Clinical trial · Interventional
Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance
The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer
NCT00744549CI-TRIAL-00031679completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether antioxidants (vitamin E, selenium and lycopene)can change(reduce)prostate tumor size or blood flow to the prostate as determined by MRI imaging among men on Active Surveillance.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E | Dietary Supplement | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.
- interventionNames
- Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- B
- description
- This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.
- interventionNames
- Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E
- Drug: Placebo
Primary outcomes (1)
- measure
- To determine the impact of combination vitamin E, lycopene, and selenium on MRI detected prostate tumor size and/or tumor blood flow among me on active surveillance
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * MRI detectable prostate cancer * PSA less than 15 ng/ml * Gleason score \<= 7 * Prostate cancer staging T1c or T2a Exclusion Criteria: * Concurrent use of high-dose vitamins which include selenium, lycopene, vitamin D or vitamin E * Other malignancies diagnosed or requiring treatment within the past 5 years (except superficial bladder cancer or basal cell carcinoma) * Current use of Proscar or Avodart
References
Publications (0)
Data not yet available
No reference posted for this study.