Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorHong Kong Sanatorium & Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pencil Beam Proton Therapy Treatment Machine
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov