Status:
ACTIVE_NOT_RECRUITING
Using Breath, Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT
Lead Sponsor:
NHS Lothian
Conditions:
Prostate Cancer
Radiotherapy Side Effects
Eligibility:
MALE
18-80 years
Brief 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 pros...
Detailed Description
Radiotherapy scheduling and prescription dose does not take into account individual patient heterogeneity in normal tissue response or tumour response. Personalisation of radiotherapy dose based on re...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Inflammatory bowel disease
- Previous androgen deprivation therapy
- History of urinary retention
Key Trial Info
Start Date :
October 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 11 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04081428
Start Date
October 11 2018
End Date
January 11 2026
Last Update
February 12 2025
Active Locations (1)
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1
Edinburgh Cancer Centre, Western General Hospital
Edinburgh, Mid Lothian, United Kingdom, EH4 2XU