Clinical trial NCT02615223: Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stage IV Prostate Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Tianjin First Central Hospital
name: Shandong Cancer Hospital and Institute
name: Shanghai Jiao Tong University School of Medicine
name: The Third Xiangya Hospital of Central South University
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2015-11-26
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Median biochemical progression-free survival
timeFrame: Within 12 months after treatment
measure: 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
timeFrame: 3, 6 and 12 months after treatment
Secondary outcomes:
measure: Overall survival
timeFrame: 5 year
measure: Disease Specific Survival
timeFrame: 5 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institue and Hospital
name: Zhi Guo
role: PRINCIPAL_INVESTIGATOR
References: