Prostate Cancer
Conditions
Interventions
experimental group:radical prostatectomy + proton and heavy ion radiotherapy + androgen deprivation therapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male; 2. Aged 18 to 80 years; 3. Histologically or cytologically confirmed adenocarcinoma of prostate; 4. Confirmed asymptomatic metastatic disease by imaging. Total number of metastatic sites was less or equal to 5. The number of metastatic sites within an organ or a system was less or equal to 3; 5. ECOG: 0 or 1; 6. Estimated life expectancy >2 years; 7. No history of treatment to prostate and oligo-metastatic sites; 8. The primary lesion of prostate could be treated with surgery without severe complications including death, severe urinary incontinence, injury of rectum and life-threatening hemorrhage; 9. Willing and able to provide informed consent; 10. Treatment and follow-up could be arranged.
Exclusion criteria
Exclusion criteria: 1. Previous treatment to primary lesion of prostate and metastatic lesions including radical prostatectomy, radical radiotherapy and radiotherapy of metastatic sites; 2. History of chemotherapy or hormonal therapy; 3. Small cell carcinoma of prostate; 4. Poor heath condition that could not tolerant treatment to primary lesion or metastatic lesion; 5. Unacceptable of the complications brought by treatment to primary lesion or metastatic lesion; 6. History of another cancer (except for basal cell carcinoma or other cancers cured for over 5 years); 7. Other severe disease, such as unstable heart disease, myocardial infarction within 6 months before enrollment, NYHA 3-4, uncontrolled hypertension after treatment, severe neural or mental disorder, uncontrolled active infection, acute gastric ulcer, hypercalcemia and COPD requiring hospitalization; 8. Enrolled in another trial before; 9. Contraindicated for radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;PSA response;quality of life;lesion control rate; | — |
Countries
China
Contacts
Public ContactDingwei Ye
Fudan University Shanghai Cancer Center
Outcome results
None listed