Prostate CancerPhase 2NCT00078923
Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
A Phase 2 study testing soy isoflavones and neoadjuvant therapy in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the development of early cancer. Soy isoflavones may be effective in delaying the development of early prostate cancer. 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?
- soy isoflavones and neoadjuvant therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to May 2010
- Phase
- Phase 2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Stage T1c or T2
- Disease confined to the prostate gland
- Planning to undergo radical prostatectomy within the next 3-4 weeks
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- ALT and AST less than 2 times upper limit of normal (ULN)
- Alkaline phosphatase less than 2 times ULN
Renal
- Not specified
Other
- Fertile patients must use effective barrier contraception
- Medically cleared for surgery
- No concurrent thyroid disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biological therapy for prostate cancer
- No concurrent biological agents
Chemotherapy
- No prior chemotherapy for prostate cancer
- No concurrent chemotherapy
Endocrine therapy
- No prior hormonal therapy for prostate cancer
- No concurrent thyroid hormone replacement medication
- No concurrent hormonal therapy
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Other
- At least 3 months since prior high-dose nutritional supplements
- No concurrent regular use (more than once weekly) of soy products greater than 50 g of soy protein or 50 mg of soy isoflavone
- No concurrent high-dose nutritional supplements
- Standard-dose single multivitamin tablet (e.g., Centrum™) allowed
- No concurrent herbs
- No concurrent soy foods
- No other concurrent isoflavone supplements
- No other concurrent antineoplastic agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the development of early cancer. Soy isoflavones may be effective in delaying the development of early prostate cancer.
PURPOSE: This randomized phase II trial is studying different regimens of soy isoflavones to compare how well they work in treating patients who are undergoing radical prostatectomy for stage I or stage II prostate cancer (adenocarcinoma).
Read the detailed description
OBJECTIVES:
- Compare blood/prostate biomarkers of oxidative stress and prostate cancer risk in patients with stage I or II adenocarcinoma of the prostate treated with 3 different dose levels of soy isoflavones before radical prostatectomy.
- Compare prostatic tissue biomarkers of proliferation and apoptosis in patients treated with these regimens.
- Determine the potential response, in terms of tumor and prostatic intraepithelial neoplasia grade and volume, extraprostatic extension, and serum prostate-specific antigen level, in patients treated with soy isoflavones and in those treated with placebo.
- Determine the safety of soy isoflavone supplementation in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study. Patients are stratified according to tumor stage (T1c vs T2). Patients are randomized to 1 of 4 treatment arms.
- Arm I (control group): Patients receive oral placebo once daily.
- Arm II: Patients receive oral soy isoflavones and oral placebo once daily.
- Arm III: Patients receive a higher dose of oral soy isoflavones and oral placebo once daily.
- Arm IV: Patients receive a higher dose (higher than arm III) of oral soy isoflavones once daily.
In all arms, treatment continues for 2-6 weeks (depending on the time from study entry to planned surgery) in the absence of unacceptable toxicity. All patients then undergo radical prostatectomy.
Patients are followed at 1 week.
PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study within 12.5 months.
- Conditions
- Prostate Cancer
- Being tested
- soy isoflavones, neoadjuvant therapy, Placebo
- Keywords
- stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate
- 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 isoflavonesDietary supplement
neoadjuvant therapyProcedure or surgery
Prostatectomy or Brachytherapy
PlaceboOther
Arm I: 4 placebo capsules Arm II: 3 placebo capsules Arm III: 2 placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Arm I (control group): Patients receive 4 placebo capsules by mouth daily for three weeks. Receives: Procedure: neoadjuvant therapy; Other: Placebo |
| Soy isoflavones and placebo | Experimental | Arm II: Patients receive oral soy isoflavones (PTI G-2535) 150 mg genistein capsules + 3 placebo capsules by mouth daily for 3 weeks. Receives: Dietary Supplement: soy isoflavones; Procedure: neoadjuvant therapy; Other: Placebo |
| Soy Isoflavones/Placebo | Experimental | Arm III: Patients receive oral soy isoflavones (PTI G-2535) 300 mg genistein capsules + 2 placebo capsules by mouth daily for 3 weeks. Receives: Dietary Supplement: soy isoflavones; Procedure: neoadjuvant therapy; Other: Placebo |
| Soy Isoflavones | Experimental | Arm IV: Arm III: Patients receive oral soy isoflavones (PTI G-2535) 600 mg genistein capsules by mouth daily for 3 weeks. Receives: Dietary Supplement: soy isoflavones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative DNA damage as measured by 5-hydroxymethyluridine level
Measured: at 3 weeks
Lipid oxidation as measured by 8-isoprostane level
Measured: at 3 weeks
Secondary outcomes (4)
Tumor size, grade, and extension
Measured: at 3 weeks
Prostate-specific antigen and prostatic intraepithelial neoplasia grade
Measured: at 3 weeks
Biomarkers of cell growth, differentiation, and apoptosis
Measured: at 3 weeks
Toxicity as measured by number and grade of adverse events
Measured: at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2004 (estimated)
- Study startNov 2001
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Omer Kucuk, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078923
- Sponsor's protocol ID
- CDR0000353197
- Other IDs
- P30CA022453, WSU-C-2418
- Status last verified
- Mar 2014
- First submitted
- 8 Mar 2004
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00078923
- Acronym / sponsor ID
- CDR0000353197
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2001
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Mar 2004 (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: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the development of early cancer. Soy isoflavones may be effective in delaying the development of early prostate cancer.
PURPOSE: This randomized phase II trial is studying different regimens of soy isoflavones to compare how well they work in treating patients who are undergoing radical prostatectomy for stage I or stage II prostate cancer (adenocarcinoma).
Detailed description
OBJECTIVES:
- Compare blood/prostate biomarkers of oxidative stress and prostate cancer risk in patients with stage I or II adenocarcinoma of the prostate treated with 3 different dose levels of soy isoflavones before radical prostatectomy.
- Compare prostatic tissue biomarkers of proliferation and apoptosis in patients treated with these regimens.
- Determine the potential response, in terms of tumor and prostatic intraepithelial neoplasia grade and volume, extraprostatic extension, and serum prostate-specific antigen level, in patients treated with soy isoflavones and in those treated with placebo.
- Determine the safety of soy isoflavone supplementation in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study. Patients are stratified according to tumor stage (T1c vs T2). Patients are randomized to 1 of 4 treatment arms.
- Arm I (control group): Patients receive oral placebo once daily.
- Arm II: Patients receive oral soy isoflavones and oral placebo once daily.
- Arm III: Patients receive a higher dose of oral soy isoflavones and oral placebo once daily.
- Arm IV: Patients receive a higher dose (higher than arm III) of oral soy isoflavones once daily.
In all arms, treatment continues for 2-6 weeks (depending on the time from study entry to planned surgery) in the absence of unacceptable toxicity. All patients then undergo radical prostatectomy.
Patients are followed at 1 week.
PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study within 12.5 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Procedure: neoadjuvant therapy, Other: PlaceboArm I (control group): Patients receive 4 placebo capsules by mouth daily for three weeks. |
| Soy isoflavones and placebo | Experimental | Dietary Supplement: soy isoflavones, Procedure: neoadjuvant therapy, Other: PlaceboArm II: Patients receive oral soy isoflavones (PTI G-2535) 150 mg genistein capsules + 3 placebo capsules by mouth daily for 3 weeks. |
| Soy Isoflavones/Placebo | Experimental | Dietary Supplement: soy isoflavones, Procedure: neoadjuvant therapy, Other: PlaceboArm III: Patients receive oral soy isoflavones (PTI G-2535) 300 mg genistein capsules + 2 placebo capsules by mouth daily for 3 weeks. |
| Soy Isoflavones | Experimental | Dietary Supplement: soy isoflavonesArm IV: Arm III: Patients receive oral soy isoflavones (PTI G-2535) 600 mg genistein capsules by mouth daily for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 isoflavones | Dietary supplement | Soy Isoflavones, Soy Isoflavones/Placebo, Soy isoflavones and placebo |
| neoadjuvant therapyProstatectomy or Brachytherapy | Procedure or surgery | Placebo, Soy Isoflavones/Placebo, Soy isoflavones and placebo |
| PlaceboArm I: 4 placebo capsules Arm II: 3 placebo capsules Arm III: 2 placebo capsules | Other | Placebo, Soy Isoflavones/Placebo, Soy isoflavones and placebo |
Primary outcome
Oxidative DNA damage as measured by 5-hydroxymethyluridine level
Time frame: at 3 weeks
Lipid oxidation as measured by 8-isoprostane level
Time frame: at 3 weeks
4 secondary outcomes
Tumor size, grade, and extension
Time frame: at 3 weeks
Prostate-specific antigen and prostatic intraepithelial neoplasia grade
Time frame: at 3 weeks
Biomarkers of cell growth, differentiation, and apoptosis
Time frame: at 3 weeks
Toxicity as measured by number and grade of adverse events
Time frame: at 3 weeks
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 5 Mar 2014.
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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.
Omer Kucuk, MD principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing soy isoflavones and neoadjuvant therapy in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute 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?
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 5 Mar 2014. 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.
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?
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?
Oxidative DNA damage as measured by 5-hydroxymethyluridine level (time frame: at 3 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 5 Mar 2014.