Trial Outcomes & Findings for Genistein in Treating Patients With Prostate Cancer (NCT NCT01126879)
NCT ID: NCT01126879
Last Updated: 2019-09-10
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Results posted on
2019-09-10
Participant Flow
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.
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.
Participant milestones
| Measure |
Arm I - Genistein
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
|
Arm II - Placebo
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 Study
STARTED
|
8
|
4
|
|
Overall Study
Started 3 Months of Genistein/Placebo
|
8
|
4
|
|
Overall Study
Prostatectomy or Radiation
|
8
|
4
|
|
Overall Study
Completed 3 Months Genistein/Placebo
|
4
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Arm I - Genistein
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
|
Arm II - Placebo
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 Study
Progressive Disease
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Genistein in Treating Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm I - Genistein
n=8 Participants
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
|
Arm II - Placebo
n=4 Participants
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
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgeryPopulation: Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, 1 and 12 months after surgeryPopulation: Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and at time of surgeryPopulation: Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgeryPopulation: Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.
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.
Outcome measures
Outcome data not reported
Adverse Events
Arm I - Genistein
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm II - Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I - Genistein
n=8 participants at risk
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
|
Arm II - Placebo
n=4 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
12.5%
1/8 • 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 events were collected by patient reports
|
0.00%
0/4 • 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 events were collected by patient reports
|
Other adverse events
| Measure |
Arm I - Genistein
n=8 participants at risk
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
|
Arm II - Placebo
n=4 participants at risk
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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/8 • 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 events were collected by patient reports
|
25.0%
1/4 • 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 events were collected by patient reports
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • 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 events were collected by patient reports
|
25.0%
1/4 • 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 events were collected by patient reports
|
|
Skin and subcutaneous tissue disorders
Large pimple
|
0.00%
0/8 • 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 events were collected by patient reports
|
25.0%
1/4 • 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 events were collected by patient reports
|
|
Surgical and medical procedures
Emergency right inguinal repair
|
12.5%
1/8 • 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 events were collected by patient reports
|
0.00%
0/4 • 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 events were collected by patient reports
|
|
Cardiac disorders
Atrial Fibrillation
|
12.5%
1/8 • 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 events were collected by patient reports
|
0.00%
0/4 • 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 events were collected by patient reports
|
|
Investigations
INR Increased
|
12.5%
1/8 • 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 events were collected by patient reports
|
0.00%
0/4 • 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 events were collected by patient reports
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place