A Phase 2 interventional study of genistein and placebo in Adenocarcinoma of the Prostate, Recurrent Prostate Cancer and Stage I Prostate Cancer, sponsored by Northwestern University. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-10.
Sponsored by Northwestern University · Phase 2, Interventional, and Treatment
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer.
PRIMARY OBJECTIVES:
I. Determine whether genistein treatment will decrease the number of circulating prostate cells (CPCs) in the peripheral blood as measured by qRT-PCR for PSA performed on RNA extracted from peripheral blood mononuclear cells (PBMNCs).
SECONDARY OBJECTIVES:
I. Determine the natural history of circulating prostate cells (CPCs) in a cohort of subjects prior to and post radical prostatectomy.
II. Compare the measurement of PSA between three separate methods: in CPCs by qRT-PCR, in serum by the standard clinical chemistry assay (i.e., ELISA), and in plasma and serum by the nano-PSA assay.
III. Measure the effect of genistein on gene and protein expression in prostate tissue by qRT-PCR and immunohistochemistry, respectively, for the following genes and their respective protein products: HSP27, MMP-2, ALK-2, BASP1, and HCF2.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
ARM II: Patients receive oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
All patients undergo radical prostatectomy at least 2 weeks, but not more than 3 months following the start of therapy.
After completion of study treatment, patients are followed at 1, 6, and 12 months.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 12 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion
Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
Dietary Supplement: genistein · Procedure: therapeutic conventional surgery
Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
Other: placebo · Procedure: therapeutic conventional surgery
Given orally
Also known as: CI 75610, Genestein, genisteol, genisterin, prunetol, sophoricol
Given orally
Also known as: PLCB
Radical prostatectomy for treatment of prostate cancer
Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs
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
Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy
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
Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue
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
Measurement of PSA in Serum and Plasma by Nanotechnology
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
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.
| Milestone | Arm I - Genistein | Arm II - Placebo |
|---|---|---|
| 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 |
| Withdrew: Progressive disease | 3 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Physician decision | 1 | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I - Genistein | 0/8 (0%) | 1/8 (12.5%) | 2/8 (25%) |
| Arm II - Placebo | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Event | Arm I - Genistein | Arm II - Placebo |
|---|---|---|
| Atrial FibrillationCardiac disorders | 1/8 | 0/4 |
| Event | Arm I - Genistein | Arm II - Placebo |
|---|---|---|
| Pain in ExtremityMusculoskeletal and connective tissue disorders | 0/8 | 1/4 |
| DizzinessNervous system disorders | 0/8 | 1/4 |
| Large pimpleSkin and subcutaneous tissue disorders | 0/8 | 1/4 |
| Emergency right inguinal repairSurgical and medical procedures | 1/8 | 0/4 |
| Atrial FibrillationCardiac disorders | 1/8 | 0/4 |
| INR IncreasedInvestigations | 1/8 | 0/4 |
| Age, Categorical(Participants) | Arm I - Genistein | Arm II - Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 2 | 7 |
| >=65 years | 3 | 2 | 5 |
| Sex: Female, Male(Participants) | Arm I - Genistein | Arm II - Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 8 | 4 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Arm I - Genistein | Arm II - Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 8 | 3 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm I - Genistein | Arm II - Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 8 | 4 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Arm I - Genistein | Arm II - Placebo | Total |
|---|---|---|---|
| United States | 8 | 4 | 12 |
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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