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

This study is currently recruiting participants.
Verified February 2012 by Asan Medical Center
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
History of Changes
  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:

Drug Information available for: Docetaxel
U.S. FDA Resources

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
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
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013