Prostate NeoplasmPhase 3NCT00255125
Role of Soy Supplementation in Prostate Cancer Development
A Phase 3 study testing Soy Supplement in people with Prostate Neoplasm, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasm
- What is being tested?
- Soy Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Oct 2009
- 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 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Kansas City MO
Kansas City, Missouri, 64128
About this study
Official title: Role of Soy Isoflavones in Prostate Cancer Prevention
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.
Read the 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:
- To assess the effect of soy supplementation on endogenous hormone production levels and serum prostate specific antigens.
- To assess the impact of soy supplementation on estrogen receptor expression(ER).
- To determine the impact of soy isoflavones on cell cycle regulation and associated gene expression.
- Conditions
- Prostate Neoplasm
- Being tested
- Soy Supplement, Placebo
- Keywords
- Estrogen Receptor, Isoflavones, Prostate Neoplasm, Soy Supplementation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy SupplementDrug
Also called Fla-vien
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).
PlaceboDrug
Also called No other name
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).
| Study group | Role | What they receive |
|---|---|---|
| Arm Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Arm Soy Supplement | Experimental | Soy Supplement Receives: Drug: Soy Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Secondary outcomes (2)
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.
Measured: Two weeks
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2009
- Study completionOct 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate NeoplasmStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Peter Vanveldhuizen, MD, Principal investigator, VA Medical Center, Kansas City MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255125
- Sponsor's protocol ID
- CLIN-006-05S
- Status last verified
- Jun 2019
- First submitted
- 15 Nov 2005
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hamilton-Reeves JM, Banerjee S, Banerjee SK, Holzbeierlein JM, Thrasher JB, Kambhampati S, Keighley J, Van Veldhuizen P. Short-term soy isoflavone intervention in patients with localized prostate cancer: a randomized, double-blind, placebo-controlled trial. PLoS One. 2013 Jul 12;8(7):e68331. doi: 10.1371/journal.pone.0068331. Print 2013.
PubMed 23874588
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Soy Isoflavones in Prostate Cancer Prevention
- ClinicalTrials.gov ID
- NCT00255125
- Acronym / sponsor ID
- CLIN-006-05S
- Conditions
- Prostate Neoplasm
- Keywords
- Estrogen Receptor, Isoflavones, Prostate Neoplasm, Soy Supplementation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Sep 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 17 Nov 2005 (estimated)
- Results
- Posted 17 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the effect of soy supplementation on endogenous hormone production levels and serum prostate specific antigens.
- To assess the impact of soy supplementation on estrogen receptor expression(ER).
- To determine the impact of soy isoflavones on cell cycle regulation and associated gene expression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Arm Soy Supplement | Experimental | Drug: Soy SupplementSoy Supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Soy SupplementAlso: Fla-vienSoy 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). | Drug | Arm Soy Supplement |
| PlaceboAlso: No other namePlacebo 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). | Drug | Arm Placebo |
Primary outcome
Effect of Soy Isoflavones on Serum Testosterone Levels.
Time frame: 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.
2 secondary outcomes
Effect of Soy Isoflavones on Estrogen Receptor Status
Time frame: Two weeks
Molecular Effects of Soy Supplementation Compared to Placebo.
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23874588Hamilton-Reeves JM, Banerjee S, Banerjee SK, Holzbeierlein JM, Thrasher JB, Kambhampati S, Keighley J, Van Veldhuizen P. Short-term soy isoflavone intervention in patients with localized prostate cancer: a randomized, double-blind, placebo-controlled trial. PLoS One. 2013 Jul 12;8(7):e68331. doi: 10.1371/journal.pone.0068331. Print 2013.
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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.
Peter Vanveldhuizen, MD principal investigator
VA Medical Center, Kansas City MO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Soy Supplement in people with Prostate Neoplasm, run by VA Office of Research and Development 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 8 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 18 Jun 2019. 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. 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 17 Jun 2015). 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?
Effect of Soy Isoflavones on Serum Testosterone Levels. (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00255125, which also lists 1 linked publication.
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 18 Jun 2019.