Clinical trial · Interventional
Timing of HDR With EBRT in Localised Prostate Cancer,Toxicity and Quality of Life Assessment
A Randomised 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
TITLE Timing of HDR brachytherapy with EBRT in intermediate and high risk localised Prostate CAncer patients and its effects on Toxicity and Quality of life - randomised feasibility trial. SHORT TITLE THEPCA trial Protocol Version Number and Date Version 2.1, dated 16 DEC 2014 Study Duration Recruitment Duration 18-24 months Study Centre Southend University Hospital NHS Foundation Trust Objectives Assessment of acute toxicities: Genitourinary, gastrointestinal and sexual dysfunction at various time points. Number of Participants 50 participants Main Inclusion Criteria * Patient age \>18 years * Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0 * Any Gleason score * Any PSA level * Patient able to consent and fill in the questionnaires Exclusion Criteria - Previous TURP/HoLEP Laser Prostatectomy * Any Metastatic Disease * IPSS\>20 * Pubic arch interference * Lithotomy position or anaesthesia not possible * Rectal fistula * Prior pelvic radiotherapy Statistical Methodology and Analysis Percentages of adverse events will be compared using Fisher's Exact Test. Toxicity score means will be compared using two-sample permutation t-tests, and PSA relapse-free survival will be estimated using Kaplan-Meier and compared using log-rank tests.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External beam Radiotherapy | Radiation | — | UNRESOLVED |
| HDR Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- HDR Brachytherapy single dose of 15 Gy followed by EBRT of 46 Gy in 23 fractions and Androgen deprivation therapy 6 months to 3 years, (sequencing of HDR followed by EBRT)
- interventionNames
- Radiation: HDR Brachytherapy
- Radiation: External beam Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- ARM B
- description
- External Beam Radiotherapy (EBRT) of 46 Gy in 23 fractions, followed by single dose of HDR brachytherapy of 15 Gy boost and Androgen deprivation therapy 6 months to 3 years (timing of HDR Brachytherapy Treatment is changed compared to ARM A)
- interventionNames
- Radiation: HDR Brachytherapy
- Radiation: External beam Radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient age \>18 years * Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0 * Any Gleason score * Any PSA level * Patient able to consent and fill in the questionnaires Exclusion Criteria: * Previous TURP/HoLEP Laser Prostatectomy * Any Metastatic Disease * IPSS\>20 * Pubic arch interference * Lithotomy position * If Anaesthesia is not possible * Rectal fistula * Prior pelvic radiotherapy
References
Publications (0)
Data not yet available