NCT07495293Toborzás még nem indult1. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 22.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2026. márc. 16.
- Kezdés
- 2026. jún. 1.
- Elsődleges befejezés
- 2029. dec. 31.
- Fő szponzor
- Yonsei University
- Betegségek
- Prosztatarák
- NCT-szám
- NCT07495293
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 20
- 2026. jún. 1. és az elsődleges befejezés (2029. dec. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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
Más betegség
- 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)
Egyéb
- Patients who underwent multiparametric prostate MRI after biopsy
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 19 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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