Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer — Open-Label Randomized Clinical Study|
- A composite trifecta endpoint of treatment failure at 3 years after cryoablation [ Time Frame: 3 years ] [ Designated as safety issue: No ]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 to the composite endpoint of treatment failure since cryoablation [ Time Frame: 3 years ] [ Designated as safety issue: No ]Time to the composite endpoint of treatment failure since cryoablation
- Biochemical (PSA) recurrence rate at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]Biochemical (PSA) recurrence rate at 3 years
- Biochemical (PSA) recurrence-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]Biochemical (PSA) recurrence-free survival
- Biopsy-proven recurrence rate at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]Biopsy-proven recurrence rate at 3 years
- Biopsy-proven recurrence-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]Biopsy-proven recurrence-free survival
- Safety profile [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Hormone therapy related toxicities such as liver function alteration, libido changes, alterations in quality of life as measured by QLQ C30 and PR25 questionnaire.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Adjuvant Androgen-Deprivation Therapy
Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy
Drug: Adjuvant Androgen-Deprivation Therapy
Short-term adjuvant androgen-deprivation therapy
Other Name: Adjuvant hormone therapy
No Intervention: No adjuvant therapy
Cryotherapy without any adjuvant therapy
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.
|Contact: Yeong-Shiau Pu, MD, PhD||886-2-23123456 ext email@example.com|
|Contact: Chung-Hsin Chen, MDfirstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Yeong-Shiau Pu, MD, PhD 886-2-23123456 ext 65249 email@example.com|
|Principal Investigator: Yeong-Shiau Pu, MD, PhD|
|Principal Investigator:||Yeong-Shiau Pu, MD, PhD||National Taiwan University Hospital|