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Prostate CancerPhase 1NCT07495293

Ultra-hypofractionated Carbon-ion Therapy for Prostate Cancer

A Phase 1 study testing ultra-hypofractionated carbon ion therapy in people with Prostate Cancer, run by Yonsei University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Prostate Cancer
What is being tested?
ultra-hypofractionated carbon ion therapy
Type of treatment
Surgery or procedure
How many people
20 participants
Where
No sites listed yet
Study dates
1 Jun 2026to 8 Mar 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.)
  • Patients with psychiatric disorders or cognitive impairment considered unable to comply with the treatment plan
  • Patients currently participating in another investigational drug or medical device study concurrently with this study
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  • Patients for whom carbon ion radiotherapy is physically difficult due to artificial hip prostheses or other metallic implants
  • Patients who underwent multiparametric prostate MRI after biopsy
  • 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)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Chan Woo Wee, Assistant Professor contact

+82-2-2228-8121

wcw0108@yuhs.ac

About this study

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

Read the 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 acute toxicity within 90 days of completing CIRT, an additional 10 participants will be enrolled to reach the total sample size of 20. Participants will receive CIRT according to the following procedures.

  1. Carbon Ion Radiotherapy : CIRT will be administered at 7 GyE per fraction, twice weekly on alternating days, for a total of 6 fractions over 3 weeks (total prescribed dose: 42 GyE). At the investigator's discretion, a simultaneous integrated boost (SIB) of 6 GyE × 6 fractions (total 36 GyE) may be prescribed to the seminal vesicle target. Treatment planning will be performed using RayStation with consideration of dose constraints for the rectum and bladder.
  2. Androgen Deprivation Therapy (ADT) : ADT will not be administered to low-risk and favorable intermediate-risk patients. Unfavorable intermediate-risk patients will receive ADT concurrently for a total of 6 months, with the first dose completed prior to CIRT initiation. Permitted agents include GnRH agonists (Leuprolide, Goserelin, Triptorelin), GnRH antagonists (Degarelix, Relugolix), and anti-androgens (Bicalutamide, Flutamide, Nilutamide).
  3. Permitted Procedures : Insertion of gold fiducial markers for image-guided radiotherapy and SpaceOAR hydrogel for rectal protection are permitted as part of the institutional standard of care and are not considered part of the study intervention.
Conditions
Prostate Cancer
Being tested
ultra-hypofractionated carbon ion therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultra-hypofractionated carbon ion therapyRadiation

    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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 90 days after completion of carbon ion therapy

Secondary outcomes (4)

  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

    Measured: 2 years after completion of carbon ion radiotherapy

  2. 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)

    Measured: 2 years and 5 years from the date of treatment initiation

  3. 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.

    Measured: Before CIRT, and at 12 weeks, 24 weeks, 1 year, and 2 years after completion of carbon ion radiotherapy

  4. 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.

    Measured: Before CIRT, and at 12 weeks, 24 weeks, 1 year, and 2 years after completion of carbon ion radiotherapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion8 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07495293
Sponsor's protocol ID
4-2026-0055
Status last verified
May 2026
First submitted
16 Mar 2026
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ultra-hypofractionated carbon ion therapy in people with Prostate Cancer, run by Yonsei University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chan Woo Wee, Assistant Professor (+82-2-2228-8121, wcw0108@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

acute treatment-related toxicity (time frame: 90 days after completion of carbon ion therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07495293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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