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

RecruitingNAAges any - anyMaleHong Kong Sanatorium & Hospital
NCT07130682 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Men aged \< 18 years with histologically confirmed low- or intermediate-risk prostate cancer per NCCN guidelines * Eastern Cooperative Oncology Group (ECOG) performance status \<2 * Ability to undergo magnetic resonance imaging (MRI) simulation scans without absolute contraindications, such as cardiac implantable electronic devices * Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire Exclusion Criteria: * History of inflammatory bowel disease or other cancers (except prostate cancer) * Prior pelvic radiotherapy, chemotherapy, radical prostatectomy, cryosurgery, or focal therapy (e.g. high-intensity focused ultrasound \[HIFU\]) for prostate cancer * History of bladder neck or urethral stricture * Transurethral resection of the prostate (TURP) \< 8 weeks prior to SBPT * Prostate volume \> 100cc on MRI * Unilateral or bilateral hip replacements * Nodal or distant metastases, as indicated by computed tomography (CT), MRI, or prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans * Previous androgen deprivation therapy (ADT) lasting more than 6 months
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What it tests

  • Pencil Beam Proton Therapy Treatment Machine
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Where

1 site
Hong Kong Sanatorium and Hospital
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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