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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Hanjong Ahn, Asan Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01530295
First Posted: February 9, 2012
Last Update Posted: February 9, 2012
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.
Information provided by (Responsible Party):
Hanjong Ahn, Asan Medical Center
  Purpose

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 Intervention
Prostate Cancer Drug: DOCETAXEL

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hanjong Ahn, Asan Medical Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: July 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
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
Contact: HANJONG AHN, MD 82-2-3010-3733 hjahn@amc.seoul.kr, agapeljm@naver.com

Locations
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
Principal Investigator: hanjong Ahn, Ph.D Asan Medical Center
  More Information

Responsible Party: Hanjong Ahn, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01530295     History of Changes
Other Study ID Numbers: 2007-0326
First Submitted: June 22, 2011
First Posted: February 9, 2012
Last Update Posted: February 9, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes