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NCT00042731 · ClinicalTrials.gov registry record · NA
Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
A NA study of Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 79
- Enrollment target
- 5
- Study locations
NCT00042731: Completed NA study of Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00042731 is a NA study of Prostate Cancer that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 79 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00042731, a NA study of Prostate Cancer, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 79 participants
- Enrollment target
- 5
- Study locations
Study 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. 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.
Primary Outcome
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
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Multivitamin
- DIETARY_SUPPLEMENT Lycopene
- DIETARY_SUPPLEMENT Soy isoflavones
Study Locations (5)
Arizona
- CCOP - Western Regional, Arizona - Phoenix
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Georgia
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler - Savannah
North Dakota
- CCOP - MeritCare Hospital - Fargo
Texas
- CCOP - Scott and White Hospital - Temple
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2002-07 |
| Est. Completion | 2006-08 |
| Phase | NA |
What the finished NCT00042731 record still lists
NCT00042731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Multivitamin is the first listed.
NCT00042731 lists 5 locations in 5 states (Arizona, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT00042731 about?
NCT00042731 is a clinical study titled "Isoflavones & Lycopene in Localized Prostate Ca: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 compa...
What is the current status of trial NCT00042731?
This trial is currently completed. It is a NA study. The enrollment target is 79 participants. The study started on 2002-07. Estimated completion is 2006-08.
What conditions does trial NCT00042731 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00042731?
The interventions under investigation include: Multivitamin (DIETARY_SUPPLEMENT), Lycopene (DIETARY_SUPPLEMENT), Soy isoflavones (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00042731?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00042731 being conducted?
This trial has 5 study locations across Arizona, Florida, Georgia, North Dakota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00042731's enrollment target sits among peer trials
79 382nd of 735 higher than 353 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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