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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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.
Shanghai Proton and Heavy Ion Center
Shanghai, China
RECRUITINGBiochemical relapse free survival
The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)
Time frame: From the start of systemic therapy, a median of 3 years
Progression free survival
The time from start of systemic therapy to tumor progression or death
Time frame: From the start of systemic therapy, a median of 3 years
Overall survival
The time from diagnosis to death from any cause
Time frame: From the start of systemic therapy, a median of 3 years
Metastasis free survival
The time from start of systemic therapy to tumor metastatsis.
Time frame: From the start of systemic therapy, a median of 3 years
Acute toxicities
Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time frame: Within 3 months of the start of particle therapy
Late toxicities
Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale
Time frame: 3 months after the completion of particle therapy
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