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

A Prospective Multi-center Study to Compare the QOL and Efficacy of Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer.

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.

Study Overview

• Status: Unknown
• Conditions: Stage IV Prostate Cancer
• Intervention / Treatment: Drug: luteinizing-hormone releasing-hormone (LHRH) agonist; Procedure: cryoablation; Drug: Bicalutamide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Zhi Guo, PhD; Phone Number: 1095 02223340123; Email: cjr.guozhi@vip.163.com
      • Contact: Tongguo Si, PhD; Phone Number: 1095 02223340123; Email: sitg77@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Drug: luteinizing-hormone releasing-hormone (LHRH) agonist; luteinizing-hormone releasing-hormone (LHRH) agonist; Procedure: cryoablation; Cryoablation therapy; Drug: Bicalutamide; bicalutamide
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: luteinizing-hormone releasing-hormone (LHRH) agonist; luteinizing-hormone releasing-hormone (LHRH) agonist; Drug: Bicalutamide; bicalutamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Median biochemical progression-free survival	It measures the time to biochemical progression (PSA progression).	Within 12 months after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 year
Disease Specific Survival	5 year

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Peking University First Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 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; Tianjin First Central Hospital
• Investigators: Principal Investigator: Zhi Guo, Tianjin Medical University Cancer Institue and Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Androgen Antagonists; Hormones; Bicalutamide; Prolactin Release-Inhibiting Factors
• Other Study ID Numbers: TMU-CIH-IR-005