Metastatic Prostate Carcinoma
Conditions
Brief summary
The goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT) treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The primary objective: to determine disease biochemical progression-free survival in man with oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive radiotherapy of the primary tumor. The secondary objective: to determine local control, overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing carbon ion radiotherapy
Interventions
RADIATIONCIRT with systemic therapy arm
carbon ion radiotherapy to the prostate(59.2GyE/16Fx to prostate and seminal vesicle) Systemic therapy:Hormonal therapy (LHRH agonist and/or antiandrogens) or chemotherapy
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
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically confirmed adenocarcinoma of the prostate 2. Age ≥ 20 and \< 80 years of age 3. ECOG PS 0 or 1 4. Life-expectancy ≥1 year 5. Stage T1-4,N0-1,M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions. 6. Ability to understand and willingness to sign informed consent
Exclusion criteria
1. No pathologically confirmed adenocarcinoma of the prostate 2. visceral metastasis 3. Previous pelvic radiotherapy or prostatectomy 4. Severe systemic disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to PSA relapse | From the start of systemic therapy, a median of 2 years |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival | From the start of systemic therapy, a median of 2 years |
| Overall survival | From the start of systemic therapy, a median of 2 years |
| Quality of life | From the start of carbon ion radiotherapy, a median of 2 years |
Countries
China
Contacts
Primary ContactPing Li, MD.
Backup ContactQing Zhang, MD.
Outcome results
None listed