Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer

A Prospective Multi-center Study to Compare the QOL and Efficacy of Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer.

This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with endocrine therapy with or without cryoablation.

OBJECTIVES:

• To determine the tumor control in patients with prostate cancer treated with radiotherapy or cryoablation
• To determine the quality of life of these patients. OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), persistent prostatic specific antigen (PSA) at allocation (> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center. Patient are allocated to two treatment arms.

Inclusion Criteria:

• Prostate adenocarcinoma, T4N0M0, Any T with N+ or M+
• Previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer
• Survival ≥ 12 months
• WHO performance status 0-2
• white blood cell ≥ 3.5 ×10*9/L
• Platelets ≥ 5×10*9/L
• Hemoglobin ≥ 10 g/dL

Exclusion Criteria:

• History of malignant disease
• History of coronary artery disease
• Uncontrolled infection
• Other concurrent severe or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration)
• Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule