risk for brachytherapy 3. Prior pelvic radiotherapy 4. Other active malignancy likely to interfere with subsequent protocol treatment and follow-up 5. Previous abdominoperineal (AP) rectal excision 6. Previous transurethral resection of their prostate gland (TURP) 7. Significant obstructive urinary symptoms (peak urine flow rate less than 10 ml per second, post micturition bladder volume greater than 75 ml) 8. Severe lower urinary tract symptoms 9. Inability to attend or comply with treatment or follow-up scheduling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decision aid randomisation: Proportion of patients consenting to the treatment randomisation Treatment randomisation: Feasibility of randomisation in terms of average accrual rate per centre during the last 6 months of recruitment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Decision aid randomisation: Decisional quality post-treatment Treatment randomisation: 1. Compliance with allocated treatment 2. Clinical failure. Duration of follow-up: 10 years 3. PSA relapse. Duration of follow-up: 10 years 4. Patient-reported quality of life at 5 years (see below for details) 5. Toxicity. Duration of follow-up: 10 years Quality of life will be measured using a 50-question document to include the following: a. The 12-item short form health survey (SF-12; General quality of life) b. European Quality of Life questionnaires (EQ-5D; General quality of life to tie in with health economic data) c. The International Continence Society 'male short-form' (ICSmaleSF) questionnaire (urinary functioning) d. Vaizey Questionnaire (A short, validated bowel function questionnaire) e. The International Index of Erectile Function (IIEF5) The questionnaires will be amalgamated into one single 50-question document which will be administered as a single questionnaire at each assessment point. Quality of Life questionnaire compliance will be carefully monitored during this feasibility trial; this and clinical outcomes will be used as one basis for the sample size calculation for the SABRE 2 phase III trial. | — |
Countries
Canada, United Kingdom
Outcome results
None listed