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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Docetaxel
Drug: Dexamethasone
Drug: Estramustine
Drug: Zoladex
Drug: Casodex
Procedure: Radical Prostatectomy
Enrollment 28
Recruitment Details Between September 28, 1999 and May 17, 2005, 28 participants with high risk localized prostate cancer were enrolled on this IRB approved phase II protocol from BIDMC Urology clinics
Pre-assignment Details This was a single arm study and there were no arms. Participants were screened for final eligibility after consent was completed. All enrolled subjects were treated
Arm/Group Title Docetaxel Followed by Radical Prostatectomy
Hide Arm/Group Description

This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.

Docetaxel Followed by Radical Prostatectomy

Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy

Zoladex : Given subcutaneously for 4 doses every three months

Casodex : Taken orally once a day for 6 months

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

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

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

Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title Docetaxel Followed by Radical Prostatectomy
Hide Arm/Group Description

This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.

Docetaxel Followed by Radical Prostatectomy

Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy

Zoladex : Given subcutaneously for 4 doses every three months

Casodex : Taken orally once a day for 6 months

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

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

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

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants
57
(43 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
0
   0.0%
Male
28
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists
Hide Description 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.
Time Frame status post prostectomy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docetaxel Followed by Radical Prostatectomy
Hide Arm/Group Description:

This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.

Docetaxel Followed by Radical Prostatectomy

Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy

Zoladex : Given subcutaneously for 4 doses every three months

Casodex : Taken orally once a day for 6 months

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

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

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

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel Followed by Radical Prostatectomy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0.12
Estimation Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description followed for four cycles of therapy
 
Arm/Group Title Docetaxel Followed by Radical Prostatectomy
Hide Arm/Group Description

This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.

Docetaxel Followed by Radical Prostatectomy

Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy

Zoladex : Given subcutaneously for 4 doses every three months

Casodex : Taken orally once a day for 6 months

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

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

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

All-Cause Mortality
Docetaxel Followed by Radical Prostatectomy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel Followed by Radical Prostatectomy
Affected / at Risk (%) # Events
Total   5/28 (17.86%)    
Blood and lymphatic system disorders   
neutropenic fever  [1]  4/28 (14.29%)  4
Hepatobiliary disorders   
elevated liver functions  [2]  1/28 (3.57%)  1
Indicates events were collected by systematic assessment
[1]
defined as ANC < 500 and fever over 100 degrees farenheit
[2]
assessment by ALT and AST levels with 3.0 common toxicity criteria
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Docetaxel Followed by Radical Prostatectomy
Affected / at Risk (%) # Events
Total   0/28 (0.00%)    
Although this study has the longest median follow-up periods reported (80 months or 6.6 years), the overall number of participants is too few to make strong judgements about efficacy
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Glenn Bubley MD, Director of GU ONC
Organization: BIDMC
Phone: 617-735-2062
EMail: gbubley@bidmc.harvard.edu
Layout table for additonal information
Responsible Party: Glenn Bubley, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01250717     History of Changes
Other Study ID Numbers: 2001P-001577
E-99-0363-FB ( Other Identifier: BIDMC IRB )
First Submitted: November 23, 2010
First Posted: December 1, 2010
Results First Submitted: July 1, 2013
Results First Posted: February 4, 2014
Last Update Posted: February 4, 2014