Clinical trial · Interventional
Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
- 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: 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.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lycopene | Dietary Supplement | — | UNRESOLVED |
| Multivitamin | Dietary Supplement | — | UNRESOLVED |
| Soy isoflavones | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Oral isoflavones with multivitamin
- description
- 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.
- interventionNames
- Dietary Supplement: Multivitamin
- Dietary Supplement: Soy isoflavones
- type
- ACTIVE_COMPARATOR
- label
- Oral lycopene with multivitamin
- description
- 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.
- interventionNames
- Dietary Supplement: Lycopene
- Dietary Supplement: Multivitamin
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available