Clinical Trial

Using Breath, Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT

Study acronym: PRINToUT
Active, Not Recruiting
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Record status
This record was last updated February 13, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-09-04; most recent amendment 2026-02-11.
Status change: Recruiting → Active, Not Recruiting 2025-02-11
Trial Details
NCT Number NCT04081428
Lead Sponsor NHS Lothian
Conditions Prostate Cancer, Radiotherapy Side Effects, Volatile Organic Compounds, DNA Damage
Enrollment 60 participants
Start Date 2018-10-11
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-13