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 because the information has not been verified recently.
Verified February 2012 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hanjong Ahn, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01530295
First received: June 22, 2011
Last updated: February 7, 2012
Last verified: February 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hanjong Ahn, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01530295     History of Changes
Other Study ID Numbers: 2007-0326
Study First Received: June 22, 2011
Last Updated: February 7, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014