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

Phase 3

• Conditions: Prostate Cancer
• Interventions: Drug: Adjuvant Androgen-Deprivation Therapy

• Registration Number: NCT01398657
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Status Verified: 2012-03
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14
• Primary Completion: 2014-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 182

Inclusion Criteria

1. Age>20 years
2. Histopathology proven prostate adenocarcinoma
3. Non-metastatic localized disease
4. Prostate cancer is deemed high-risk for recurrence(PSA>20 ng/ml, Gleason score>=8, or clinical staging>=T2c)
5. Subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study
6. Subjects who have not been treated with any definitive treatments for prostate cancer, including radical prostatectomy or definitive radiotherapy. However, those who have undergone focal prostate cryoablation and have cancer recurrence are still eligible.
7. Subjects may or may not have received neoadjuvant androgen-deprivation therapy (ADT) in the forms of either castration (medical) and/or antiandrogens. Surgical castration (orchiectomy) is not allowed.
8. Subjects are willing to sign the informed consent and agree to comply with the study procedures

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Exclusion Criteria

1. Those who have been treated with > 8 weeks (collectively if not continuously) of neoadjuvant ADT prior to screening.
2. Subjects who have other cancer that is deemed not cured or are known less than 5 years except for basal cell carcinoma of the skin
3. Other conditions the investigators think may affect subject compliance or safety

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant Androgen-Deprivation Therapy	Adjuvant Androgen-Deprivation Therapy	Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy

Primary Outcome Measures

Name	Time	Method
A composite trifecta endpoint of treatment failure at 3 years after cryoablation	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Time to the composite endpoint of treatment failure since cryoablation	3 years	Time to the composite endpoint of treatment failure since cryoablation
Biochemical (PSA) recurrence-free survival	3 years	Biochemical (PSA) recurrence-free survival
Biochemical (PSA) recurrence rate at 3 years	3 years	Biochemical (PSA) recurrence rate at 3 years
Biopsy-proven recurrence rate at 3 years	3 years	Biopsy-proven recurrence rate at 3 years
Biopsy-proven recurrence-free survival	3 years	Biopsy-proven recurrence-free survival
Safety profile	3 years	Hormone therapy related toxicities such as liver function alteration, libido changes, alterations in quality of life as measured by QLQ C30 and PR25 questionnaire.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan