Cryoablation Therapy or Radiotherapy Therapy for Stage III Prostate Cancer
NCT ID: NCT02605226
Last Updated: 2017-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2015-11-30
2018-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I
Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
Patients receive cryoablation therapy.
Cryoablation therapy
Cryoablation therapy
bicalutamide
bicalutamide
luteinizing-hormone releasing-hormone (LHRH) agonist
luteinizing-hormone releasing-hormone (LHRH) agonist
Arm II
Patients receive androgen ablation as in arm I. Patients receive external beam radiation therapy.
External beam radiation therapy
External beam radiation therapy
bicalutamide
bicalutamide
luteinizing-hormone releasing-hormone (LHRH) agonist
luteinizing-hormone releasing-hormone (LHRH) agonist
Interventions
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Cryoablation therapy
Cryoablation therapy
External beam radiation therapy
External beam radiation therapy
bicalutamide
bicalutamide
luteinizing-hormone releasing-hormone (LHRH) agonist
luteinizing-hormone releasing-hormone (LHRH) agonist
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
MALE
No
Sponsors
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The Third Xiangya Hospital of Central South University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Peking University First Hospital
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Shandong Cancer Hospital and Institute
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Tianjin First Central Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhi Guo, PhD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Institue and Hospital
Locations
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Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TMU-CIH-IR-004
Identifier Type: -
Identifier Source: org_study_id
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