NCT07130682Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 28 Jul 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 2 Jan 2033
- Lead sponsor
- Hong Kong Sanatorium & Hospital
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07130682
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 1 Sept 2025 to the primary completion date, 2 Jan 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy, chemotherapy, radical prostatectomy, cryosurgery, or focal therapy (e.g. high-intensity focused ultrasound \[HIFU\]) for prostate cancer
- Transurethral resection of the prostate (TURP) \< 8 weeks prior to SBPT
- Previous androgen deprivation therapy (ADT) lasting more than 6 months
Other illness
- History of inflammatory bowel disease or other cancers (except prostate cancer)
- History of bladder neck or urethral stricture
Other
- 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
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hong Kong Sanatorium and Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.