beta
Trial Radar AI
Clinical Trial NCT07495293 for Prostate Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Ultra-hypofractionated Carbon-ion Therapy for Prostate Cancer Phase 1 20 Long-Term Follow-up

Not yet recruiting
Clinical Trial NCT07495293 is designed to study Treatment for Prostate Cancer. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 24 March 2026 until the study accrues 20 participants. Led by Yonsei University, this study is expected to complete by 8 March 2031. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary
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 ...Show More
Detailed Description
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...Show More
Official Title

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

Conditions
Prostate Cancer
Other Study IDs
  • 4-2026-0055
NCT ID Number
NCT07495293
Start Date (Actual)
2026-03-24
Last Update Posted
2026-03-27
Completion Date (Estimated)
2031-03-08
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
19 Years
Eligible Sexes
All

  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 logoYonsei University200 active studies to explore
Study Central Contact
Contact: Chan Woo Wee, Assistant Professor, +82-2-2228-8121, [email protected]
No location data.