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Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer (CRYO-PCA-IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02615223
Recruitment Status : Unknown
Verified November 2015 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
First Posted : November 26, 2015
Last Update Posted : June 12, 2017
Sponsor:
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
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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.

Condition or disease Intervention/treatment Phase
Stage IV Prostate Cancer Procedure: cryoablation Drug: Bicalutamide Drug: luteinizing-hormone releasing-hormone (LHRH) agonist Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm1

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.

Procedure: cryoablation
Cryoablation therapy

Drug: Bicalutamide
bicalutamide

Drug: luteinizing-hormone releasing-hormone (LHRH) agonist
luteinizing-hormone releasing-hormone (LHRH) agonist

Experimental: Arm2
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.
Drug: Bicalutamide
bicalutamide

Drug: luteinizing-hormone releasing-hormone (LHRH) agonist
luteinizing-hormone releasing-hormone (LHRH) agonist




Primary Outcome Measures :
  1. Median biochemical progression-free survival [ Time Frame: Within 12 months after treatment ]
    It measures the time to biochemical progression (PSA progression).

  2. 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 [ Time Frame: 3, 6 and 12 months after treatment ]
    European Organization for Research and Treatment of Cancer(EORTC)


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 year ]
  2. Disease Specific Survival [ Time Frame: 5 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615223


Contacts
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Contact: Zhi Guo, PhD 02223340123 ext 1095 cjr.guozhi@vip.163.com
Contact: Xueling Yang 02223340123 ext 1095 yxueling123@163.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Zhi Guo, PhD    02223340123 ext 1095    cjr.guozhi@vip.163.com   
Contact: Tongguo Si, PhD    02223340123 ext 1095    sitg77@163.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
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
Investigators
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Principal Investigator: Zhi Guo Tianjin Medical University Cancer Institue and Hospital
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02615223    
Other Study ID Numbers: TMU-CIH-IR-005
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: November 2015
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Hormones
Prolactin Release-Inhibiting Factors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents