Clinical trial NCT05106699: Carbon Ion Followed by Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases
Official title: Carbon Ion Boost Followed by Pelvic Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases: Prospective Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Carbon ion
Proton
prostate cancer
pelvic lymph nodes metastases
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 54
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Biochemical relapse free survival
timeFrame: From the start of systemic therapy, a median of 3 years
Secondary outcomes:
measure: Progression free survival
timeFrame: From the start of systemic therapy, a median of 3 years
measure: Overall survival
timeFrame: From the start of systemic therapy, a median of 3 years
measure: Metastasis free survival
timeFrame: From the start of systemic therapy, a median of 3 years
measure: Acute toxicities
timeFrame: Within 3 months of the start of particle therapy
measure: Late toxicities
timeFrame: 3 months after the completion of particle therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center
name: Qing Zhang, M.D.
role: STUDY_DIRECTOR
References: