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

NCT04081428 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Prostate Cancer
  • Radiotherapy Side Effects
  • Volatile Organic Compounds
  • DNA Damage

Interventions

RADIATION

Stereotactic Body Radiotherapy

Daily collection of breath and blood before and after each of the 5 radiotherapy treatment sessions. Before and after daily cone beam CT image collection

Sponsors & Collaborators

  • NHS Lothian

    lead OTHER_GOV

Principal Investigators

  • Duncan B McLaren, MBBS · NHS Lothian

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04081428 on ClinicalTrials.gov