Randomised trial of interstitial brachytherapy as a component of radical radiotherapy for localised prostatic carcinoma

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer; Prostate

• Registration Number: ISRCTN98241100
• Lead Sponsor: HS R&D Regional Programme Register - Department of Health (UK)

Brief Summary

2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22341794 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31059955 results (added 08/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-01-23
• Study Completion: 2004-07-07
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 218

Inclusion Criteria

Patients with prostatic carcinoma who after routine staging have no evidence of distant metastasis. Patients will be male and over 40 years of age. In general external beam treatment is delivered as an outpatient whilst the interstitial treatment will require two to three days inpatient care.

Exclusion Criteria

1. Prostate specific antigen (PSA) over 50
2. Previous Transurethral Resection of the Prostate (TURP)
3. Radiological evidence of distant metastasis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. An improvement in local control for prostatic carcinoma as defined by:<br> a. PSA response<br> b. Changes on digital rectal examination<br> c. Local symptom-free duration<br> d. Quality of Life (FACT-P)<br> 2. Prolonged disease specific survival consequent upon the improved local survival<br> 3. Reduced bowel morbidity because of the more localised nature of the interstitial component of the radiation dose delivered<br>

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration