Clinical trial · Interventional
Study of Antioxidants on Prostate Tumors in Men Undergoing Radical Prostatectomy for Prostate Cancer
A Randomized, Double-Blind Study of Combination Vitamin E, Selenium and Lycopene vs. Placebo in Men Undergoing Radical Prostatectomy for Prostate Cancer
NCT00844792CI-TRIAL-00030067completedPhase 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 see if an intervention of antioxidants(vitamin E, selenium and lycopene) can change (reduce) prostate tumor size and alter certain markers that can affect tumor growth and prostate cancer aggressiveness.
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
- 1
- description
- This group of men will be on active treatment (antioxidants)for 6-8 weeks prior to their radical prostatectomy.
- interventionNames
- Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- To determine the impact of combination Vitamin E, Selenium and Lycopene on prostate tumor size and to study certain markers in blood and prostate tissue which affect prostate tumor growth or shrinkage.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of a Gleason score \> or = to 7 adenocarcinoma of the prostate * At least 30% of one core involved * Radical prostatectomy planned * Willingness to discontinue use of supplements at least 4 weeks prior to study intervention (for subjects using vitamin E, selenium or lycopene at time of consent) * ability and willingness to consume study intervention for 6 - 8 weeks prior to radical prostatectomy. Exclusion Criteria: * Previous treatment for prostate cancer * Current use of finasteride or dutasteride
References
Publications (0)
Data not yet available
No reference posted for this study.