Condition category
Cancer
Date applied
09/04/2015
Date assigned
10/04/2015
Last edited
07/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Michael Harrison

ORCID ID

Contact details

Anglia Ruskin University
Post Graduate Medical Institute Clinical Trials Unit
Bishops Hall Lane
Chelmsford
CM1 1SQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ARCTU-SUH-001

Study information

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.

Acronym

THEPCA

Study hypothesis

Prospective assessment of genitourinary toxicities according to the treatment sequence of HDR brachytherapy and EBRT.

Ethics approval

NRES Ethics, 22/09/2014, ref: 14/LO/1662

Study design

Randomised controlled two arm trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Other

Phase

Drug names

Primary outcome measures

Prospective assessment of genitourinary toxicities according to the treatment sequence of HDR Brachytherapy and EBRT.

Secondary outcome measures

1. To assess 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 trial start date

22/01/2015

Overall trial end date

01/01/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

50

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

United Kingdom

Trial participating centre

Southend University Hospital NHS Foundation Trust
Prittlewell Chase Westcliff on Sea SS0 0RY UK
SS0 0RY
United Kingdom

Sponsor information

Organisation

Southend University Hospital NHS Foundation Trust

Sponsor details

Prittlewell Chase
Westcliff-on-Sea
Essex SS0 0RY
Southend
SS0 0RY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.southend.nhs.uk/

Funders

Funder type

Not defined

Funder name

Southend University Hospital NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25926023

Publication citations

Additional files

Editorial Notes