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

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
Glenn Bubley, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01250717
First received: November 23, 2010
Last updated: February 27, 2013
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: Docetaxel
Drug: Dexamethasone
Drug: Estramustine
Drug: Zoladex
Drug: Casodex
Procedure: Radical Prostatectomy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Pathologic Complete Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Define the pathologic complete response rate in this patient population. Pathologic CR rate of 10% of higher would be a significant finding which warrants further study.


Secondary Outcome Measures:
  • number of patients with adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Detail the number of adverse events including grade and attribution


Enrollment: 35
Study Start Date: January 2001
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel Followed by Radical Prostatectomy
Docetaxel Followed by Radical Prostatectomy
 Drug: Docetaxel
Given by an IV infusion over 1 hour on day 2 of a three-week cycle
Other Name: Taxotere
Drug: Dexamethasone
Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel
Other Name: Decadron
Drug: Estramustine
Taken orally three times a day for 5 days for the first part of every three week cycle
Drug: Zoladex
Given subcutaneously for 4 doses every three months
Drug: Casodex
Taken orally once a day for 6 months
Procedure: Radical Prostatectomy
after the chemo and hormonal therapy all patients have a radiacal prostatectomy

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250717

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Walter Reed Army Medical Center
Investigators
Principal Investigator: Glenn J. Bubley, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Glenn Bubley, MD, Director Of Genitourinary Oncology @ Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01250717     History of Changes
Other Study ID Numbers: 2001P-001577, E-99-0363-FB
Study First Received: November 23, 2010
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
prostatectomy
docetaxel

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Estramustine
Goserelin
Docetaxel
Bicalutamide
BB 1101
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on June 13, 2013