Clinical trial · Interventional
Carbon Ions Boost Followed by Pelvic Photon Radiotherapy for High Risk Prostate Cancer
NCT02672449CI-TRIAL-00067644unknownN/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 test the feasibility and safety of a new treatment schedule for high risk prostate cancer that allows the administration of high doses to the prostate tumor with a mixed beam approach of carbon ions boost followed by pelvic IMRT.
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 |
|---|---|---|---|
| Adenocarcinoma of Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon Ions Boost Followed by Pelvic Photon Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- External beam radiotherapy
- description
- A total of 65 consecutive newly diagnosed prostate cancer patients with 2013 NCCN high risk category will be consecutively enrolled in a prospective phase II trial on Carbon Ions Boost Followed by Pelvic Photon Radiotherapy .
- interventionNames
- Radiation: Carbon Ions Boost Followed by Pelvic Photon Radiotherapy
Primary outcomes (1)
- measure
- Number of patients with Grade 3 or Grade 4 adverse events that are related to radiotherapy treatment according to the validated scale Radiotherapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG / EORTC).
- timeFrame
- one month after radiotherapy
- description
- Toxicity and quality of life data will be prospectively assessed and analysed descriptively. Toxicities will be graded according to the Common Toxicity Criteria for adverse events (CTCAE) toxicity criteria v4.0 and Radiotherapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) criteria. Inacceptable toxicity will be \> 3 patients with acute side effects grade 4, or \> 3 patients with late RTOG/EORTC, CTCAE side effects grade 4, or \> 3 patients with late RTOG/EORTC, CTCAE side effects grade 3, or any grade 5 toxicity.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate, high-risk category according to NCCN version 2013 (T3a and/or PSA \> 20 ng/ml and/or Gleason score of 8-10) * cN0 and cM0 * Good performance status (ECOG\<2) * No previous pelvic RT * No previous prostatectomy * No concomitant bowel inflammatory disease or other serious comorbidities * Good urinary flow (peak flow \> 10 ml/s) * No previous invasive cancer (within 5 years before the PCa diagnosis) apart from non-melanoma skin malignancies. Exclusion criteria * Pelvic lymph node metastasis (N1) * Distant metastasis (M1) * Urinary obstructive symptoms (IPSS \> 20) * Previous pelvic radiotherapy * 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 in situ cervix cancer or 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 can make unreliable the informed consent
References
Publications (2)
- DERIVEDMarvaso G, Jereczek-Fossa BA, Riva G, Bassi C, Fodor C, Ciardo D, Cambria R, Pansini F, Zerini D, De Marco P, Cattani F, De Cobelli O, Orecchia R. High-Risk Prostate Cancer and Radiotherapy: The Past and the Future. A Benchmark for a New Mixed Beam Radiotherapy Approach. Clin Genitourin Cancer. 2017 Jun;15(3):376-383. doi: 10.1016/j.clgc.2017.01.007. Epub 2017 Jan 18. PMID 28190704
- DERIVEDJereczek-Fossa BA, Fanetti G, Fodor C, Ciardo D, Santoro L, Francia CM, Muto M, Surgo A, Zerini D, Marvaso G, Timon G, Romanelli P, Rondi E, Comi S, Cattani F, Golino F, Mazza S, Matei DV, Ferro M, Musi G, Nole F, de Cobelli O, Ost P, Orecchia R. Salvage Stereotactic Body Radiotherapy for Isolated Lymph Node Recurrent Prostate Cancer: Single Institution Series of 94 Consecutive Patients and 124 Lymph Nodes. Clin Genitourin Cancer. 2017 Aug;15(4):e623-e632. doi: 10.1016/j.clgc.2017.01.004. Epub 2017 Jan 11. PMID 28185875