Stage III Prostate Cancer Clinical Trial
— CRYO-PCA-IIIOfficial title:
A Prospective Multi-center Study to Compare the QOL and Efficacy of External Beam Radiation Therapy or Cryoablation Therapy for Stage III Prostate Cancer
This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with radiotherapy or cryoablation.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Prostate adenocarcinoma, T3aN0M0, T3bN0M0 - 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 |
Country | Name | City | State |
---|---|---|---|
China | Tianjin Medical University Cancer Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University Cancer Institute and Hospital | Peking University First Hospital, Shandong Cancer Hospital and Institute, 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, The Third Xiangya Hospital of Central South University, Tianjin First Central Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median PSA progression-free survival in patients responding to the study treatments | Within 12 months after treatment | ||
Primary | 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 | European Organization for Research and Treatment of Cancer(EORTC) | 3, 6 and 12 months after treatment | |
Secondary | Overall survival | 5 year | ||
Secondary | Disease Specific Survival | 5 year |
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