Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer

Study Overview
=================
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.

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.

Conditions
-----------------
Stage IV Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: cryoablation
* Drug: Bicalutamide
* Drug: luteinizing-hormone releasing-hormone (LHRH) agonist


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1<br>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<br>* Cryoablation therapy<br>Drug: Bicalutamide<br>* bicalutamide<br>Drug: luteinizing-hormone releasing-hormone (LHRH) agonist<br>* luteinizing-hormone releasing-hormone (LHRH) agonist<br>|
| Experimental: Arm2<br>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<br>* bicalutamide<br>Drug: luteinizing-hormone releasing-hormone (LHRH) agonist<br>* luteinizing-hormone releasing-hormone (LHRH) agonist<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 year | 
| Disease Specific Survival |  | 5 year |