Prostate CancerNCT00042731
Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
A study testing Lycopene, Multivitamin and Soy isoflavones in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 5 sites in United States.
Trial summary
RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Lycopene, Multivitamin and Soy isoflavones
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2002to Aug 2006
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed localized prostate cancer
- Stage I or II
- Scheduled prostatectomy between 4-6 weeks after initial biopsy
PATIENT CHARACTERISTICS:
Age:
- 45 to 80
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- No known history of hepatic disease
Renal:
- No known history of renal disease
Other:
- No known history of thyroid disease
- Body mass index no greater than 32
- Omnivorous diet
- No known allergy to study supplements
- No evidence of prostatitis or urinary tract infection
- No other prior malignancy except nonmelanoma skin cancer
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent thyroid hormone replacement medications
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- At least 30 days since prior antibiotics
- At least 30 days since prior diet high in soy and/or lycopene products (e.g., greater than 40 mg soy/day and/or greater than 15 mg lycopene/day)
- No other concurrent nutritional supplements, including modular supplements with other carotenoids and isoflavones
- No prior or concurrent therapy for prostate cancer
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, 31405-6015
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
CCOP - Scott and White Hospital
Temple, Texas, 76508
About this study
Official title: A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer.
Read the detailed description
OBJECTIVES:
- Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients with localized prostate cancer.
- Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients.
- Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression (e.g., prostate-specific antigen levels) in these patients.
- Compare the effects of these nutritional supplements on changes in serum steroid hormones, estradiol, and free testosterone in these patients.
- Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial neoplasia. Patients are randomized to 1 of 7 treatment groups.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.
- Conditions
- Prostate Cancer
- Being tested
- Lycopene, Multivitamin, Soy isoflavones
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA 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.
LycopeneDietary supplement
Daily administration as outlined in treatment arm(s)
MultivitaminDietary supplement
Daily administration as outlined in treatment arm(s)
Soy isoflavonesDietary supplement
Daily administration as outlined in treatment arm(s)
| Study group | Role | What they receive |
|---|---|---|
| Oral isoflavones with multivitamin | Active comparator | Cohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. Receives: Dietary Supplement: Multivitamin; Dietary Supplement: Soy isoflavones |
| Oral lycopene with multivitamin | Active comparator | Cohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. Receives: Dietary Supplement: Lycopene; Dietary Supplement: Multivitamin |
| Multiple vitamin alone | Active comparator | Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. Receives: Dietary Supplement: Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrences of Treatment Effect on Biomarkers in Each Group
Effect of isoflavones and lycopene on endpoint biomarkers as measured by tissue cell proliferation, apoptosis, or programmed cell death at prostate cancer biopsy and surgical excision
Measured: 4 years
Secondary outcomes (4)
Occurrences of Plasma Level Changes for Each Group
Plasma levels of isoflavones and lycopene as measured by plasma analysis at baseline and post-study intervention
Measured: 4 years
Occurrence of Tissue Level Increases
Correlation of plasma and tissue levels of isoflavones and lycopene as measured by plasma and tissue analysis at baseline and post-study intervention
Measured: 4 years
Occurrences of Disease Progression for Each Group
Effect of isoflavones and lycopene on markers of disease progression as measured by prostate-specific antigen (PSA) levels at baseline and post-study intervention
Measured: 4 years
Occurrences of Hormonal Effect
Effect of isoflavones and lycopene on serum steroid hormones as measured by sex-hormone-binding globulin, estradiol, and free testosterone at baseline and post-study intervention
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 2002
- Primary completionAug 2006
- Study completionAug 2006
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.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nagi B. Kumar, PhD, RD, FADA, Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042731
- Sponsor's protocol ID
- MCC-13004
- Other IDs
- NCI-3811, NCI-P02-0216, 0105
- Status last verified
- Sep 2012
- First submitted
- 5 Aug 2002
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00042731
- Acronym / sponsor ID
- MCC-13004
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2002
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 27 Jan 2003 (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 rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer.
Detailed description
OBJECTIVES:
- Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients with localized prostate cancer.
- Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients.
- Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression (e.g., prostate-specific antigen levels) in these patients.
- Compare the effects of these nutritional supplements on changes in serum steroid hormones, estradiol, and free testosterone in these patients.
- Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial neoplasia. Patients are randomized to 1 of 7 treatment groups.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral isoflavones with multivitamin | Active comparator | Dietary Supplement: Multivitamin, Dietary Supplement: Soy isoflavonesCohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. |
| Oral lycopene with multivitamin | Active comparator | Dietary Supplement: Lycopene, Dietary Supplement: MultivitaminCohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. |
| Multiple vitamin alone | Active comparator | Dietary Supplement: MultivitaminPatients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. |
Who may qualify
- Ages
- 45 to 80 years
- 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 |
|---|---|---|
| LycopeneDaily administration as outlined in treatment arm(s) | Dietary supplement | Oral lycopene with multivitamin |
| MultivitaminDaily administration as outlined in treatment arm(s) | Dietary supplement | Multiple vitamin alone, Oral isoflavones with multivitamin, Oral lycopene with multivitamin |
| Soy isoflavonesDaily administration as outlined in treatment arm(s) | Dietary supplement | Oral isoflavones with multivitamin |
Primary outcome
Occurrences of Treatment Effect on Biomarkers in Each Group
Time frame: 4 years
Effect of isoflavones and lycopene on endpoint biomarkers as measured by tissue cell proliferation, apoptosis, or programmed cell death at prostate cancer biopsy and surgical excision
4 secondary outcomes
Occurrences of Plasma Level Changes for Each Group
Time frame: 4 years
Occurrence of Tissue Level Increases
Time frame: 4 years
Occurrences of Disease Progression for Each Group
Time frame: 4 years
Occurrences of Hormonal Effect
Time frame: 4 years
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 24 Sep 2012.
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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 B. Kumar, PhD, RD, FADA study chair
H. Lee Moffitt Cancer Center and Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycopene, Multivitamin and Soy isoflavones in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 5 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?
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 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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?
Occurrences of Treatment Effect on Biomarkers in Each Group (time frame: 4 years). 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 24 Sep 2012.