Investigating the timing of high dose rate (HDR) brachytherapy with external beam radiation therapy (EBRT) in intermediate and high risk localised prostate cancer patients and its effects on toxicity and quality of life

A randomised controlled feasibility trial to investigate the timing of HDR Brachytherapy with EBRT in intermediate and high risk localised prostate cancer patients and its effects on toxicity and quality of life

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15835424

Enrollment

Registered

2015-04-10

Start date

2015-01-25

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

Prostate cancer Cancer

Interventions

This will be a randomised two arm trial in which intermediate and high risk prostate cancer patients treated with both HDR brachytherapy and EBRT. In Arm A: Patients receive HDR Brachy

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Patient age >18 years 2. Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0 3. Any Gleason score 4. Any PSA level 5. Patient able to consent and fill in the questionnaires

Exclusion criteria

Exclusion criteria: 1. Previous TURP/HoLEP Laser Prostatectomy 2. Any Metastatic Disease 3. IPSS>20 4. Pubic arch interference 5. Lithotomy position 6. If Anaesthesia is not possible 7. Rectal fistula 8. Prior pelvic radiotherapy

Design outcomes

Primary

Measure	Time frame
Prospective assessment of genitourinary toxicities according to the treatment sequence of HDR Brachytherapy and EBRT.	—

Secondary

Measure	Time frame
1. Treatment outcomes including biochemical response and survival 2. Prospective assessment of gastrointestinal toxicities according to the treatment sequence of HDR brachytherapy and EBRT 3. Assessment of Radiotherapy Planning Challenges including Image Guided Radiotherapy	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026