NCT04081428Active, not recruiting
Using Breath, Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT
Using Breath,Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT With RayPilot® Motion Management
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
Personalisation of radiotherapy dose based on real-time assessments of normal tissue and tumour response would maximise cure and minimise treatment related toxicity. During a 5 fraction course of prostate Stereotactic Body Radiotherapy (SBRT) this pilot study will assess whether a number of different biomarker approaches can predict for normal tissue and tumour response. Firstly the investigators will analyse volatile organic compounds released within the breath with each fraction of treatment. Secondly the investigators will analyse cell free normal tissue and tumour DNA released during treatment. Thirdly the investigators will develop imaging processing algorithms to look for imaging biomarkers predicting rectal wall toxicity using pre and post treatment cone beam CT verification images. Each of these approaches will be assessed against prostate specific antigen (PSA), Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria and Expanded Prostate Cancer Index Composite (EPIC-26) patient reported outcomes with a maximum of 24 months of follow up.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 1 Aug 2019
- Start date
- 11 Oct 2018
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- NHS Lothian
- Diseases
- Prostate cancer
- NCT number
- NCT04081428
What you commit to
- Study type: Observational
- Planned participants: 60
- From 11 Oct 2018 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous androgen deprivation therapy
Other illness
- Inflammatory bowel disease
- History of urinary retention
Who the study is looking for
- Low risk prostate cancer T1-2, PSA\<10ng/ml, Gleason score (GS) 3+3=6
- Intermediate risk prostate cancer T1-T2, PSA 10-20ng/ml,GS ≤7(3+4=7 only)
- World Health Organisation (WHO) performance status 0-2
- Prostate volume ≤90cc
- International Prostate Symptom Score (IPSS) ≤20
- Peak urinary flow rate (Q-max) \>10cc/sec
- Urinary residual \<250mls total
- No prior Trans Urethral Resection of the Prostate (TURP)
- No previous pelvic radiotherapy
- Able to give informed consent
- Aged between 18-85 years of age
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Edinburgh Cancer Centre, Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.