- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398657
Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer
November 13, 2012 updated by: National Taiwan University Hospital
Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer - Open-Label Randomized Clinical Study
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
182
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yeong-Shiau Pu, MD, PhD
- Phone Number: 65249 886-2-23123456
- Email: yspu@ntu.edu.tw
Study Contact Backup
- Name: Chung-Hsin Chen, MD
- Phone Number: +886-922226230
- Email: duoncin.dan@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Yeong-Shiau Pu, MD, PhD
- Phone Number: 65249 886-2-23123456
- Email: yspu@ntu.edu.tw
-
Principal Investigator:
- Yeong-Shiau Pu, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Age>20 years
- Histopathology proven prostate adenocarcinoma
- Non-metastatic localized disease
- Prostate cancer is deemed high-risk for recurrence(PSA>20 ng/ml, Gleason score>=8, or clinical staging>=T2c)
- Subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study
- 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.
- 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.
- Subjects are willing to sign the informed consent and agree to comply with the study procedures
Exclusion Criteria:
- Those who have been treated with > 8 weeks (collectively if not continuously) of neoadjuvant ADT prior to screening.
- 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
- Other conditions the investigators think may affect subject compliance or safety
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adjuvant Androgen-Deprivation Therapy
Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy
|
Short-term adjuvant androgen-deprivation therapy
Other Names:
|
No Intervention: No adjuvant therapy
Cryotherapy without any adjuvant therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A composite trifecta endpoint of treatment failure at 3 years after cryoablation
Time Frame: 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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to the composite endpoint of treatment failure since cryoablation
Time Frame: 3 years
|
Time to the composite endpoint of treatment failure since cryoablation
|
3 years
|
Biochemical (PSA) recurrence rate at 3 years
Time Frame: 3 years
|
Biochemical (PSA) recurrence rate at 3 years
|
3 years
|
Biochemical (PSA) recurrence-free survival
Time Frame: 3 years
|
Biochemical (PSA) recurrence-free survival
|
3 years
|
Biopsy-proven recurrence rate at 3 years
Time Frame: 3 years
|
Biopsy-proven recurrence rate at 3 years
|
3 years
|
Biopsy-proven recurrence-free survival
Time Frame: 3 years
|
Biopsy-proven recurrence-free survival
|
3 years
|
Safety profile
Time Frame: 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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
June 1, 2014
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
July 14, 2011
First Submitted That Met QC Criteria
July 19, 2011
First Posted (Estimate)
July 20, 2011
Study Record Updates
Last Update Posted (Estimate)
November 14, 2012
Last Update Submitted That Met QC Criteria
November 13, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201103057MB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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