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Unable to meet recruitment goals.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented Soy | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Greater than or equal to 4 weeks (up to 10 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States | ||
| Yale New Haven Health- Lawrence + Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants enrolled and randomized to a treatment arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to treat analysis population. | Posted | Least Squares Mean | Standard Error | ng/mL | Greater than or equal to 4 weeks (up to 10 weeks) |
|
Up to 10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unrelated hospitalization where participant experienced an Aortic Aneurysm and presented with Pneumonia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael S. Leapman, MD | Yale University School of Medicine | (203) 785-2815 | michael.leapman@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2019 | Feb 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 9, 2020 | Feb 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Placebo | Other | A placebo compliment to the active intervention with identical packaging and labeling will be used. |
|
| Greater than or equal to 4 weeks (up to 10 weeks) |
| 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. | Greater than or equal to 4 weeks (up to 10 weeks) |
| 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. | Baseline to final visit (up to 10 weeks) |
| 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. | Greater than or equal to 4 weeks (up to 10 weeks) |
| 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. | Greater than or equal to 4 weeks (up to 10 weeks) |
| New London |
| Connecticut |
| 06320 |
| United States |
| South County Hospital | Wakefield | Rhode Island | 02879 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CAPRA Score | The CAPRA score is a measure of prostate cancer risk that ranges from 0 - 10. A CAPRA score of: 0 to 2 indicates low-risk, 3 to 5 indicates intermediate-risk, 6 to 10 indicates high-risk. For the purposes of this study, the low-risk and intermediate-risk groups were combined as part of the randomization stratification. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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). | Participants that were available for assessment at the end of treatment/study. | Posted | Count of Participants | Participants | Greater than or equal to 4 weeks (up to 10 weeks) |
|
|
|
| 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. | These data were not collected due to early termination of the study. | Posted | Greater than or equal to 4 weeks (up to 10 weeks) |
|
|
| 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. | Per protocol change in scores from baseline in those with complete data at baseline and end of study/treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline to final visit (up to 10 weeks) |
|
|
|
| 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. | These data were not collected due to early termination of the study. | Posted | Greater than or equal to 4 weeks (up to 10 weeks) |
|
|
| 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. | Presented are data for all participants with complete data. | Posted | Mean | 95% Confidence Interval | units on a scale | Greater than or equal to 4 weeks (up to 10 weeks) |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 3 |
| 10 |
| EG001 | 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. | 0 | 9 | 0 | 9 | 1 | 9 |
|
| Aortic Aneurysm | Cardiac disorders | Non-systematic Assessment | Unrelated hospitalization where participant experienced an Aortic Aneurysm and presented with Pneumonia. |
|
| Nausea/Dizzyness | Nervous system disorders | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| 8 - 10 (Prognosis = Likely to Spread Rapidly) |
|
| End of Study (up to 10 weeks) |
|
|