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Trial record 28 of 279 for:    prostate cancer AND localized | ( Map: United States )

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

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ClinicalTrials.gov Identifier: NCT01250717
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
Glenn Bubley, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE November 23, 2010
First Posted Date  ICMJE December 1, 2010
Results First Submitted Date  ICMJE July 1, 2013
Results First Posted Date  ICMJE February 4, 2014
Last Update Posted Date February 4, 2014
Study Start Date  ICMJE January 2001
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists [ Time Frame: status post prostectomy ]
One of two pathologists (SR, EG), assigned the Gleason scores for each patient from pre-treatment prostate biopsies and assessed pathological staging on post- prostatectomy specimens. Staging including a description of all tumor foci within the gland, presence or absence of perineural invasion and/or lymphovascular invasion, presence of extraprostatic extension of tumor (including seminal vesicle invasion), and margin status. The pathologists reviewed the presence or absence of cancer in each prostate gland removed on the study patients. RECIST has to my knowledge not been used for pathological examination in neoadjuvant studies. 0 out of 28 participants acheived complete response. RECIST is not appropriate as cancer within the gland at the time of treatment is not measurable by RECIST. The primary outcome is a pathological complete response.
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2010)
Pathologic Complete Response [ Time Frame: 2 years ]
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.
Change History Complete list of historical versions of study NCT01250717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2010)
Toxicity [ Time Frame: 2 years ]
Describe the toxicity of this study intervention.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
Official Title  ICMJE Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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
    Other Name: goserelin acetate
  • Drug: Casodex
    Taken orally once a day for 6 months
    Other Name: Bicalutamide
  • Procedure: Radical Prostatectomy
    after the chemo and hormonal therapy all patients have a radiacal prostatectomy
Study Arms  ICMJE Experimental: Docetaxel Followed by Radical Prostatectomy
Docetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy
Interventions:
  • Drug: Docetaxel
  • Drug: Dexamethasone
  • Drug: Estramustine
  • Drug: Zoladex
  • Drug: Casodex
  • Procedure: Radical Prostatectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2013)
28
Original Actual Enrollment  ICMJE
 (submitted: November 29, 2010)
35
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01250717
Other Study ID Numbers  ICMJE 2001P-001577
E-99-0363-FB ( Other Identifier: BIDMC IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Glenn Bubley, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Walter Reed Army Medical Center
Investigators  ICMJE
Principal Investigator: Glenn J. Bubley, MD Beth Israel Deaconess Medical Center
PRS Account Dana-Farber Cancer Institute
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP