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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01398657
• Other study ID #: 201103057MB
• Status: Recruiting
• Phase: Phase 3
• First received: July 14, 2011
• Last updated: November 13, 2012
• Start date: July 2011
• Est. completion date: June 2016

Study information

• Verified date: March 2012
• Source: National Taiwan University Hospital
• Contact: Yeong-Shiau Pu, MD, PhD
• Phone: 886-2-23123456
• Email: yspu[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: June 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Adjuvant Androgen-Deprivation Therapy
Short-term adjuvant androgen-deprivation therapy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A 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.	3 years	No
Secondary	Time to the composite endpoint of treatment failure since cryoablation	Time to the composite endpoint of treatment failure since cryoablation	3 years	No
Secondary	Biochemical (PSA) recurrence rate at 3 years	Biochemical (PSA) recurrence rate at 3 years	3 years	No
Secondary	Biochemical (PSA) recurrence-free survival	Biochemical (PSA) recurrence-free survival	3 years	No
Secondary	Biopsy-proven recurrence rate at 3 years	Biopsy-proven recurrence rate at 3 years	3 years	No
Secondary	Biopsy-proven recurrence-free survival	Biopsy-proven recurrence-free survival	3 years	No
Secondary	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.	3 years	Yes