Actively Recruiting
Carbon Ion Followed by Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases
Led by Shanghai Proton and Heavy Ion Center · Updated on 2021-11-04
54
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Carbon Ion Followed by Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven initial diagnosis of adenocarcinoma of the prostate
- Clinical stage T1-4 N0 M0
- Prostatic assessment by multiparametric (mp) MRI
- Pelvic lymph node assessment by PSMA PET/CT and mpMRI
- No distant metastasis proven by PSMA PET/CT
- May have received neoadjuvant hormonal therapy
- Age between 45 and 85 years
- Adequate performance status (ECOG 0-1)
- No previous pelvic radiation therapy
- No previous prostatectomy
- No previous invasive cancer within 5 years before prostate cancer diagnosis
- Ability to understand the study and its consequences
- Written informed consent
You will not qualify if you...
- No pathologically confirmed adenocarcinoma of the prostate
- Presence of distant metastasis (M1)
- Previous pelvic radiotherapy
- Previous prostatectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Proton and Heavy Ion Center
Shanghai, China
Actively Recruiting
Research Team
P
Ping Li, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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