Stage IV Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREcryoablation
Cryoablation therapy
DRUGBicalutamide
bicalutamide
luteinizing-hormone releasing-hormone (LHRH) agonist
Sponsors
Peking University First Hospital
Tianjin First Central Hospital
Shandong Cancer Hospital and Institute
Shanghai Jiao Tong University School of Medicine
The Third Xiangya Hospital of Central South University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median biochemical progression-free survival | Within 12 months after treatment | It measures the time to biochemical progression (PSA progression). |
| Quality of Life impact of treatments' side effects measured by change in EORTC QOL-C30 from baseline to 3, 6 and 12 months after treatment | 3, 6 and 12 months after treatment | European Organization for Research and Treatment of Cancer(EORTC) |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 5 year |
| Disease Specific Survival | 5 year |
Countries
China
Contacts
Primary ContactZhi Guo, PhD
Backup ContactXueling Yang
Outcome results
None listed