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Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant Chemotherapy in High Risk Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530295
Recruitment Status : Unknown
Verified February 2012 by Hanjong Ahn, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : February 9, 2012
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
Hanjong Ahn, Asan Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: DOCETAXEL Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant in Patients With High Risk Locallized Prostate Cancer
Study Start Date : July 2008
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
No Intervention: contol
control group
 Drug: DOCETAXEL
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 Name: taxotere
chemotherapy
neoadjuvant chemotherapy
 Drug: DOCETAXEL
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 Name: taxotere


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate Cancer
  • PSA > 20 OR
  • Clinical Stage > T2C OR
  • GS > 7
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530295


Contacts
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Contact: HANJONG AHN, MD 82-2-3010-3733 hjahn@amc.seoul.kr, agapeljm@naver.com

Locations
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Korea, Republic of
Jungmin Lee Recruiting
Seoul, Korea, Republic of, 138-731
Contact: jungmin lee, NURSE    82-2-3010-8461    agapeljm@naver.com   
Principal Investigator: hanjong ahn, md         
Sponsors and Collaborators
Hanjong Ahn
Investigators
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Principal Investigator: hanjong Ahn, Ph.D Asan Medical Center
More Information
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Responsible Party: Hanjong Ahn, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01530295    
Other Study ID Numbers: 2007-0326
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Disease Attributes
 Pathologic Processes
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action