Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery

This study has been completed.
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00438464
First received: February 20, 2007
Last updated: February 10, 2016
Last verified: June 2015
Results First Received: October 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Prostate
Stage II Prostate Cancer
Interventions: Drug: Finasteride
Other: Placebo
Procedure: Prostatectomy
Other: Laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: From 2007 to 2012 recruitment was done at various medical clinic locations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 210 participants recruited, 204 were randomized to the study.

Reporting Groups
  Description
Arm I (Finasteride) Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Arm II (Placebo) Placebo once daily for 4-6 weeks, then undergo prostatectomy.

Participant Flow:   Overall Study
    Arm I (Finasteride)     Arm II (Placebo)  
STARTED     103     101  
Received Assigned Intervention     89     94  
COMPLETED     89     94  
NOT COMPLETED     14     7  
Terminated Early                 14                 5  
Incomplete data submission                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline includes participants who were randomized to arms and received assigned treatment.

Reporting Groups
  Description
Arm I (Finasteride) Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Arm II (Placebo) Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Total Total of all reporting groups

Baseline Measures
    Arm I (Finasteride)     Arm II (Placebo)     Total  
Number of Participants  
[units: participants]
  89     94     183  
Age  
[units: years]
Median (Full Range)
  59   (45 to 73)     62   (48 to 73)     60   (45 to 73)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     89     94     183  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     1     0     1  
Black     5     7     12  
Hispanic     5     2     7  
White     78     85     163  
Region of Enrollment  
[units: participants]
     
United States     89     94     183  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy   [ Time Frame: At prostatectomy following maximum 6 week treatment period ]

2.  Primary:   Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy   [ Time Frame: At prostatectomy following maximum 6 week treatment period ]

3.  Primary:   Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy   [ Time Frame: At prostatectomy following maximum 6 week treatment period. ]

4.  Primary:   Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy   [ Time Frame: At prostatectomy following maximum 6 week treatment period. ]

5.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score   [ Time Frame: Assessment following maximum 6 week treatment period and prostatectomy ]

6.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)   [ Time Frame: Assessment following maximum 6 week treatment period and prostatectomy ]

7.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)   [ Time Frame: Assessment following maximum 6 week treatment period and prostatectomy ]

8.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage   [ Time Frame: Assessment following maximum 6 week treatment period and prostatectomy ]

9.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)   [ Time Frame: Assessment following maximum 6 week treatment period and prostatectomy ]

10.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status   [ Time Frame: Assessment following maximum 6 week treatment period and prostatectomy ]

11.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci   [ Time Frame: Assessment following maximum 6 week treatment period and prostatectomy ]

12.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)   [ Time Frame: Assessment following maximum 6 week treatment period and prostatectomy ]

13.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus   [ Time Frame: Assessment following maximum 6 week treatment period and prostatectomy ]

14.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy   [ Time Frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period ]

15.  Secondary:   Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)   [ Time Frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period ]

16.  Secondary:   Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)   [ Time Frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period ]

17.  Secondary:   Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change   [ Time Frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period ]

18.  Secondary:   Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change   [ Time Frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period ]

19.  Secondary:   Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change   [ Time Frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period ]

20.  Secondary:   Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change   [ Time Frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period ]

21.  Secondary:   Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)   [ Time Frame: At prostatectomy following maximum 6 week treatment period ]

22.  Secondary:   Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)   [ Time Frame: At prostatectomy following maximum 6 week treatment period. ]

23.  Secondary:   Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups   [ Time Frame: At prostatectomy following maximum 6 week treatment period ]

24.  Secondary:   Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups   [ Time Frame: At prostatectomy following maximum 6 week treatment period. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Predefined molecular signature could not easily distinguish GG 4 from GG 3 tumor areas in the placebo arm.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeri Kim, MD / Associate Professor, Genitourinary Medical Oncology
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-2830
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00438464     History of Changes
Other Study ID Numbers: NCI-2009-00856
NCI-2009-00856 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000653463
2006-0614 ( Other Identifier: M D Anderson Cancer Center )
MDA03-1-03 ( Other Identifier: DCP )
N01CN35159 ( US NIH Grant/Contract Award Number )
P30CA016672 ( US NIH Grant/Contract Award Number )
Study First Received: February 20, 2007
Results First Received: October 20, 2015
Last Updated: February 10, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government