Prostate Caner
Conditions
Interventions
experimental group:radical prostatectomy+ PSMA-SPECT/CT guided radiotherapy to metastatic sites + 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 metastatic disease by imaging confined to lymph nodes or bone. The number of metastatic sites was less or equal to 3. 5. ECOG: 0 or 1. 6. Allowed previous treatment: androgen deprivation therapy started within 6 months before enrollment. 7. Estimated life expectancy >2 years. 8. No history of radiotherapy to pelvis, oligo-metastatic sites and nearby structure. 9. The primary lesion of prostate could be treated with surgery and radiotherapy without severe complications including death, severe urinary incontinence, injury of rectum and life-threatening hemorrhage. 10. Willing and able to provide informed consent. 11. 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. 3. Organ-metastasis including liver, lung, brain and so on. 4. Small cell carcinoma of prostate. 5. Poor heath condition that could not tolerant treatment to primary lesion or metastatic lesion. 6. Unacceptable of the complications brought by treatment to primary lesion or metastatic lesion. 7. History of another cancer (except for basal cell carcinoma or other cancers cured for over 5 years ). 8. 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. 9. Enrolled in another trial before. 10. Contraindicated for radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;PSA progression-free survival;quality of life;predictive ability of tumor biomarkers;Efficacy of different imaging examination in evaluating metastatic lesion; | — |
Countries
China
Contacts
Public ContactDingwei Ye
Outcome results
None listed