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
| ISRCTN | ISRCTN15835424 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15835424 |
| Secondary identifying numbers | ARCTU-SUH-001 |
- Submission date
- 09/04/2015
- Registration date
- 10/04/2015
- Last edited
- 11/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Contact information
Dr Michael Harrison
Scientific
Scientific
Anglia Ruskin University
Post Graduate Medical Institute Clinical Trials Unit
Bishops Hall Lane
Chelmsford
CM1 1SQ
United Kingdom
Study information
| Study design | Randomised controlled two-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | 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 |
| Study acronym | THEPCA |
| Study hypothesis | Prospective assessment of genitourinary toxicities according to the treatment sequence of HDR brachytherapy and EBRT. |
| Ethics approval(s) | NRES Ethics, 22/09/2014, ref: 14/LO/1662 |
| Condition | Prostate cancer |
| Intervention | 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 Brachytherapy before EBRT In Arm B (control): Patients receive EBRT before HDR Brachytherapy. The assessment of the acute and late toxicities at various time points will be carried out. The treatment should start within 3 months from the randomisation date. |
| Intervention type | Mixed |
| Primary outcome measure | Prospective assessment of genitourinary toxicities according to the treatment sequence of HDR Brachytherapy and EBRT. |
| Secondary outcome measures | 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 |
| Overall study start date | 22/01/2015 |
| Overall study end date | 01/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 50 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 25/01/2015 |
| Recruitment end date | 01/01/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southend University Hospital NHS Foundation Trust
Prittlewell Chase
Westcliff on Sea
SS0 0RY
United Kingdom
Westcliff on Sea
SS0 0RY
United Kingdom
Sponsor information
Southend University Hospital NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Prittlewell Chase, Westcliff-on-Sea, Essex SS0 0RY
Southend
SS0 0RY
England
United Kingdom
| Website | http://www.southend.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/05fa42p74 |
Funders
Funder type
Not defined
Southend University Hospital NHS Foundation Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/04/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/11/2018: No publications found, verifying study status with principal investigator.
