SABRE 1: Surgery Against Brachytherapy - a Randomised Evaluatio

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN88144169
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23826842

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-16
• Study Completion: 2013-06-01
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Decision aid randomisation:<br> Proportion of patients consenting to the treatment randomisation<br><br> Treatment randomisation:<br> Feasibility of randomisation in terms of average accrual rate per centre during the last 6 months of recruitment.<br>