Prostate cancer
Conditions
Interventions
ADT+RP:ADT and radical prostatectomy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male patients; 2. Aged 18 to 80 years; 3. Histologically or cytologically proven prostate carcinoma; 4. Documented evidence of M1 disease by AJCC (American Joint Committee on Cancer) staging by Bone scan, CT and/or MRI; and metastatic lesions are limited to the lymph nodes or bones, at the same time the number of lesions should less than or equal to 5; 5. ECOG PS 0 or 1; 6. Treatment initiation with androgen deprivation therapy no longer than 6 months prior to randomization; 7. Life-expectancy based on comorbid conditions >2 years; 8. No serious medical complications; 9. The primary lesion of prostate cancer has not yet received local treatment; 10. Must be a candidate for surgery and/or radiation therapy and follow-up and the treatment will not bring about serious complications to patients; 11. Ability to understand and willingness to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Had received treatment for primary lesion, including: radical prostatectomy, radical radiation therapy and so on; 2. Patients who received systemic chemotherapy before; 3. Androgen deprivation therapy time is greater than six months; 4. Visceral organ metastasis (liver, lung, brain and other organs); 5. Small cell carcinoma of the prostate; 6. Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely; 7. Patients who are not willing to accept the complications caused by the treatment to primary lesion; 8. Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years); 9. Other serious diseases, for example: unstable heart disease after treatment, myocardial infarction in 6 months prior to treatment, cardiac function grade 3-4 (NYHA); high blood pressure that can not be controlled after medical treatment (greater than 150/90mmHg); serious neurological or mental disorders, including dementia and epilepsy; uncontrolled active infection; acute gastric ulcer; hypocalcemia; chronic obstructive pulmonary disease that needs hospital treatment; 10. Has participated in other clinical research before.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Time to PSA Progression; | — |
Countries
China
Contacts
Public ContactHua Xu
Fudan University Shanghai Cancer Center
Outcome results
None listed