Patients with primary diagnosed metastatic prostate cancer are randomly divided into two groups. One group receive standard of care ADT continually. Another group receive ADT plus prostate cryotherapy. Patients are followed up until their death or withdraw from this study due to other reasons. The primary endpoint of this study is prostate cancer Progression-Free Survival. The secondary endpoint is overall survival, prostate cancer specific survival and health-related quality of life.
Ages Eligible for Study: 18 Years and older. Genders Eligible for Study: Male. Accepts Healthy Volunteers: No.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
prostate cryotherapy added to experimental group within 6 months of ADT
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProstate Cancer Progression-Free Survival
Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer
Time frame: through study completion, an average of 48 months
Overall Survival
Overall Survival (OS), from beginning of ADT to death
Time frame: through study completion, an average of 60 months
prostate cancer specific survival
prostate cancer specific survival (CSS), from beginning of ADT to death from prostate cancer
Time frame: through study completion, an average of 60 months
Functional Assessment of Cancer Therapy-Prostate
Functional Assessment of Cancer Therapy-Prostate (FACT-P), From beginning of ADT to death
Time frame: through study completion, an average of 48 months
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