A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL — DESTINATION  

Prostate Cancer Clinical Trial

Official title: A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT06284304
• Study type: Interventional
• Source: The Netherlands Cancer Institute
• Contact: Floris Pos, MD PhD
• Phone: +31 20 512 9111
• Email: f.pos@nki.nl
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Completion date: April 1, 2027