Prostate Cancer
Conditions
Keywords
Carbon ion, Proton, prostate cancer, pelvic lymph nodes metastases
Brief 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.
Interventions
RADIATIONproton 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.
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 85 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical relapse free survival | From the start of systemic therapy, a median of 3 years | The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | From the start of systemic therapy, a median of 3 years | The time from start of systemic therapy to tumor progression or death |
| Overall survival | From the start of systemic therapy, a median of 3 years | The time from diagnosis to death from any cause |
| Metastasis free survival | From the start of systemic therapy, a median of 3 years | The time from start of systemic therapy to tumor metastatsis. |
| Acute toxicities | Within 3 months of the start of particle therapy | Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 |
| Late toxicities | 3 months after the completion of particle therapy | Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale |
Countries
China
Contacts
Primary ContactPing Li, M.D.
Outcome results
None listed