Carbon ion therapy with imaging guidance for prostate cancer
Official title: Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial
Run by Shanghai Proton and Heavy Ion Center · NCT05010343 · Data updated 2026-11-12
This study is testing if a new type of radiation therapy using carbon ions can effectively treat localized prostate cancer while keeping side effects low.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 45 Years to 85 Years |
| Sex | Men only |
| Enrollment | 140 (estimated) |
| Sponsor | Shanghai Proton and Heavy Ion Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | October 15, 2020 |
| Main results expected | July 1, 2025 |
| Study ends | July 1, 2028 |
| Registry record updated | November 15, 2021 |
| Trial ID | NCT05010343 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 45 to 85 with localized prostate cancer who have not undergone previous pelvic radiation or prostatectomy.
✕Probably not a fit
Patients with metastatic prostate cancer or those who have had prior pelvic radiation therapy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II clinical trial evaluates the effectiveness and safety of carbon ion irradiation combined with simultaneous integrated boost for localized prostate cancer. The approach utilizes advanced imaging techniques, including PSMA PET/CT and multi-parameter MRI, to precisely target the primary tumor site. By focusing treatment on the tumor while minimizing exposure to surrounding healthy tissue, the study aims to improve biochemical disease-free survival without increasing toxicity. Participants will be monitored for treatment-related side effects and clinical outcomes.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and reduce side effects for patients with localized prostate cancer.
How similar studies have gone: Other studies using carbon ion therapy have shown promising results, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed adenocarcinoma of prostate * Stage cT1-3N0M0 localized prostate cancer * performed PSMA PET/CT and mpMRI before treatment * No lymph nodes or distant metastasis * Age ≥ 45 and \< 85 years of age * Karnofsky Performance Score ≥70 * No previous pelvic radiation therapy (RT) * No previous prostatectomy * No previous invasive cancer (within 5 years before the prostate cancer diagnosis) * Ability to understand character and individual consequences of the clinical trial * Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial Exclusion Criteria: * No pathologically confirmed adenocarcinoma of the prostate * Pelvic lymph node metastasis (N1) * Distant metastasis (M1) * Previous pelvic radiotherapy * Previous prostatectomy
Where it's running
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Shanghai Proton and Heavy Ion Center
Shanghai, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.