NCT07130682

Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial

2-fraction Stereotactic Body Proton Therapy (SBPT) With Magnetic Resonance Imaging (MRI) Guidance in Localized Prostate Cancer: A Single-arm Phase II Non-randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Hong Kong Sanatorium & Hospital · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is testing a shorter treatment method for prostate cancer using proton therapy (PT), which is very precise and may cause fewer side effects compared to traditional radiation. However, it is expensive and not easily accessible for many patients. To make it more affordable and accessible, this study is testing whether 2 fractions of stereotactic body proton therapy (SBPT) can be as safe and effective as the standard 5 sessions.

Detailed description

Proton therapy is an advanced form of radiation that precisely targets tumors while minimizing damage to healthy tissues. However, its high cost has limited patient access. For prostate cancer, studies have already shown that ultra-short radiation courses (as few as 2-5 sessions) using conventional X-ray-based stereotactic body radiation therapy (SBRT) provide excellent results with manageable side effects. This study aims to investigate whether 2-fraction stereotactic body proton therapy (SBPT) with magnetic resonance imaging (MRI) guidance and real-time on-board tumor tracking can achieve similar safety and efficiency as the standard 5-fraction SBPT, with the added benefit of lower costs and greater convenience for patients.

Conditions

• Prostate Cancer Patients Treated by Radiotherapy

Interventions

Type	Name	Description
RADIATION	Pencil Beam Proton Therapy Treatment Machine	2 fractions will be delivered to treat low- or intermediate- risk prostate cancer

Timeline

• Start date: 2025-09-01
• Primary completion: 2033-01-02
• Completion: 2033-06-02
• First posted: 2025-08-19
• Last updated: 2026-03-16

Locations

1 site across 1 country: Hong Kong