Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant Chemotherapy in High Risk Prostate Cancer
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Jul 2008
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 22, 2011
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFebruary 9, 2012
February 1, 2012
4 years
June 22, 2011
February 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
biochemical recurrence rate of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer
2 Years After RRP
Study Arms (2)
contol
NO INTERVENTIONcontrol group
chemotherapy
OTHERneoadjuvant chemotherapy
Interventions
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
Eligibility Criteria
You may qualify if:
- Prostate Cancer
- PSA \> 20 OR
- Clinical Stage \> T2C OR
- GS \> 7
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hanjong Ahnlead
Study Sites (1)
Jungmin Lee
Seoul, Seoul, 138-731, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
hanjong Ahn, Ph.D
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 22, 2011
First Posted
February 9, 2012
Study Start
July 1, 2008
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
February 9, 2012
Record last verified: 2012-02