Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98241100
Enrollment
Unknown
Registered
2004-01-23
Start date
1997-07-07
Completion date
Unknown
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Prostate

Interventions

Standard external beam radiotherapy 55 Gy (control) versus external beam 34 Gy plus brachytherapy 17 Gy

Sponsors

NHS R&D Regional Programme Register - Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Not provided at time of registration

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026