Overview

This trial is active, not recruiting.

Condition stage iii prostate cancer
Treatments cryoablation therapy, external beam radiation therapy, bicalutamide, luteinizing-hormone releasing-hormone (lhrh) agonist
Sponsor Tianjin Medical University Cancer Institute and Hospital
Collaborator The Third Xiangya Hospital of Central South University
Start date November 2015
End date December 2016
Trial size 240 participants
Trial identifier NCT02605226, TMU-CIH-IR-004

Summary

This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with radiotherapy or cryoablation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
cryoablation therapy
Cryoablation therapy
bicalutamide
bicalutamide
luteinizing-hormone releasing-hormone (lhrh) agonist
luteinizing-hormone releasing-hormone (LHRH) agonist
(Experimental)
Patients receive androgen ablation as in arm I. Patients receive external beam radiation therapy.
external beam radiation therapy
External beam radiation therapy
bicalutamide
bicalutamide
luteinizing-hormone releasing-hormone (lhrh) agonist
luteinizing-hormone releasing-hormone (LHRH) agonist

Primary Outcomes

Measure
Median PSA progression-free survival in patients responding to the study treatments
time frame: 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
time frame: 3, 6 and 12 months after treatment

Secondary Outcomes

Measure
Overall survival
time frame: 5 year
Disease Specific Survival
time frame: 5 year

Eligibility Criteria

Male participants from 18 years up to 80 years old.

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

Additional Information

Official title A Prospective Multi-center Study to Compare the QOL and Efficacy of External Beam Radiation Therapy or Cryoablation Therapy for Stage III Prostate Cancer
Principal investigator Zhi Guo, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Tianjin Medical University Cancer Institute and Hospital.