Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial (NCT07130682) | Clinical Trial Compass
RecruitingNot Applicable
Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial
Hong Kong35 participantsStarted 2025-09-01
Plain-language summary
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 participate
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinician-reported grade 2 or above genitourinary and gastrointestinal toxicity
Timeframe: 3 months and 24 months after treatment completion with a minimum of 24 months of follow-up and an average of 5 years.