- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01530295
Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant Chemotherapy in High Risk Prostate Cancer
February 7, 2012 updated by: Hanjong Ahn
Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant in Patients With High Risk Locallized Prostate Cancer
Effect of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer.
The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.
Study Overview
Detailed Description
The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
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: HANJONG AHN, MD
- Phone Number: 82-2-3010-3733
- Email: hjahn@amc.seoul.kr, agapeljm@naver.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 138-731
- Recruiting
- Jungmin Lee
-
Contact:
- jungmin lee, NURSE
- Phone Number: 82-2-3010-8461
- Email: agapeljm@naver.com
-
Principal Investigator:
- hanjong ahn, md
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Prostate Cancer
- PSA > 20 OR
- Clinical Stage > T2C OR
- GS > 7
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
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: contol
control group
|
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle.
Number of Cycles: 3 times pre-op and 3 times after surgery
Other Names:
|
Other: chemotherapy
neoadjuvant chemotherapy
|
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle.
Number of Cycles: 3 times pre-op and 3 times after surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
biochemical recurrence rate of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer
Time Frame: 2 Years After RRP
|
2 Years After RRP
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: hanjong Ahn, Ph.D, Asan Medical Center
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, 2008
Primary Completion (Anticipated)
July 1, 2012
Study Completion (Anticipated)
July 1, 2012
Study Registration Dates
First Submitted
June 22, 2011
First Submitted That Met QC Criteria
February 7, 2012
First Posted (Estimate)
February 9, 2012
Study Record Updates
Last Update Posted (Estimate)
February 9, 2012
Last Update Submitted That Met QC Criteria
February 7, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-0326
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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