Two-session MRI-guided proton treatment for low- and intermediate-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial delivers two high-precision, MRI-guided stereotactic body proton therapy (SBPT) fractions with real-time on-board tumor tracking to men with low- or intermediate-risk prostate cancer. The goal is to match the safety and cancer-control outcomes of the standard five-fraction SBPT while reducing the number of treatment visits. Investigators will collect clinician- and patient-reported outcomes, including EPIC questionnaires, and monitor acute and late toxicity. Key exclusions include prior pelvic radiotherapy or prostate surgery, large prostate volume, hip replacements, MRI contraindications, and metastatic disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Hong Kong Sanatorium and Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Oi Lei Wong, Ph.D.
• Email: oilei.ol.wong@hksh.com
• Phone: 1-852-2917 5550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.