Prostate CancerPhase 2NCT01036321
Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness
A Phase 2 study testing Purified isoflavones and Methyl cellulose blend in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in United States.
Trial summary
The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo for a 3-6 week period to see if we can slow down the rate of prostate cancer growth. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Purified isoflavones and Methyl cellulose blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Dec 2009to 16 Apr 2018
- Phase
- Phase 2
- 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 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of localized prostate cancer (PCa), based on pathological assessment from biopsy specimens
- No prior or current therapy for PCa or history of cancer except non-melanoma skin cancer
- Scheduled for prostatectomy between 3- 6 weeks (+/-3 days) after start of study agent
- No known history of hepatic or renal disease (LFTs (SGOT/SGPT) > 5.0 x upper limit of normal as evidenced by impairment of baseline laboratory values, Actual creatinine clearance of >60 utilizing the Cockcroft-Gault formula (1976), which employs creatinine measurements and a patient's weight to predict the clearance. The constant is 1.23 for men.
- Omnivorous diet
- No evidence of prostatitis or urinary tract infection
Show all 14Show fewer
- Able and willing to give written informed consent
- Currently not using or willing to discontinue any nutritional supplements that contain soy or soy isoflavones
- Not allergic to study supplements
- Not on antibiotics
- Men who do not consume more than 3 - 4 oz. of soy or soy products per week
- Not taking steroid hormones or medications which have known impact on prostatic specific antigen (PSA)
- Health status cleared by primary MD or urologist
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Who cannot join
- Prior history of prostate cancer; Current or prior history of other malignancies (exceptions include nonmelanoma skin cancer or other cancer with no evidence of tumor recurrence five years after definitive treatment)
- History of renal or hepatic disease, including history of hepatitis B, C or delta as evidenced by impairment of baseline laboratory values
- Participation in any other investigational study or use of any other investigational agents within 30 days of study entry
- History of allergic reactions attributed to soy isoflavones or other compounds of similar chemical or biologic composition to Novasoy 400® or the inactive components present in the purified isoflavone and placebo capsules
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any psychological, familial, sociological or other concomitant condition that would not allow adequate compliance with the study protocol
- Only African American (a person having origins in any of the black racial groups of Africa) and Caucasian (a person having origins in any of the original people of Europe, Middle East, or North Africa) men, as defined by the NIH, will be included in this study. Since this is an investigation targeting men with PCa, women are not eligible for the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida & Shands Medical Center - Jacksonville
Jacksonville, Florida, 32209
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
James A. Haley VA Hospital
Tampa, Florida, 33612
About this study
Official title: Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness and Mechanism of Action Between African American and Caucasian Men
The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo for a 3-6 week period to see if we can slow down the rate of prostate cancer growth. A placebo is a pill or something that looks like the medicine that is being studied but has no active medicine in it. We also want to see if taking purified isoflavones is safe and if it reduces lower urinary tract symptoms. In addition, we want to study if purified isoflavones are able to slow the progression of prostate cancer, and the mechanism of action of purified isoflavones. If the safety and the effects of purified isoflavones on slowing down the progression of prostate cancer is shown in our study, this will also be a safe way of treating men who are at high risk of prostate cancer, so that we can prevent prostate cancer in the future.
Read the detailed description
Patients will need to take two (2) capsules daily, one with their breakfast and one with their dinner. On the day prior or the day that patients are coming in for their pre-operative surgery blood work, we ask that they take the second dose with lunch, if their appointment is in the afternoon.
At the start of the study and at the end of the study (3-6 weeks), patients will undergo interviews, complete questionnaires, and have lab tests to determine if this drug is effective to reduce progression of prostate cancer and is safe to use.
Patients will also receive a multivitamin/mineral supplement for the 3-6 weeks that they are on this study and will be required to take one (1) every day. It is required that patients not take any other vitamin/mineral or herbal preparation containing isoflavones and avoid eating or drinking soy products.
We anticipate that most patients will be scheduled for a prostatectomy 3-6 weeks (+/- 3 days) from start of study agent. In addition to their first visit, patients will be required to come in the day of the surgery for prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- Purified isoflavones, Methyl cellulose blend
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purified isoflavonesDrug
Also called Novasoy 400, Avicel PH105
Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily
Methyl cellulose blendDrug
Also called Avicel PH105
Placebo - Take 2 capsules daily
| Study group | Role | What they receive |
|---|---|---|
| Purified Isoflavones | Active comparator | Soy-based isoflavone concentrate with methyl cellulose blend filler. 40 mg daily. Receives: Drug: Purified isoflavones |
| Methyl cellulose blend | Placebo comparator | Placebo. Receives: Drug: Methyl cellulose blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Change in Percent Ki-67 From Baseline
Efficacy: Change in percent Ki-67 evaluated in prostate cancer (PCa) tissue specimens after 3-6 weeks of intervention with purified isoflavones (40 mg daily) vs. Placebo.
Measured: Baseline to post intervention - up to 6 weeks
Number of Toxicity Events by Final Attribution and Treatment Arm
Safety: Incidence of Adverse Events (AEs) occurring during intervention with either 20 mg purified isoflavones bid or placebo. Serious Adverse Event (SAEs) and other Adverse Event (AE) details are also reported in the Adverse Event sections.
Measured: Up to 6 weeks
Secondary outcomes (8)
Biomarkers of Disease Progression - Serum PSA
Median change from baseline to post intervention: Prostatic specific antigen (PSA). All Participants (ALL); Caucasian Men only (CM only); African American Men only (AAM only).
Measured: Up to 6 weeks
Change in Plasma Concentrations of Isoflavone
Plasma concentrations of isoflavone: Genistein from baseline to post intervention by study arm.
Measured: Up to 6 weeks
Biomarkers of Disease Progression - Estradiol
Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
Measured: Up to 6 weeks
Biomarkers of Disease Progression - Free Testosterone
Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
Measured: Up to 6 weeks
Biomarkers of Disease Progression - Insulin Like Growth Factor (IGF) Binding Protein -3
Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
Measured: Up to 6 weeks
Biomarkers of Disease Progression - IGF-1
Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
Measured: Up to 6 weeks
Biomarkers of Disease Progression - Sex Hormone-binding Globulin (SHBG)
Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
Measured: Up to 6 weeks
Biomarkers of Disease Progression - Total Testosterone
Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study start11 Dec 2009
- Primary completion26 Jun 2014
- Study completion16 Apr 2018
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 H. Lee Moffitt Cancer Center and Research InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Nagi Kumar, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036321
- Sponsor's protocol ID
- MCC-15835
- Other IDs
- IRB 107980, 1P20MD003375-01
- Status last verified
- Aug 2019
- First submitted
- 17 Dec 2009
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness and Mechanism of Action Between African American and Caucasian Men
- ClinicalTrials.gov ID
- NCT01036321
- Acronym / sponsor ID
- MCC-15835
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 11 Dec 2009 (actual)
- Primary completion
- 26 Jun 2014 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Posted 13 Aug 2015
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 our study is to recruit and treat 96 men diagnosed with prostate cancer and scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo for a 3-6 week period to see if we can slow down the rate of prostate cancer growth. A placebo is a pill or something that looks like the medicine that is being studied but has no active medicine in it. We also want to see if taking purified isoflavones is safe and if it reduces lower urinary tract symptoms. In addition, we want to study if purified isoflavones are able to slow the progression of prostate cancer, and the mechanism of action of purified isoflavones. If the safety and the effects of purified isoflavones on slowing down the progression of prostate cancer is shown in our study, this will also be a safe way of treating men who are at high risk of prostate cancer, so that we can prevent prostate cancer in the future.
Detailed description
Patients will need to take two (2) capsules daily, one with their breakfast and one with their dinner. On the day prior or the day that patients are coming in for their pre-operative surgery blood work, we ask that they take the second dose with lunch, if their appointment is in the afternoon.
At the start of the study and at the end of the study (3-6 weeks), patients will undergo interviews, complete questionnaires, and have lab tests to determine if this drug is effective to reduce progression of prostate cancer and is safe to use.
Patients will also receive a multivitamin/mineral supplement for the 3-6 weeks that they are on this study and will be required to take one (1) every day. It is required that patients not take any other vitamin/mineral or herbal preparation containing isoflavones and avoid eating or drinking soy products.
We anticipate that most patients will be scheduled for a prostatectomy 3-6 weeks (+/- 3 days) from start of study agent. In addition to their first visit, patients will be required to come in the day of the surgery for prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purified Isoflavones | Active comparator | Drug: Purified isoflavonesSoy-based isoflavone concentrate with methyl cellulose blend filler. 40 mg daily. |
| Methyl cellulose blend | Placebo comparator | Drug: Methyl cellulose blendPlacebo. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of localized prostate cancer (PCa), based on pathological assessment from biopsy specimens
- No prior or current therapy for PCa or history of cancer except non-melanoma skin cancer
- Scheduled for prostatectomy between 3- 6 weeks (+/-3 days) after start of study agent
- No known history of hepatic or renal disease (LFTs (SGOT/SGPT) > 5.0 x upper limit of normal as evidenced by impairment of baseline laboratory values, Actual creatinine clearance of >60 utilizing the Cockcroft-Gault formula (1976), which employs creatinine measurements and a patient's weight to predict the clearance. The constant is 1.23 for men.
- Omnivorous diet
Key exclusion criteria (6 listed)
- Prior history of prostate cancer; Current or prior history of other malignancies (exceptions include nonmelanoma skin cancer or other cancer with no evidence of tumor recurrence five years after definitive treatment)
- History of renal or hepatic disease, including history of hepatitis B, C or delta as evidenced by impairment of baseline laboratory values
- Participation in any other investigational study or use of any other investigational agents within 30 days of study entry
- History of allergic reactions attributed to soy isoflavones or other compounds of similar chemical or biologic composition to Novasoy 400® or the inactive components present in the purified isoflavone and placebo capsules
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any psychological, familial, sociological or other concomitant condition that would not allow adequate compliance with the study protocol
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 |
|---|---|---|
| Purified isoflavonesAlso: Novasoy 400, Avicel PH105Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily | Drug | Purified Isoflavones |
| Methyl cellulose blendAlso: Avicel PH105Placebo - Take 2 capsules daily | Drug | Methyl cellulose blend |
Primary outcome
Median Change in Percent Ki-67 From Baseline
Time frame: Baseline to post intervention - up to 6 weeks
Efficacy: Change in percent Ki-67 evaluated in prostate cancer (PCa) tissue specimens after 3-6 weeks of intervention with purified isoflavones (40 mg daily) vs. Placebo.
Number of Toxicity Events by Final Attribution and Treatment Arm
Time frame: Up to 6 weeks
Safety: Incidence of Adverse Events (AEs) occurring during intervention with either 20 mg purified isoflavones bid or placebo. Serious Adverse Event (SAEs) and other Adverse Event (AE) details are also reported in the Adverse Event sections.
8 secondary outcomes
Biomarkers of Disease Progression - Serum PSA
Time frame: Up to 6 weeks
Change in Plasma Concentrations of Isoflavone
Time frame: Up to 6 weeks
Biomarkers of Disease Progression - Estradiol
Time frame: Up to 6 weeks
Biomarkers of Disease Progression - Free Testosterone
Time frame: Up to 6 weeks
Biomarkers of Disease Progression - Insulin Like Growth Factor (IGF) Binding Protein -3
Time frame: Up to 6 weeks
Biomarkers of Disease Progression - IGF-1
Time frame: Up to 6 weeks
Biomarkers of Disease Progression - Sex Hormone-binding Globulin (SHBG)
Time frame: Up to 6 weeks
Biomarkers of Disease Progression - Total Testosterone
Time frame: Up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nagi Kumar, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Purified isoflavones and Methyl cellulose blend in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 14 inclusion and 6 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 6 Aug 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Aug 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?
Median Change in Percent Ki-67 From Baseline (time frame: Baseline to post intervention - up to 6 weeks). The study lists 2 primary outcomes in all. 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 6 Aug 2019.