Spots Global Cancer Trial Database for Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer

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Trial Identification

Brief Title: Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer

Official Title: Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer - Open-Label Randomized Clinical Study

Study ID: NCT01398657

Conditions

Prostate Cancer

Interventions

Adjuvant Androgen-Deprivation Therapy

Study Description

Brief Summary: 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.

Detailed Description: 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.