NCT05106699

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Shanghai Proton and Heavy Ion Center · Academic / Other
• Sex: Male
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	proton plus carbon ion radiation	All patients received whole pelvis and prostate region proton irradiation of 46 GyE in 23 fractionsfollowed by localized carbon ion irradiation of 32GyE in 8 fractions to the prostate region. The dose to metastatic LN was escalated using simultaneous integrated boost (SIB) technique. The dose was 60-62.1GyE in 23 fractions as much as dose constraints. All patients will be recommened receive 2-3 years endocrine therapy.

Timeline

• Start date: 2021-06-08
• Primary completion: 2025-05-31
• Completion: 2026-05-31
• First posted: 2021-11-04
• Last updated: 2021-11-04

Locations

1 site across 1 country: China