Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT06284304
Brief Summary:
Trial design: A single centre phase II non-randomised study
Trial population: Men with intermediate risk localised prostate cancer
Recruitment target: 20 patients in total
Trial objectives:
* Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects
* Secondary
* To assess levels of acute GU and GI toxicity (CTCAE)
* To assess levels of late GU and GI toxicity (CTCAE)
* To assess late sexual quality of life (expanded EPIC, IIEF-5)
* To assess biochemical relapse-free survival at 2 years
Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
Detailed Description:
Primary endpoint: Technical feasibility of treating prostate cancer with toxicity- minimising radiotherapy on an MR-linac
Secondary endpoint:
* Physician reported GU and gastrointestinal (GI) toxicity (CTCAE grade) at baseline and the end of treatment then at 4 weeks and 3 months post-treatment.
* Late toxicity (CTCAE v5.0) at 1 and 2 years post-treatment
* Patient-reported outcome measures (PROMs) from the EPIC-26, IPSS, and IIEF-5 questionnaires. Patients will be asked to complete PROMs at 4 weeks, 3 and 6 months, 1 and 2 years post treatment.
* PSA control and kinetics at 2 years post-treatment
Quality of life: EPIC-26 QoL will be measured at baseline, then at 4 weeks and 3, 6, 12 and 24 months from end of treatment. IIEF-5 will be completed at baseline and months 6, 12 and 24. IPSS will be measured at all time points.
Follow-up: Patients will be assessed at 6, 12 and 24 months and then as per standard of care.
Study:
NCT06284304
Study Brief:
Protocol Section:
NCT06284304