Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer

Stage IV Prostate Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02615223
• Other study ID #: TMU-CIH-IR-005
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2015
• Last updated: June 9, 2017
• Start date: November 2015
• Est. completion date: December 2018

Study information

• Verified date: November 2015
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Zhi Guo, PhD
• Phone: 02223340123
• Email: cjr.guozhi[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• 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, 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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage IV Prostate Cancer

Intervention

Procedure:
• cryoablation
Cryoablation therapy

Drug:
• Bicalutamide
bicalutamide
• luteinizing-hormone releasing-hormone (LHRH) agonist
luteinizing-hormone releasing-hormone (LHRH) agonist

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (9)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median biochemical progression-free survival	It measures the time to biochemical progression (PSA progression).	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