Back to resultsEndocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer (CRYO-PCA-IV)
Primary Purpose
Stage IV Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cryoablation
Bicalutamide
luteinizing-hormone releasing-hormone (LHRH) agonist
Sponsored by
About this trial
This is an interventional treatment trial for Stage IV Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Tianjin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm1
Arm2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Median biochemical progression-free survival
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
European Organization for Research and Treatment of Cancer(EORTC)
Secondary Outcome Measures
Overall survival
Disease Specific Survival
Full Information
NCT ID
NCT02615223
First Posted
November 17, 2015
Last Updated
June 9, 2017
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT02615223
Brief Title
Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer
Acronym
CRYO-PCA-IV
Official Title
A Prospective Multi-center Study to Compare the QOL and Efficacy of Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
cryoablation
Intervention Description
Cryoablation therapy
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Intervention Description
bicalutamide
Intervention Type
Drug
Intervention Name(s)
luteinizing-hormone releasing-hormone (LHRH) agonist
Intervention Description
luteinizing-hormone releasing-hormone (LHRH) agonist
Primary Outcome Measure Information:
Title
Median biochemical progression-free survival
Description
It measures the time to biochemical progression (PSA progression).
Time Frame
Within 12 months after treatment
Title
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
Description
European Organization for Research and Treatment of Cancer(EORTC)
Time Frame
3, 6 and 12 months after treatment
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 year
Title
Disease Specific Survival
Time Frame
5 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Guo, PhD
Phone
02223340123
Ext
1095
Email
cjr.guozhi@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xueling Yang
Phone
02223340123
Ext
1095
Email
yxueling123@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi Guo
Organizational Affiliation
Tianjin Medical University Cancer Institue and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi Guo, PhD
Phone
02223340123
Ext
1095
Email
cjr.guozhi@vip.163.com
First Name & Middle Initial & Last Name & Degree
Tongguo Si, PhD
Phone
02223340123
Ext
1095
Email
sitg77@163.com
12. IPD Sharing Statement
Learn more about this trial
Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer
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