Ultra-hypofractionated Carbon-ion Therapy for Prostate Cancer
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Low risk: PSA ≤10 ng/mL AND Gleason score 6 (Grade Group 1) AND cT1-T2a
Disqualifiers
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.)
Trial design
Design model
Single group
Treatments tested in this trial
ultra-hypofractionated carbon ion therapy
RadiationParticipants will receive carbon ion radiotherapy with a total prescribed dose of 42 GyE, delivered as 7 GyE per fraction over six fractions, administered twice weekly (every other day)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
acute treatment-related toxicity
Incidence of acute treatment-related toxicity of grade 3 or higher per Common Terminology Criteria for Adverse EventsCTCAE) v5.0 occurring within 90 days after completion of carbon ion therapy
Time frame
90 days after completion of carbon ion therapySecondary outcomes
1
late treatment-related toxicity
Cumulative incidence of late treatment-related toxicity per Common Terminology Criteria for Adverse Events(CTCAE)v5.0 occurring beyond 90 days after completion of carbon ion radiotherapy up to 2 years
Time frame
2 years after completion of carbon ion radiotherapy2
Biochemical relapse-free surviva
Biochemical relapse-free survival (bRFS) at 2 and 5 years, defined by the Phoenix criteria (PSA nadir + 2.0 ng/mL)
Time frame
2 years and 5 years from the date of treatment initiation3
Patient-reported quality of life
Patient-reported quality of life assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26). Scores range from 0 to 60, with higher scores indicating worse quality of life.
Time frame
Before CIRT, and at 12 weeks, 24 weeks, 1 year, and 2 years after completion of carbon ion radiotherapy4
Patient-reported quality of life
Urinary symptom burden assessed using the International Prostate Symptom Score (IPSS). Scores range from 0 to 35, with higher scores indicating worse urinary symptoms.
Time frame
Before CIRT, and at 12 weeks, 24 weeks, 1 year, and 2 years after completion of carbon ion radiotherapy.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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