Status:
UNKNOWN
Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
20+ years
Phase:
PHASE3
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 ...
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 un...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT01398657
Start Date
July 1 2011
End Date
June 1 2016
Last Update
November 14 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan, 100