Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer (CRYO-PCA-IV)

Tianjin Medical University

Status: Unknown

Conditions: Stage IV Prostate Cancer

Treatments: Drug: Bicalutamide; Procedure: cryoablation; Drug: luteinizing-hormone releasing-hormone (LHRH) agonist

Study type: Interventional

Funder types: Other

Identifiers

NCT02615223

TMU-CIH-IR-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Arm1

Experimental group

Description:

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.

Treatment:

Drug: luteinizing-hormone releasing-hormone (LHRH) agonist

Drug: Bicalutamide

Procedure: cryoablation

Arm2

Experimental group

Description:

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.

Treatment:

Drug: luteinizing-hormone releasing-hormone (LHRH) agonist

Drug: Bicalutamide