None listed
Conditions
Interventions
Radiation : This is a single-arm study in which all enrolled participants will receive carbon ion radiotherapy (CIRT) according to the following procedures.
1. Carbon Ion Radiotherapy : CIRT will be
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male patients aged 19 years or older who are able to provide written informed consent 2. Histologically confirmed prostatic adenocarcinoma within 6 months prior to the first treatment (either carbon ion radiotherapy or androgen deprivation therapy, whichever comes first) 3. Documented pre-biopsy serum prostate-specific antigen (PSA) level available 4. 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 5. No evidence of distant metastasis or regional lymph node metastasis 6. Adequate general condition for prostate cancer treatment as determined by ECOG Performance Status 0 or 1 7. Multiparametric prostate MRI performed prior to biopsy
Exclusion criteria
Exclusion criteria: 1. Prior history of pelvic radiotherapy or prostate surgery 2. 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 3. 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 4.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.) 5.Patients with psychiatric disorders or cognitive impairment considered unable to comply with the treatment plan 6.Patients currently participating in another investigational drug or medical device study concurrently with this study 7.Patients for whom carbon ion radiotherapy is physically difficult due to artificial hip prostheses or other metallic implants 8.Patients who underwent multiparametric prostate MRI after biopsy 9.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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute treatment-related toxicity of Grade 3 or higher per CTCAE v5.0 occurring within 90 days after completion of carbon ion radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative incidence of late treatment-related toxicity per CTCAE v5.0 occurring beyond 90 days after completion of carbon ion radiotherapy up to 2 years;Biochemical relapse-free survival (bRFS) at 2 and 5 years, defined by the Phoenix criteria (PSA nadir + 2.0 ng/mL);Patient-reported quality of life assessed using EPIC-26 and IPSS questionnaires | — |
Countries
Korea, Republic of
Contacts
Public ContactDonghee Ha
Yonsei University Health System, Severance Hospital
Outcome results
None listed