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El ensayo clínico NCT07495293 para Cáncer de próstata está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Ultra-hypofractionated Carbon-ion Therapy for Prostate Cancer Fase I 20 Seguimiento a largo plazo

Aún no recluta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07495293 está diseñado para estudiar el tratamiento de Cáncer de próstata. Este es un estudio intervencionista de Fase I. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 24 de marzo de 2026 hasta completar 20 participantes. Dirigido por la Universidad Yonsei, se espera que finalice el 8 de marzo de 2031. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
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 ...Mostrar más
Descripción detallada
STUDY DESIGN This study is a prospective, single-arm clinical study designed to evaluate the safety of an ultra-hypofractionated carbon ion radiotherapy (CIRT) regimen in patients with localized prostate cancer. A total of 20 participants will be enrolled sequentially at a single institution. An initial cohort of 10 participants will be enrolled first. If fewer than 2 participants develop Grade ≥3 treatment-related a...Mostrar más
Título oficial

Carbon-ion Therapy With Ultra-hypofractionated RadiothErapy for Localized Prostate Cancer (CURE-PC-1): Phase I Clinical Trial

Condiciones médicas
Cáncer de próstata
Otros ID del estudio
  • 4-2026-0055
Número del NCT
NCT07495293
Inicio del estudio (real)
2026-03-24
Última actualización
2026-03-27
Fecha de finalización (estimada)
2031-03-08
Inscripción (prevista)
20
Tipo de estudio
Intervencionista
FASE
Fase I
Estado general
Aún no recluta
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
N/A
ultra-hypofractionated carbon ion therapy
Participants 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)
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
90 days after completion of carbon ion therapy
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
2 years after completion of carbon ion radiotherapy
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)
2 years and 5 years from the date of treatment initiation
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.
Before CIRT, and at 12 weeks, 24 weeks, 1 year, and 2 years after completion of carbon ion radiotherapy
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.
Before CIRT, and at 12 weeks, 24 weeks, 1 year, and 2 years after completion of carbon ion radiotherapy.
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
19 Years
Criterios de sexo
Todos

  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 2.2025:

    • 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 treatment initiation

  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 psychiatric disorders or cognitive impairment that would preclude compliance with the treatment plan
  5. Patients currently enrolled in another investigational drug or medical device study concurrent with this trial
  6. Patients for whom carbon ion radiotherapy is physically not feasible due to artificial hip joints or other metallic implants.
Yonsei University logoUniversidad Yonsei200 estudios activos para explorar
Contactos centrales del estudio
Contacto: Chan Woo Wee, Assistant Professor, +82-2-2228-8121, [email protected]
Sitio no especificado.