This is an open-label randomized clinical study comparing primary prostate cryoablation alone (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer.
Subjects (N=182) who have high-risk prostate cancer and have undergone primary prostate cryotherapy will be screened and randomized in a 1:1 ratio to receive either adjuvant ADT (Adj-ADT) or No-ADT until disease progression. Screening and randomization will be done within four weeks after cryoablation. Only those who are assigned to Adj-ADT will receive ADT for a total of 12 months. PSA will be checked every 3 months in the first year after Cryo and every 6 months thereafter. Long-term follow-up parameters include serum PSA and protocol-mandated biopsies (at 36 months after Cryo, irrespective of PSA levels if recurrence has not been documented). For-cause biopsy will also be done if post-Cryo PSA elevation reaches the Phoenix criteria (Nadir + 2 ng/ml) or when the treating physician thinks it necessary to document tumor recurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Short-term adjuvant androgen-deprivation therapy
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGA composite trifecta endpoint of treatment failure at 3 years after cryoablation
A composite trifecta endpoint of treatment failure at 3 years after cryoablation defined by either of the three, biochemical (PSA) recurrence (by the Phoenix criteria) or biopsy-proven recurrence or initiation of hormone therapy for disease recurrence whichever comes first.
Time frame: 3 years
Time to the composite endpoint of treatment failure since cryoablation
Time to the composite endpoint of treatment failure since cryoablation
Time frame: 3 years
Biochemical (PSA) recurrence rate at 3 years
Biochemical (PSA) recurrence rate at 3 years
Time frame: 3 years
Biochemical (PSA) recurrence-free survival
Biochemical (PSA) recurrence-free survival
Time frame: 3 years
Biopsy-proven recurrence rate at 3 years
Biopsy-proven recurrence rate at 3 years
Time frame: 3 years
Biopsy-proven recurrence-free survival
Biopsy-proven recurrence-free survival
Time frame: 3 years
Safety profile
Hormone therapy related toxicities such as liver function alteration, libido changes, alterations in quality of life as measured by QLQ C30 and PR25 questionnaire.
Time frame: 3 years
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