Prostate Neoplasm
Conditions
Keywords
Estrogen Receptor, Isoflavones, Prostate Neoplasm, Soy Supplementation
Brief summary
This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be evaluated to determine the effects of the soy supplement on the prostate tissue.
Detailed description
This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patients will be randomized to either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. The specific objectives are: 1. To assess the effect of soy supplementation on endogenous hormone production levels and serum prostate specific antigens. 2. To assess the impact of soy supplementation on estrogen receptor expression(ER). 3. To determine the impact of soy isoflavones on cell cycle regulation and associated gene expression.
Interventions
DRUGSoy Supplement
Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).
DRUGPlacebo
Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven prostate cancer. * Surgical candidate for prostatectomy. * During study period, must agree not to take new supplements. * No concurrent chemotherapy, radiation or hormonal therapy. * No history of prior allergy to soy based products. * Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment. * Must be able to safely be on study supplements for period of at least two weeks prior to scheduled prostatectomy. * Must give written and informed consent in accordance with institutional and federal guidelines.
Exclusion criteria
During study period, must agree not to take new supplements. * No concurrent chemotherapy, radiation or hormonal therapy. * No history of prior allergy to soy based products. * Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment. * Must be able to safely be on study supplements for period of at least two weeks prior to scheduled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Soy Isoflavones on Serum Testosterone Levels. | Two weeks | Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Soy Isoflavones on Estrogen Receptor Status | Two weeks | Samples of the prostate cancer tissue (paraffin embedded) were sectioned and placed on a glass slide. Using immunohistochemistry and an estrogen receptor antibody, sections were stained and assess to determine the extent of estrogen receptor expression. Patients in the soy supplement arm's samples results were compared to placebo arm results. |
| Molecular Effects of Soy Supplementation Compared to Placebo. | One year | Using a tissue microarray targeting the cell cycle, selected fresh prostate cancer samples were evaluated in patients in the soy supplement arm compared to the placebo arm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm Soy Supplement Soy Supplement
Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice). | 42 |
| Arm Placebo Placebo
Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice). | 44 |
| Total | 86 |
Baseline characteristics
| Characteristic | Arm Soy Supplement | Arm Placebo | Total |
|---|---|---|---|
| Age, Continuous | 62 Years STANDARD_DEVIATION 12 | 62 Years STANDARD_DEVIATION 7 | 62 Years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 42 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 9 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 31 Participants | 69 Participants |
| Region of Enrollment United States | 42 Participants | 44 Participants | 86 Participants |
| Sex/Gender, Customized Male | 42 participants | 44 participants | 86 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 42 | 4 / 44 |
| serious Total, serious adverse events | 2 / 42 | 6 / 44 |
Outcome results
Primary
Effect of Soy Isoflavones on Serum Testosterone Levels.
Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo.
Time frame: Two weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm Soy Supplement | Effect of Soy Isoflavones on Serum Testosterone Levels. | 376 ng/ml |
| Arm Placebo | Effect of Soy Isoflavones on Serum Testosterone Levels. | 405 ng/ml |
Secondary
Effect of Soy Isoflavones on Estrogen Receptor Status
Samples of the prostate cancer tissue (paraffin embedded) were sectioned and placed on a glass slide. Using immunohistochemistry and an estrogen receptor antibody, sections were stained and assess to determine the extent of estrogen receptor expression. Patients in the soy supplement arm's samples results were compared to placebo arm results.
Time frame: Two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Soy Supplement | Effect of Soy Isoflavones on Estrogen Receptor Status | 130 pg/mL | Standard Deviation 58 |
| Arm Placebo | Effect of Soy Isoflavones on Estrogen Receptor Status | 131 pg/mL | Standard Deviation 56 |
Secondary
Molecular Effects of Soy Supplementation Compared to Placebo.
Using a tissue microarray targeting the cell cycle, selected fresh prostate cancer samples were evaluated in patients in the soy supplement arm compared to the placebo arm.
Time frame: One year
Population: Data and project staff no longer available to determine results.