Prostate Cancer
Conditions
Keywords
Fermented Soy
Brief summary
The purpose of this study is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with localized prostate cancer prior to radical prostatectomy.
Detailed description
This is a parallel group, double-blind, randomized clinical trial with two arms. The primary aim is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with prostate cancer. This study has 1 primary aim and 3 (1a thru 1c) sub aims. Aim 1 is to assess the effect of Fermented Soy (QC) on PSA (prostate specific antigen) In parallel, in Aims 1a-1c will assess tumor-specific effects of QC: Aim 1a: Identifying the anti-tumor effects of QC. This will be done by culturing multiple human cancer cell lines with QC at a range of concentrations, followed by readouts at different time points, of tumor cell apoptosis, proliferation, and senescence. Aim 1b: Identify a hierarchy of tumors that are responsive to QC. From the data in aim one an attempt will be made to identify a hierarchy of anti-tumor effects. Aim 1c: Investigate the signaling pathways in tumor cells that are modified by QC. To do this, full genomic profiling will be conducted for breast and prostate tumor cell lines, and will be done in conjunction with analysis of the relevant signaling pathways, and will include P53 and P21 activation pathways.
Interventions
DRUGFermented Soy
Two 12.5g packets/day) (\ 1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
OTHERPlacebo
A placebo compliment to the active intervention with identical packaging and labeling will be used.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically verified Prostate Cancer (at any stage) * Scheduled to be treated by radical prostatectomy within the next 4-10 weeks * Understanding and willingness to provide consent
Exclusion criteria
* Previous (within 6 months of enrollment) or concurrent hormonal therapy or chemotherapy; specifically, treatment with 5-alpha reductase inhibitors (finasteride and dutasteride) * History of hormone dependent malignancies * Concomitant thyroid disease or currently taking thyroid hormone replacement medication * Current high-dose soy consumption, micronutrient, or herbal supplements, on soy or vegetarian nutrition, or any other extreme dietary habits * Current or past history of any liver or pancreas disease * History of allergy or hypersensitivity to soy-containing products * Malabsorption conditions that might interfere with absorption of the investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate-specific Antigen (PSA) | Greater than or equal to 4 weeks (up to 10 weeks) | The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. The PSA range of scores and interpretation are as follows: Normal PSA Levels: 0 - 4 ng/mL, Slightly Elevated PSA: 4 - 10 ng/mL, Moderately Elevated PSA: 10 - 20 ng/mL, Highly Elevated PSA: 20+ ng/mL. Interpretation of these scores is also based on the age of the inidividual. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gleason Score | Greater than or equal to 4 weeks (up to 10 weeks) | Pathological investigation of the removed prostate gland will include the assessment of biopsy-proven, index prostate cancer lesion will lead to the analysis of any modulation of PCa grade (Gleason score) compared to preoperative biopsies. The Gleason Score is interpreted as follows: 3+4 (Prognosis = Good), 4+3 (Prognosis = Likely to Spread), 8 - 10 (Prognosis = Likely to Spread Rapidly). |
| PCa Tissue Telomeric DNA Length | Greater than or equal to 4 weeks (up to 10 weeks) | Analysis of telomere length in research samples of human peripheral blood mononuclear cells reveals that telomere length decreases with increased replication of cells, reflecting the replicative history of those cells. |
| Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change | Baseline to final visit (up to 10 weeks) | Post surgical/post intervention CAPRA score will be used for comparison with baseline (screening) value. The CAPRA score can range from 0 to 10 where: a score of 0 to 2 indicates low-risk, 3 to 5 indicates intermediate-risk, and 6 to 10 indicates high-risk. |
| Cell Cycle Progression Score | Greater than or equal to 4 weeks (up to 10 weeks) | Assessment of prostate cancer mRNA can be determined from PCa tissue. Cell cycle progression score assessment of PCa mRNA is a novel RNA expression-based assay that directly measures tumor cell growth characteristics in order to stratify patients with localized PCa according to disease aggressiveness. |
| Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©) | Greater than or equal to 4 weeks (up to 10 weeks) | Quality of life assessment for men with PCa will be assessed with the Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©). The FACT-P contains 39 items that use a 0-4 rating scale. The highest possible score is 156 (lowest possible score = 0). The total score is an indication of overall quality of life where the higher scores indicate better quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Daily Fermented Soy (two 12.5g packets/day) (\
1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Fermented Soy: Two 12.5g packets/day) (\
1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks. | 10 |
| Placebo Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used. | 9 |
| Total | 19 |
Baseline characteristics
| Characteristic | Intervention | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 6.9 | 62.9 years STANDARD_DEVIATION 6.4 | 61.7 years STANDARD_DEVIATION 6.6 |
| CAPRA Score 0-5: Low/Intermediate risk | 5 Participants | 5 Participants | 10 Participants |
| CAPRA Score 6-10: High risk | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 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 | 8 Participants | 7 Participants | 15 Participants |
| Region of Enrollment United States | 10 participants | 9 participants | 19 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 3 / 10 | 1 / 9 |
| serious Total, serious adverse events | 1 / 10 | 0 / 9 |
Outcome results
Primary
Prostate-specific Antigen (PSA)
The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. The PSA range of scores and interpretation are as follows: Normal PSA Levels: 0 - 4 ng/mL, Slightly Elevated PSA: 4 - 10 ng/mL, Moderately Elevated PSA: 10 - 20 ng/mL, Highly Elevated PSA: 20+ ng/mL. Interpretation of these scores is also based on the age of the inidividual.
Time frame: Greater than or equal to 4 weeks (up to 10 weeks)
Population: Intention to treat analysis population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Prostate-specific Antigen (PSA) | Baseline | 8.97 ng/mL | Standard Error 1.1 |
| Intervention | Prostate-specific Antigen (PSA) | Up to 10 Weeks | 8.11 ng/mL | Standard Error 1.12 |
| Placebo | Prostate-specific Antigen (PSA) | Baseline | 8.66 ng/mL | Standard Error 1.16 |
| Placebo | Prostate-specific Antigen (PSA) | Up to 10 Weeks | 8.92 ng/mL | Standard Error 1.21 |
p-value: 0.76Mixed Models Analysis
Secondary
Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change
Post surgical/post intervention CAPRA score will be used for comparison with baseline (screening) value. The CAPRA score can range from 0 to 10 where: a score of 0 to 2 indicates low-risk, 3 to 5 indicates intermediate-risk, and 6 to 10 indicates high-risk.
Time frame: Baseline to final visit (up to 10 weeks)
Population: Per protocol change in scores from baseline in those with complete data at baseline and end of study/treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change | -1.3 units on a scale | Standard Deviation 0.9 |
| Placebo | Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change | -1.4 units on a scale | Standard Deviation 1.3 |
Secondary
Cell Cycle Progression Score
Assessment of prostate cancer mRNA can be determined from PCa tissue. Cell cycle progression score assessment of PCa mRNA is a novel RNA expression-based assay that directly measures tumor cell growth characteristics in order to stratify patients with localized PCa according to disease aggressiveness.
Time frame: Greater than or equal to 4 weeks (up to 10 weeks)
Population: These data were not collected due to early termination of the study.
Secondary
Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©)
Quality of life assessment for men with PCa will be assessed with the Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©). The FACT-P contains 39 items that use a 0-4 rating scale. The highest possible score is 156 (lowest possible score = 0). The total score is an indication of overall quality of life where the higher scores indicate better quality of life.
Time frame: Greater than or equal to 4 weeks (up to 10 weeks)
Population: Presented are data for all participants with complete data.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©) | Baseline | 121.50 units on a scale |
| Intervention | Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©) | End of Study (up to 10 weeks) | 126.00 units on a scale |
| Placebo | Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©) | Baseline | 128.44 units on a scale |
| Placebo | Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©) | End of Study (up to 10 weeks) | 123.25 units on a scale |
Secondary
Gleason Score
Pathological investigation of the removed prostate gland will include the assessment of biopsy-proven, index prostate cancer lesion will lead to the analysis of any modulation of PCa grade (Gleason score) compared to preoperative biopsies. The Gleason Score is interpreted as follows: 3+4 (Prognosis = Good), 4+3 (Prognosis = Likely to Spread), 8 - 10 (Prognosis = Likely to Spread Rapidly).
Time frame: Greater than or equal to 4 weeks (up to 10 weeks)
Population: Participants that were available for assessment at the end of treatment/study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Gleason Score | 3+4 (Prognosis = Good) | 7 Participants |
| Intervention | Gleason Score | 4+3 (Prognosis = Likely to Spread) | 0 Participants |
| Intervention | Gleason Score | 8 - 10 (Prognosis = Likely to Spread Rapidly) | 1 Participants |
| Placebo | Gleason Score | 3+4 (Prognosis = Good) | 5 Participants |
| Placebo | Gleason Score | 4+3 (Prognosis = Likely to Spread) | 2 Participants |
| Placebo | Gleason Score | 8 - 10 (Prognosis = Likely to Spread Rapidly) | 1 Participants |
Secondary
PCa Tissue Telomeric DNA Length
Analysis of telomere length in research samples of human peripheral blood mononuclear cells reveals that telomere length decreases with increased replication of cells, reflecting the replicative history of those cells.
Time frame: Greater than or equal to 4 weeks (up to 10 weeks)
Population: These data were not collected due to early termination of the study.