Ultra-hypofractionated Carbon-ion Therapy for Prostate Cancer (NCT07495293) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Ultra-hypofractionated Carbon-ion Therapy for Prostate Cancer
20 participantsStarted 2026-06-01
Plain-language summary
This is a single-arm, exploratory phase I clinical trial evaluating the safety and efficacy of ultra-hypofractionated carbon ion radiotherapy (CIRT) in 6 fractions compared to the conventional 12-fraction regimen in patients with low- and intermediate-risk localized prostate cancer. A total of 20 patients will be enrolled sequentially and treated with CIRT at 7 GyE per fraction, delivered twice weekly on alternating days, for a total of 6 fractions (total prescribed dose: 42 GyE). Androgen deprivation therapy for 6 months will be administered concurrently in patients classified as unfavorable intermediate-risk. The primary endpoint is the incidence of acute treatment-related toxicity of Grade 3 or higher per CTCAE v5.0 occurring within 90 days after completion of CIRT. Secondary endpoints include the incidence of late toxicity, biochemical relapse-free survival (bRFS), and quality of life assessed by EPIC-26 and IPSS questionnaires. Patients will undergo scheduled follow-up visits for 2 years after treatment completion, followed by long-term follow-up through electronic medical record review up to 5 years.
Who can participate
Age range
19 Years
Sex
ALL
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
. Male patients aged 19 years or older who are able to provide written informed consent
. Histologically confirmed prostatic adenocarcinoma within 6 months prior to the first treatment (either carbon ion radiotherapy or androgen deprivation therapy, whichever comes first)
. Documented pre-biopsy serum prostate-specific antigen (PSA) level available
. Classified as one of the following risk groups based on NCCN Guidelines Version 5.2026:
. No evidence of distant metastasis or regional lymph node metastasis
. Adequate general condition for prostate cancer treatment as determined by ECOG Performance Status 0 or 1
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
acute treatment-related toxicity
Timeframe: 90 days after completion of carbon ion therapy
. Multiparametric prostate MRI performed prior to biopsy
Exclusion criteria
. Prior history of pelvic radiotherapy or prostate surgery
. History of malignancy other than prostate cancer, except for the following: cervical carcinoma in situ, completely resected non-melanoma skin cancer, or any cancer with disease-free status maintained for 5 or more years after treatment
. Patients deemed inappropriate for carbon ion radiotherapy due to active infection, bleeding disorders, or severe cardiac, hepatic, or renal dysfunction, or patients who have undergone major surgery or experienced a major cardiovascular event (e.g., myocardial infarction, cerebral infarction, or cerebral hemorrhage) within the past 6 months
. Patients with evidence of prostatitis or urinary tract infection on screening urinalysis and urine culture (However, enrollment is permitted if the condition improves on follow-up evaluation prior to carbon ion radiotherapy.)
. Patients with psychiatric disorders or cognitive impairment considered unable to comply with the treatment plan
. Patients currently participating in another investigational drug or medical device study concurrently with this study
. Patients for whom carbon ion radiotherapy is physically difficult due to artificial hip prostheses or other metallic implants
. Patients who underwent multiparametric prostate MRI after biopsy