A Prospective Multi-center Study to Compare the QOL and Efficacy of External Beam Radiation Therapy or Cryoablation Therapy for Stage III Prostate Cancer
Overview
- Phase
- N/A
- Intervention
- Cryoablation therapy
- Conditions
- Stage III Prostate Cancer
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- 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
- Last Updated
- 8 years ago
Overview
Brief Summary
This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with radiotherapy or 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Prostate adenocarcinoma, T3aN0M0, T3bN0M0
- •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
Arms & Interventions
Arm I
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.
Intervention: Cryoablation therapy
Arm I
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.
Intervention: bicalutamide
Arm I
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.
Intervention: luteinizing-hormone releasing-hormone (LHRH) agonist
Arm II
Patients receive androgen ablation as in arm I. Patients receive external beam radiation therapy.
Intervention: External beam radiation therapy
Arm II
Patients receive androgen ablation as in arm I. Patients receive external beam radiation therapy.
Intervention: bicalutamide
Arm II
Patients receive androgen ablation as in arm I. Patients receive external beam radiation therapy.
Intervention: luteinizing-hormone releasing-hormone (LHRH) agonist
Outcomes
Primary Outcomes
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
Time Frame: 3, 6 and 12 months after treatment
European Organization for Research and Treatment of Cancer(EORTC)
Median PSA progression-free survival in patients responding to the study treatments
Time Frame: Within 12 months after treatment
Secondary Outcomes
- Disease Specific Survival(5 year)
- Overall survival(5 year)