prostate cancer
Conditions
Interventions
Experimental group:systemic treatment + prostate cryotherapy
control group:systemic treatment
Sponsors
Renji Hospital, Shanghai Jiaotong University of Medicine
Eligibility
Sex/Gender
Male
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) diagnosed as prostate cancer by histology; (2) ECT, whole body MRI or PET-CT (choline/PSMA) indicated bone metastasis lesions; (3) fully understand the primary tumor reduction treatment and sign the informed consent form; (4) Expected survival time > 5 years (WHO Performance Status 0-1); (5) Aged 40-75 years old; (6) Systemic treatment (ADT or ADT combined with docetaxel chemotherapy) for less than 6 months, no other treatment (surgery, radiotherapy, etc.); (7) The tumor responded well to the treatment of continuous ADT (PSA minimum value <0.1ng/ml; 2 or more new lesions did not appear in the imaging evaluation of bone metastases); (8) prostate volum was less than 50ml; (9) without Opioid analgesics usage history (including codeine and dextropropoxyphene); (10) without azole drugs usage history (such as fluconazole, itraconazole, etc.); (11) The important laboratory indicators are as follows: hemoglobin = 90g/L; neutrophils =1.5 * 10^9/L; platelet count = 100 * 10^9/L; blood potassium = 3.5mmol/L; liver function indicators: ALT, AST = 1.5 times the upper limit of normal (ULN), TBIL = 1.5ULN (except for documented Gilbert syndrome); serum albumin = 30g/L.
Exclusion criteria
Exclusion criteria: (1) special pathological types other than adenocarcinoma, including neuroendocrine tumors, prostate sarcoma, etc; (2) imaging confirmed visceral metastasis; (3) receiving systemic system for more than 6 months, or disease progresses within half a year, or the volume of prostate is still greater than 50 ml after treatment; (4) other diseases or conditions that cannot tolerate clinical trials, including but not limited to: cardiac insufficiency (NYHA III or IV) ), severe infection (NCI-CTCAE = 2), Crohn's disease or ulcerative colitis, coagulopathy, skeletal malformation can not be combined with surgery, lower extremity deep vein thrombosis, mental disorders impairing social function, etc; (5) Other diseases or conditions that affect the accuracy of results, including but not limited to: immunosuppression (HIV infection, taking hormones, etc.), combined with autoimmune diseases, history of allergies within 4 weeks prior to randomization, and other malignant History of cancer, combined with urinary incontinence; (6) There are contraindications for long-term use of hormonal therapy or docetaxel chemotherapy, including: uncontrolled diabetes, hypertension, hyperlipidemia; uncontroled coronary heart disease, atherosclerosis, stroke (7) Other circumstances which is inappropriate to participate in the study. (8) swallowing difficulty; (9) with history of chemotherapy for other tumors, contraindications for chemotherapy or endocrine therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease specific survival;overall survival;quality of live; | — |
Countries
China
Contacts
Public ContactFan Xu
Renji Hospital, Shanghai Jiaotong University of Medicine
Outcome results
None listed