NCT07495293Not yet recruitingPhase 1
Ultra-hypofractionated Carbon-ion Therapy for Prostate Cancer
Carbon-ion Therapy With Ultra-hypofractionated RadiothErapy for Localized Prostate Cancer (CURE-PC-1): Phase I Clinical Trial
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Yonsei University
- Diseases
- Prostate cancer
- NCT number
- NCT07495293
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 1 Jun 2026 to the primary completion date, 31 Dec 2029
- No sites listed in no 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 history of pelvic radiotherapy or prostate surgery
- 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 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
Other illness
- 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 psychiatric disorders or cognitive impairment considered unable to comply with the treatment plan
- Patients with a history of surgical treatment for benign prostatic hyperplasia, such as transurethral resection of the prostate (TURP) or holmium laser enucleation of the prostate (HoLEP)
Other
- Patients who underwent multiparametric prostate MRI after biopsy
Who the study is looking for
- 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:
- Low risk: PSA ≤10 ng/mL AND Gleason score 6 (Grade Group 1) AND cT1-T2a
- Intermediate risk: PSA 10-20 ng/mL OR Gleason score 7 (Grade Group 2-3) OR cT2b-T2c, without any high-risk features
- 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
- Multiparametric prostate MRI performed prior to biopsy
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.