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

NCT ID: NCT01530295

Last Updated: 2012-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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contol

control group

Group Type NO_INTERVENTION

DOCETAXEL

Intervention Type DRUG

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

chemotherapy

neoadjuvant chemotherapy

Group Type OTHER

DOCETAXEL

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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taxotere

Eligibility Criteria

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Inclusion Criteria

* Prostate Cancer
* PSA \> 20 OR
* Clinical Stage \> T2C OR
* GS \> 7
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hanjong Ahn

OTHER

Sponsor Role lead

Responsible Party

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Hanjong Ahn

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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hanjong Ahn, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Jungmin Lee

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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HANJONG AHN, MD

Role: CONTACT

Facility Contacts

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jungmin lee, NURSE

Role: primary

82-2-3010-8461

Other Identifiers

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2007-0326

Identifier Type: -

Identifier Source: org_study_id

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