Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00888654
Recruitment Status : Completed
First Posted : April 27, 2009
Results First Posted : March 30, 2015
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elisabeth Heath, Barbara Ann Karmanos Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: B-Dim
Procedure: Radical Prosatectomy
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title B-Dim, Radical Prosatectomy
Hide Arm/Group Description

B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prostatectomy

B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prosatectomy

Period Title: Overall Study
Started 41
Completed 31
Not Completed 10
Reason Not Completed
Problems swallowing oral meds.             1
Not enough oral meds before surgery             3
Surgery aborted             2
Withdrawal by Subject             1
Inelig. due to contraindication of med             1
Change in surg date             1
Stopped meds due to headaches             1
Arm/Group Title B-Dim, Radical Prosatectomy
Hide Arm/Group Description

B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prostatectomy

B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prosatectomy

Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants
58
(20 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
0
   0.0%
Male
41
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants
41
1.Primary Outcome
Title Mean Level of Diindolylmethane in Prostate Tissue After Treatment
Hide Description [Not Specified]
Time Frame Within the first 24 months after radical prostatectomy.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that were eligible, evaluable, and compliant
Arm/Group Title B-Dim, Radical Prosatectomy
Hide Arm/Group Description:

B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prostatectomy

B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prosatectomy

Overall Number of Participants Analyzed 28
Mean (90% Confidence Interval)
Unit of Measure: ng/g
14.2
(10.6 to 17.7)
2.Secondary Outcome
Title Serum Levels of PSA, Testosterone, and Diindolylmethane
Hide Description Serum levels of PSA, testosterone, and diindolylmethane (DIM)
Time Frame Pre and post radical prostatectomy
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery.
Arm/Group Title B-Dim, Radical Prosatectomy
Hide Arm/Group Description:

B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prostatectomy

B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prosatectomy

Overall Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: ng/ml
Pre-treatment PSA
6.4
(2.1 to 29.4)
Post-treatment PSA
5.8
(2.6 to 28.3)
Pre-treatment Testosterone
301
(77 to 608)
Post-treatment Testosterone
388
(110 to 686)
Pre-treatment DIM
0.0
(0.0 to 0.0)
Post-treatment DIM
7.5
(0.0 to 24.7)
3.Secondary Outcome
Title Levels of Androgen Receptor in Prostate Tissue
Hide Description Levels of androgen receptor in prostate tissue as measured by AR score (intensity x % cells stained), higher scores indicate higher levels of androgen receptor in prostate tissue.
Time Frame Pre and post radical prostatectomy
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery.
Arm/Group Title B-Dim, Radical Prosatectomy
Hide Arm/Group Description:

B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prostatectomy

B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prosatectomy

Overall Number of Participants Analyzed 39
Mean (90% Confidence Interval)
Unit of Measure: AR score (intensity x % cells stained)
Pre-BR-DIM Androgen Receptor
278
(263 to 293)
Post-BR-DIM Androgen Receptor
245
(227 to 263)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title B-Dim, Radical Prosatectomy
Hide Arm/Group Description

B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prostatectomy

B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prosatectomy

All-Cause Mortality
B-Dim, Radical Prosatectomy
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
B-Dim, Radical Prosatectomy
Affected / at Risk (%) # Events
Total   2/41 (4.88%)    
Nervous system disorders   
Headache  1  2/41 (4.88%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
B-Dim, Radical Prosatectomy
Affected / at Risk (%) # Events
Total   0/41 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elisabeth Heath, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8715
EMail: heathe@karmanos.org
Layout table for additonal information
Responsible Party: Elisabeth Heath, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00888654    
Other Study ID Numbers: CDR0000641168
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2007-128
First Submitted: April 24, 2009
First Posted: April 27, 2009
Results First Submitted: March 23, 2015
Results First Posted: March 30, 2015
Last Update Posted: March 19, 2018