Clinical trial · Interventional
Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer
NCT02739659CI-TRIAL-00055129unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carbon-ion radiotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- carbon-ion radiotherapy
- description
- Five dose levels \[59.2 GyE(Gray equivalent)/16Fx, 60.8 GyE/16Fx, 62.4 GyE/16Fx, 64.0 GyE/16Fx and 65.6 GyE/16Fx\] are planned within the Phase I part. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 65.6 GyE/16Fx are safely delivered, the recommended dose (or 65.6 GyE/16Fx) will be the prescribed dose in the Phase II part of the study.
- interventionNames
- Device: carbon-ion radiotherapy
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- From the date of CIRT to 6 months after the completion of CIRT, up to 6 months
Secondary outcomes (3)
- measure
- Overall survival of all patients
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed adenocarcinoma of the prostate * No lymph node and distant metastasis * Age ≥ 20 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)except for skin non-melanoma cancer * 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) * Urinary obstructive symptoms (IPSS \> 20) * Previous pelvic radiotherapy * Previous prostatectomy * Severe systemic disorders * Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin) * Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer * Non conformity of the radiotherapy dose distribution when compared to the dose constraints * Psychiatric disorders or any other condition that can make unreliable the informed consent
References
Publications (1)
- DERIVEDZhang Y, Li P, Yu Q, Wu S, Chen X, Zhang Q, Fu S. Preliminary exploration of clinical factors affecting acute toxicity and quality of life after carbon ion therapy for prostate cancer. Radiat Oncol. 2019 Jun 4;14(1):94. doi: 10.1186/s13014-019-1303-3. PMID 31164172