Clinical trial · Interventional
Selenium in Treating Patients With Prostate Cancer
Phase II Chemoprevention Trial of Selenium and Prostate Cancer (Watchful Waiting With Selenium Trial)
NCT00752739CI-TRIAL-00007832completedPhase 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)
RATIONALE: Selenium may prevent or slow the growth of prostate cancer. PURPOSE: This randomized phase II trial is studying how well selenium works in treating patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| selenium | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Arm I
- description
- Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Dietary Supplement: selenium
- type
- EXPERIMENTAL
- label
- Arm III
- description
- Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 85 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Biopsy-proven adenocarcinoma of the prostate within the past 48 months * Prostate-specific antigen \< 50 ng/mL * Gleason score \< 8 * Currently undergoing "watchful waiting" for prostate cancer * No metastatic disease PATIENT CHARACTERISTICS: * Life expectancy ≥ 3 years * AST and ALT ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 1.5 times ULN * Bilirubin ≤ 1.5 times ULN * Creatinine ≤ 1.5 times ULN * No other malignancy within the past 5 years, except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: * No prior hormone therapy, radiotherapy, chemotherapy, or surgery for prostate cancer * At least 90 days since prior and no concurrent selenium (as a dietary supplement or as part of a multivitamin) exceeding 50 mcg/day
References
Publications (0)
Data not yet available
No reference posted for this study.