Clinical trial · Interventional
Carbon Ion Followed by Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases
Carbon Ion Boost Followed by Pelvic Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases: Prospective Phase II Study
- 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 present of clinically pelvic lymph node positive (cN1) represent one of the most important prognostic factors for recurrence and cancer-specific mortality of prostate cancer patients. Approximately 12% of prostate cancer patients present with cN1 disease at the time of diagnosis. Furthermore, with the advent of more sensitive advance diagnostic imaging techniques, such as PSMA PET/CT, the likelihood that pelvic nodes will be found earlier and more frequently. Unfortunately, The optimal treatment for patients with cN1 still remains unclear. Androgen deprivation therapy (ADT) is the cornerstone of prostate cancer with pelvic lymph node metastasis. Some retrospective and database studies have shown that addition of local radiotherapy (RT) to ADT improve the treatment outcome. The 2022 NCCN guideline recommend RT combined with 2 to 3 years ADT in patients with initially diagnosed cN1 prostate cancer who have a life expectancy greater than 5 years.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| proton plus carbon ion radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carbon ion followed by Proton radiotherapy
- description
- All patients received whole pelvis and prostate region radiotherapy. The dose to metastatic LN was escalated using simultaneous integrated boost (SIB) technique.
- interventionNames
- Radiation: proton plus carbon ion radiation
Primary outcomes (1)
- measure
- Biochemical relapse free survival
- timeFrame
- From the start of systemic therapy, a median of 3 years
- description
- The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)
Secondary outcomes (5)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven initial diagnosis of adenocarcinoma of the prostate; * Clinical stage T1-4 N0 M0; * Prostatic assessment by multiparametric (mp) MRI; * Pelvic lymph node was assessed by PSMA PET/CT and mpMRI; * No distant metastasis was proven by PSMA PET/CT; * Patients may received neoadjuvant hormonal therapy; * 45≤ Age ≤85; * Adequate performance status (ECOG 0-1); * 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; * Written informed consent; Exclusion Criteria: * No pathologically confirmed adenocarcinoma of the prostate; * Distant metastasis (M1); * Previous pelvic radiotherapy; * Previous prostatectomy;
References
Publications (0)
Data not yet available