Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

NCT ID: NCT01250717

Last Updated: 2014-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2011-05-31

Brief Summary

The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.

Detailed Description

• Participants will receive treatment in the outpatient clinic, where the docetaxel chemotherapy will be placed in a bag of fluid and will be given by vein every three weeks. Participants will take Decadron (dexamethasone) by mouth 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel. They will also take estramustine and casodex by mouth at home. Zoladex (or lupron) will be given subcutaneously (under the skin) 4 times every three months. They will also be started on coumadin beginning at the time of the first docetaxel infusion and continuing until 3 weeks after the 4th cycle of chemotherapy.
• After 2 months (or cycles) of therapy, participants will be evaluated in order to assess the response and toxicity of treatment, including a review of medical history, physical examination, blood tests, including PSA. If there is no evidence of progression or excessive toxicity, treatment will continue for 2 more months in the same manner.
• At the end of 4 months of chemotherapy, participants will be reassessed by the medical oncologist and urologist regarding surgery to remove the prostate.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel Followed by Radical Prostatectomy

Docetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Given by an IV infusion over 1 hour on day 2 of a three-week cycle

Dexamethasone

Intervention Type: DRUG

Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel

Estramustine

Intervention Type: DRUG

Taken orally three times a day for 5 days for the first part of every three week cycle

Zoladex

Intervention Type: DRUG

Given subcutaneously for 4 doses every three months

Casodex

Intervention Type: DRUG

Taken orally once a day for 6 months

Radical Prostatectomy

Intervention Type: PROCEDURE

after the chemo and hormonal therapy all patients have a radiacal prostatectomy

Interventions

Docetaxel

Given by an IV infusion over 1 hour on day 2 of a three-week cycle

Intervention Type: DRUG

Dexamethasone

Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel

Intervention Type: DRUG

Estramustine

Taken orally three times a day for 5 days for the first part of every three week cycle

Intervention Type: DRUG

Zoladex

Given subcutaneously for 4 doses every three months

Intervention Type: DRUG

Casodex

Taken orally once a day for 6 months

Intervention Type: DRUG

Radical Prostatectomy

after the chemo and hormonal therapy all patients have a radiacal prostatectomy

Intervention Type: PROCEDURE

Other Intervention Names

Taxotere; Decadron; goserelin acetate; Bicalutamide

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed adenocarcinoma of the prostate
• Potential candidate for radical prostatectomy
• Any of the following: a) clinical stage T3 patients, b) Serum PSA greater than or equal to 20 ng/ml, c) Gleason score 8-10, d) Clinical T2 disease and either MRI evidence of seminal vesicle involvement or Gleason 4+3 cancer with either 5 or 6 biopsies positive
• ECOG Performance Status 0-1
• WBC > 3,000 ul
• HCT > 30%
• PLT > 100,000/ul
• LFTS within normal limits

Exclusion Criteria

• Prior hormones, radiation or chemotherapy for prostate cancer
• Myocardial infarction within 1 year, significant change in anginal pattern within last 6 months, current congestive heart failure (NYHA Class 2 or higher), or deep venous thrombosis within 1 year
• Evidence of active infection
• Significant peripheral neuropathy

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Glenn Bubley, MD

Director Of Genitourinary Oncology @ Beth Israel Deaconess Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glenn J. Bubley, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

E-99-0363-FB

Identifier Type: OTHER

Identifier Source: secondary_id

2001P-001577

Identifier Type: -

Identifier Source: org_study_id