Clinical trial · Interventional
12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer
Phase I Study on Carbon Ion Radiotherapy in 12 Fractions for Localized Prostate Cancer
NCT04724577CI-TRIAL-00055118unknownN/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 arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center.
Conditions
Conditions (2)
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carbon ion radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carbon ion treatment
- description
- dose escalation study with five dose levels \[54GGyE(Gray equivalent)/12Fx,55.2GyE/12Fx,56.4GyE/12Fx,57.6GyE/12Fx and 58.8GyE/12Fx \].
- interventionNames
- Radiation: carbon ion radiotherapy
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- 3 months after the completion of CIRT
- description
- Treatment related acute toxicity assessed by CTCAE v4.03
Secondary outcomes (3)
- measure
- Biochemical failure free survival,bFFS
- timeFrame
- From the complation of CIRT,a median of 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed adenocarcinoma of prostate * Stage cT1-3N0M0 localized prostate cancer * 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
References
Publications (0)
Data not yet available
No reference posted for this study.