Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial
Recruiting · NCT07130682 · Interventional (participants receive a specific treatment) · Lead sponsor: Hong Kong Sanatorium & Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Pencil Beam Proton Therapy Treatment Machine
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Hong Kong Sanatorium and Hospital - Hong Kong, Hong Kong