Prostate CancerPhase 3NCT03532308
Nutrition and Prostate Cancer
A Phase 3 study testing Fermented Soy in people with Prostate Cancer, run by Yale University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Fermented Soy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Nov 2018to 14 Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Yale University
New Haven, Connecticut, 06520
Yale New Haven Health- Lawrence + Memorial Hospital
New London, Connecticut, 06320
South County Hospital
Wakefield, Rhode Island, 02879
About this study
Official title: Assessing the Clinical Response of Prostate Cancer to a Fermented Soy Extract
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Fermented Soy, Placebo
- Keywords
- Fermented Soy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented SoyDrug
Also called Q-CAN Plus
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.
PlaceboOther
A placebo compliment to the active intervention with identical packaging and labeling will be used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fermented Soy |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Greater than or equal to 4 weeks (up to 10 weeks)
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Greater than or equal to 4 weeks (up to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start21 Nov 2018
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
Why it stopped: Unable to meet recruitment goals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532308
- Sponsor's protocol ID
- 2000020868
- Status last verified
- May 2021
- First submitted
- 9 May 2018
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical Response of Prostate Cancer to a Fermented Soy Extract
- ClinicalTrials.gov ID
- NCT03532308
- Acronym / sponsor ID
- 2000020868
- Conditions
- Prostate Cancer
- Keywords
- Fermented Soy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet recruitment goals.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Posted 6 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Fermented SoyDaily 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 | Other: PlaceboDaily (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented SoyAlso: Q-CAN PlusTwo 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. | Drug | Intervention |
| PlaceboA placebo compliment to the active intervention with identical packaging and labeling will be used. | Other | Placebo |
Primary outcome
Prostate-specific Antigen (PSA)
Time frame: 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.
5 secondary outcomes
Gleason Score
Time frame: Greater than or equal to 4 weeks (up to 10 weeks)
PCa Tissue Telomeric DNA Length
Time frame: Greater than or equal to 4 weeks (up to 10 weeks)
Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change
Time frame: Baseline to final visit (up to 10 weeks)
Cell Cycle Progression Score
Time frame: Greater than or equal to 4 weeks (up to 10 weeks)
Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©)
Time frame: Greater than or equal to 4 weeks (up to 10 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fermented Soy in people with Prostate Cancer, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate-specific Antigen (PSA) (time frame: Greater than or equal to 4 weeks (up to 10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.