RecruitingNot ApplicableNCT07130682

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


Sponsor

Hong Kong Sanatorium & Hospital

Enrollment

35 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study is testing a shorter prostate cancer radiation treatment using proton therapy delivered in just two sessions, guided by MRI scans, in men with low- or intermediate-risk prostate cancer. **You may be eligible if...** - You are under 18 years old — NOTE: the inclusion criteria states "Men aged < 18 years" which appears to be a data entry error; please confirm with the study team - You have been diagnosed with low- or intermediate-risk prostate cancer confirmed by biopsy - Your overall health is good (ECOG score less than 2) - You are able to undergo MRI scans **You may NOT be eligible if...** - You have a history of inflammatory bowel disease or another cancer - You have had prior pelvic radiation, chemotherapy, prostatectomy, cryosurgery, or focused ultrasound for prostate cancer - You have a history of bladder neck or urethral stricture - You have had a previous TURP (a procedure to unblock urine flow) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPencil Beam Proton Therapy Treatment Machine

2 fractions will be delivered to treat low- or intermediate- risk prostate cancer


Locations(1)

Hong Kong Sanatorium and Hospital

Hong Kong, Hong Kong

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NCT07130682


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