Recurrent Prostate CancerNCT01682941
Soy Isoflavones in Treating Patients With Recurrent Prostate Cancer or Rising Prostate-Specific Antigen
A study testing Arm I Soy Bread and Arm II Soy-Almond Bread in people with Recurrent Prostate Cancer and Stage IV Prostate Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer. Isoflavones are compounds found in soy food that may prevent cancer. PURPOSE: This randomized phase II trial is studying how well soy isoflavones work in treating patients with recurrent prostate cancer or rising prostate-specific… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Recurrent Prostate Cancer, Stage IV Prostate Cancer
- What is being tested?
- Arm I Soy Bread and Arm II Soy-Almond Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to 7 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have histologically confirmed prostate cancer.
- Have completed primary therapy (radical prostatectomy, external beam radiation, brachytherapy) for prostate cancer. "Watchful waiting" patients will also be eligible.
- Have either two consecutive rises in prostate specific antigen (PSA) or a series of at least four PSA's over two years where the PSA doubling time is at least 3 months following a nadir response to localized therapy. The minimum PSA for this study is 0.2 ng/dL.
- Not be receiving ongoing chemotherapy, radiation therapy or biological therapy for internal malignancy including prostate cancer.
- At time of entry, the clinical team expects that no additional interventions for prostate cancer therapy (hormonal, chemotherapy, radiotherapy, etc.) will be necessary over the next 5 months.
- Not be currently using Finasteride, androgens, or other PSA modifying hormonal agents. Utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted. The use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products).
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- Have kidney and liver enzymes within normal limits. Men with kidney and liver enzymes that are slightly elevated (< 1.5 times the upper normal limit), but have been stable for several months particularly those that are related to a known disorder (such as Gilberts syndrome, past history of alcohol, hepatitis, or a history of non-alcoholic steatohepatitis) will be permitted to participate after clinical evaluation by the study physician."
- Have no history of malabsorptive disorders or other metabolic disorders requiring special diet recommendations. Diabetics will be permitted to participate.
- Voluntarily agree to participate and a sign an informed consent document.
- Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study.
Who cannot join
- Have an active malignancy other than prostate cancer that requires therapy.
- Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes, osteoporosis and men who have been stable (> 6 months of thyroid stimulating hormone within normal limits) on thyroid replacement therapy.
- Have a known allergy to tree nuts, soy or wheat protein.
- Have a recent history of iron deficient anemia (possible accentuation by soy).
- Antibiotic use in the last 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Bioavailability of Isoflavones Delivered by Soy Almond Bread in Men With Recurring Prostate Cancer and Rising Prostate Specific Antigen
RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer. Isoflavones are compounds found in soy food that may prevent cancer.
PURPOSE: This randomized phase II trial is studying how well soy isoflavones work in treating patients with recurrent prostate cancer or rising prostate-specific antigen
Read the detailed description
OBJECTIVES:
- To precisely quantify the absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites in men consuming the two bread products to define relationships between dietary intake, isoflavone metabolism and the biological outcomes.
II. To describe the safety as well as incidence and severity of toxicity in men consuming the control soy bread or beta-glucosidase-enriched soy bread.
III. To see if consumption of beta-glucosidase-enriched soy bread compared to control soy bread has a greater effect on blood hormonal patterns and biomarkers that favor anti-prostate cancer activity.
IV. To see if beta-glucosidase-enriched soy bread compared to control soy bread improves hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor binding protein 3, lower androgens), reduce prostate specific antigen velocity, and lower circulating vascular endothelial growth factor concentrations.
OUTLINE: Patients are randomized to 1 of 2 treatment arms (closed to accrual as of 02/14/2011).
ARM I: Patients consume 2 slices of soy bread daily for 8 weeks.
ARM II: Patients consume 2 slices of soy almond bread daily for 8 weeks.
After a 2 week washout period, patients crossover to the alternate treatment arm.
- Being tested
- Arm I Soy Bread, Arm II Soy-Almond Bread
- Keywords
- soy, isoflavones, functional food, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I Soy BreadDietary supplement
Also called soy isoflavones, soy phytoestrogens
On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy bread. Afterwards 2 slices of soy bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126.
Arm II Soy-Almond BreadDietary supplement
Also called soy isoflavones, soy phytoestrogens
On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy-almond bread. Afterwards 2 slices of soy-almond bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126.
| Study group | Role | What they receive |
|---|---|---|
| Soy Bread Intervention | Active comparator | Arm I Soy Bread Receives: Dietary Supplement: Arm I Soy Bread |
| Soy -Almond Bread Intervention | Experimental | Arm II Soy-Almond Bread Receives: Dietary Supplement: Arm II Soy-Almond Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites
Quantification of absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites to define relationships between dietary intake, isoflavone metabolism and the biological outcomes
Measured: 0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose
Secondary outcomes (3)
Change in hormonal patterns after soy bread and soy-almond bread interventions
Comparison of hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor binding protein-3, lower androgens), prostate specific antigen velocity, and circulating vascular endothelial growth factor concentrations
Measured: Day 0, 56, 70, and126
Changes in hormonal patterns that favor anti-prostate cancer activity
Comparison of isoflavone metabolites on blood hormonal patterns and biomarkers that favor anti-prostate cancer activity.
Measured: Days 0, 28, 56, 70, 98, and 126
Severity of toxicity in participants after consumption of the control soy bread or beta-glucosidase-enriched soy almond bread
Safety (NIH criteria) and toxicity will be measured at day 0 (start of first intervention), day 56 (end of first intervention), day 70 (start of second intervention), and day 126 (end of second intervention)
Measured: Day 0 and Day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startOct 2009
- Primary completionJun 2015
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Prostate CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Yael Vodovotz, Ohio State University Comprehensive Cancer Center
- Investigators
- Yael Vodovotz, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682941
- Sponsor's protocol ID
- OSU-08027
- Other IDs
- NCI-2010-02387, R21CA125909
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2012
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Isoflavones Delivered by Soy Almond Bread in Men With Recurring Prostate Cancer and Rising Prostate Specific Antigen
- ClinicalTrials.gov ID
- NCT01682941
- Acronym / sponsor ID
- OSU-08027
- Keywords
- soy, isoflavones, functional food, prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer. Isoflavones are compounds found in soy food that may prevent cancer.
PURPOSE: This randomized phase II trial is studying how well soy isoflavones work in treating patients with recurrent prostate cancer or rising prostate-specific antigen
Detailed description
OBJECTIVES:
- To precisely quantify the absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites in men consuming the two bread products to define relationships between dietary intake, isoflavone metabolism and the biological outcomes.
II. To describe the safety as well as incidence and severity of toxicity in men consuming the control soy bread or beta-glucosidase-enriched soy bread.
III. To see if consumption of beta-glucosidase-enriched soy bread compared to control soy bread has a greater effect on blood hormonal patterns and biomarkers that favor anti-prostate cancer activity.
IV. To see if beta-glucosidase-enriched soy bread compared to control soy bread improves hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor binding protein 3, lower androgens), reduce prostate specific antigen velocity, and lower circulating vascular endothelial growth factor concentrations.
OUTLINE: Patients are randomized to 1 of 2 treatment arms (closed to accrual as of 02/14/2011).
ARM I: Patients consume 2 slices of soy bread daily for 8 weeks.
ARM II: Patients consume 2 slices of soy almond bread daily for 8 weeks.
After a 2 week washout period, patients crossover to the alternate treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy Bread Intervention | Active comparator | Dietary Supplement: Arm I Soy BreadArm I Soy Bread |
| Soy -Almond Bread Intervention | Experimental | Dietary Supplement: Arm II Soy-Almond BreadArm II Soy-Almond Bread |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Have histologically confirmed prostate cancer.
- Have completed primary therapy (radical prostatectomy, external beam radiation, brachytherapy) for prostate cancer. "Watchful waiting" patients will also be eligible.
- Have either two consecutive rises in prostate specific antigen (PSA) or a series of at least four PSA's over two years where the PSA doubling time is at least 3 months following a nadir response to localized therapy. The minimum PSA for this study is 0.2 ng/dL.
- Not be receiving ongoing chemotherapy, radiation therapy or biological therapy for internal malignancy including prostate cancer.
- At time of entry, the clinical team expects that no additional interventions for prostate cancer therapy (hormonal, chemotherapy, radiotherapy, etc.) will be necessary over the next 5 months.
Key exclusion criteria (5 listed)
- Have an active malignancy other than prostate cancer that requires therapy.
- Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes, osteoporosis and men who have been stable (> 6 months of thyroid stimulating hormone within normal limits) on thyroid replacement therapy.
- Have a known allergy to tree nuts, soy or wheat protein.
- Have a recent history of iron deficient anemia (possible accentuation by soy).
- Antibiotic use in the last 6 months.
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 |
|---|---|---|
| Arm I Soy BreadAlso: soy isoflavones, soy phytoestrogensOn day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy bread. Afterwards 2 slices of soy bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126. | Dietary supplement | Soy Bread Intervention |
| Arm II Soy-Almond BreadAlso: soy isoflavones, soy phytoestrogensOn day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy-almond bread. Afterwards 2 slices of soy-almond bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126. | Dietary supplement | Soy -Almond Bread Intervention |
Primary outcome
Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites
Time frame: 0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose
Quantification of absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites to define relationships between dietary intake, isoflavone metabolism and the biological outcomes
3 secondary outcomes
Change in hormonal patterns after soy bread and soy-almond bread interventions
Time frame: Day 0, 56, 70, and126
Changes in hormonal patterns that favor anti-prostate cancer activity
Time frame: Days 0, 28, 56, 70, 98, and 126
Severity of toxicity in participants after consumption of the control soy bread or beta-glucosidase-enriched soy almond bread
Time frame: Day 0 and Day 126
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- JameslineLink provided by the sponsor.
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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.
Yael Vodovotz principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm I Soy Bread and Arm II Soy-Almond Bread in people with Recurrent Prostate Cancer and Stage IV Prostate Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites (time frame: 0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose). 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 22 Nov 2023.