Selecting Hypoxic Tumours for Treatment Modification

Approximately 50% of cancer patients with solid tumours will be treated with radiotherapy. A significant proportion (\>25%) of patients have hypoxic tumours which respond poorly to radiotherapy. Hypoxic tumours have a poor prognosis. This can be improved with treatment intensification. Treatment intensification can be modification with CON (breathing O2-enriched air + oral administration of nicotinamide), chemoradiosensitisation, radiation dose-escalation or additional systemic treatments, significantly improving response of the tumours to radiotherapy. However, there are currently no clinically approved biomarkers to identify hypoxic tumours. Our group has developed and validated gene-expression signature-based biomarkers that identify patients with hypoxic bladder, head and neck , prostate, sarcoma and lung cancers. The bladder cancer gene-expression hypoxia signature has been shown to predict benefit from hypoxia modification using RNA from archived tumour tissue. The main purpose of this study is to demonstrate in at least two cancer types that the hypoxia biomarker predicts benefit from hypoxia modification in real-time.

NCT Number	NCT06787053
Lead Sponsor	University of Manchester
Conditions	Bladder (Urothelial, Transitional Cell) Cancer, Prostate Cancer
Enrollment	30 participants
Start Date	2024-10-16
Primary Completion	2028-05-30 (estimated)
Study Completion	2028-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-12