Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer

Not Applicable

• Conditions: Stage IV Prostate Cancer
• Interventions: Procedure: cryoablation; Drug: Bicalutamide; Drug: luteinizing-hormone releasing-hormone (LHRH) agonist

• Registration Number: NCT02615223
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2015-11
• Study Start: 2015-11
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-26
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm1	luteinizing-hormone releasing-hormone (LHRH) agonist	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.
Arm1	cryoablation	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.
Arm2	luteinizing-hormone releasing-hormone (LHRH) agonist	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.
Arm1	Bicalutamide	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.
Arm2	Bicalutamide	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.

Primary Outcome Measures

Name	Time	Method
Median biochemical progression-free survival	Within 12 months after treatment	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	3, 6 and 12 months after treatment	European Organization for Research and Treatment of Cancer(EORTC)

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 year
Disease Specific Survival	5 year

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China