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Genistein in Treating Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01126879
Recruitment Status : Terminated (Closed due to low accrual)
First Posted : May 20, 2010
Results First Posted : July 2, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage III Prostate Cancer
Interventions Dietary Supplement: genistein
Other: placebo
Procedure: therapeutic conventional surgery
Enrollment 12
Recruitment Details The study opened on October 21, 2010 with an accrual goal of 30 patients with firs the patient enrolled March 3, 2011. The study was designed as a randomized blinded drug/placebo study but was amended to a single arm drug study and accrual reduced to 18. Study closed permanently on May 28, 2014 due to low accrual with 12 patients treated on study.
Pre-assignment Details Patients entered the study and were treated in a double blinded fashion with a ration of 2:1 Genistein:Placebo. Unblinding occured if it was medically necessary otherwise blinding was maintained until the time of data review.
Arm/Group Title Arm I - Genistein Arm II - Placebo
Hide Arm/Group Description

Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Genistein: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Placebo: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Period Title: Overall Study
Started 8 4
Started 3 Months of Genistein/Placebo 8 4
Prostatectomy or Radiation 8 4
Completed 3 Months Genistein/Placebo 4 2
Completed 3 2
Not Completed 5 2
Reason Not Completed
Progressive Disease             3             1
Withdrawal by Subject             1             0
Adverse Event             0             1
Physician Decision             1             0
Arm/Group Title Arm I - Genistein Arm II - Placebo Total
Hide Arm/Group Description

Patients receive oral genistein or placebo once daily for 3 months beginning at least 2 weeks prior to radical prostatectomy.

Genistein: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Patients receive oral genistein or placebo once daily for 3 months beginning at least 2 weeks prior to radical prostatectomy.

Placebo: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Total of all reporting groups
Overall Number of Baseline Participants 8 4 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  62.5%
2
  50.0%
7
  58.3%
>=65 years
3
  37.5%
2
  50.0%
5
  41.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
4
 100.0%
12
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
Hispanic or Latino
0
   0.0%
1
  25.0%
1
   8.3%
Not Hispanic or Latino
8
 100.0%
3
  75.0%
11
  91.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
8
 100.0%
4
 100.0%
12
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants 4 participants 12 participants
8
 100.0%
4
 100.0%
12
 100.0%
1.Primary Outcome
Title Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs
Hide Description Blood will be collected to analyze the number of CPC's at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.
Time Frame At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.
Arm/Group Title Arm I - Genistein Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Genistein: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Placebo: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy
Hide Description Blood will be drawn to analyze the natural history of circulating prostate cells (CPCs) in a cohort of subjects at baseline and 1 and 12 months after surgery.
Time Frame At baseline, 1 and 12 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.
Arm/Group Title Arm I - Genistein Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Genistein: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Placebo: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue
Hide Description At baseline and time of surgery, tissue will be collected to measure the effect of genistein on select gene and protein expressions in prostate tissue.
Time Frame At baseline and at time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.
Arm/Group Title Arm I - Genistein Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Genistein: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Placebo: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Measurement of PSA in Serum and Plasma by Nanotechnology
Hide Description Blood will be collected to measure PSA in serum and plasma by nanotechnology at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.
Time Frame At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.
Arm/Group Title Arm I - Genistein Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Genistein: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Placebo: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Events assessed at the following timepoints for the study: at the start of treatment, at surgery or radiation, at clinic visits occurring 1-3 months post-surgery, or post-initiation of radiation therapy, or at 3 months for those not undergoing surgery or radiation, as well as at a 4 month telephone contact.
Adverse Event Reporting Description Adverse events were collected by patient reports
 
Arm/Group Title Arm I - Genistein Arm II - Placebo
Hide Arm/Group Description

Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Genistein: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Placebo: Given orally

Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer

All-Cause Mortality
Arm I - Genistein Arm II - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I - Genistein Arm II - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   0/4 (0.00%) 
Cardiac disorders     
Atrial Fibrillation  1  1/8 (12.50%)  0/4 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I - Genistein Arm II - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   1/4 (25.00%) 
Cardiac disorders     
Atrial Fibrillation  1  1/8 (12.50%)  0/4 (0.00%) 
Investigations     
INR Increased  1  1/8 (12.50%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in Extremity  1  0/8 (0.00%)  1/4 (25.00%) 
Nervous system disorders     
Dizziness  1  0/8 (0.00%)  1/4 (25.00%) 
Skin and subcutaneous tissue disorders     
Large pimple  1  0/8 (0.00%)  1/4 (25.00%) 
Surgical and medical procedures     
Emergency right inguinal repair  1  1/8 (12.50%)  0/4 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
The study was closed by an internal safety and data monitoring committee due to slow accrual of the study.
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: William Catalona, MD
Organization: Northwestern University
Phone: 312-695-1301
EMail: WCatalona@nm.org
Layout table for additonal information
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01126879     History of Changes
Other Study ID Numbers: NCI 09U2
NCI-2010-00941
STU00019487 ( Other Identifier: Northwestern University IRB )
P50CA090386 ( U.S. NIH Grant/Contract )
First Submitted: May 18, 2010
First Posted: May 20, 2010
Results First Submitted: May 1, 2019
Results First Posted: July 2, 2019
Last Update Posted: September 10, 2019