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Trial Radar IA
Lo studio clinico NCT07495293 per CANCRO ALLA PROSTATA è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Ultra-hypofractionated Carbon-ion Therapy for Prostate Cancer Fase I 20 Follow-up lungo termine

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07495293 è uno studio interventistico di Fase I volto a esaminare il trattamento per CANCRO ALLA PROSTATA, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 24 marzo 2026, con l'obiettivo di raggiungere 20 partecipanti. Sotto la guida di l'Università Yonsei, dovrebbe concludersi entro il 8 marzo 2031. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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 ...Mostra di più
Descrizione dettagliata
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...Mostra di più
Titolo ufficiale

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

Patologie
CANCRO ALLA PROSTATA
Altri ID dello studio
  • 4-2026-0055
Numero NCT
NCT07495293
Data di inizio (effettiva)
2026-03-24
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2031-03-08
Arruolamento (previsto)
20
Tipo di studio
Interventistico
FASE
Fase I
Stato
Non ancora in arruolamento
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
N.D.
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)
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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.
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
19 Years
Sessi idonei
Tutti

  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 logoUniversità Yonsei200 studi clinici attivi da esplorare
Contatti principali dello studio
Contatto: Chan Woo Wee, Assistant Professor, +82-2-2228-8121, [email protected]
Nessun dato sulle località