Clinical trial · Interventional
Lycopene in Treating Patients With Metastatic Prostate Cancer
A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation
NCT00068731CI-TRIAL-00023022completedPhase 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: Lycopene, a substance found in tomatoes, may lower prostate-specific antigen (PSA) levels and slow or prevent the development of prostate cancer. PURPOSE: Phase II trial to study the effectiveness of lycopene in treating patients who have asymptomatic metastatic prostate cancer and a rising PSA level.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lycopene | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lycopene
- description
- Patients receive oral lycopene twice daily on days 1-28. Courses repeat every 28 days for at least 4 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
- interventionNames
- Dietary Supplement: lycopene
Primary outcomes (1)
- measure
- percentage of patients with asymptomatic androgen-independent metastatic prostate cancer and an elevated prostate-specific antigen (PSA) level who sustain a decline in PSA after 4 months of treatment with lycopene
- timeFrame
- Up to 4 months
Secondary outcomes (3)
- measure
- response duration
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of androgen-independent prostate cancer * Asymptomatic metastatic disease * Unlikely to become symptomatic within the next 4 months * No bone pain, shortness of breath, fatigue, or urinary symptoms directly attributable to prostate cancer * Radiologic, physically palpable, and/or biochemical evidence of tumor progression after prior orchiectomy OR during treatment with a luteinizing hormone-releasing hormone (LHRH) agonist OR after initiation of another hormonal agent * Sustained prostate-specific antigen (PSA) elevation, defined by the following: * PSA greater than 5 ng/mL * At least 2 consecutive increases in PSA at least 1 week apart * Sustained increase in PSA at least 4 weeks after discontinuation of prior flutamide (or other antiandrogen therapy) or megestrol AND at least 6 weeks after discontinuation of prior bicalutamide * No known CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Not specified Hepatic * Bilirubin no greater than 1.5 mg/dL\* NOTE: \*Includes patients with liver involvement secondary to tumor Renal * See Disease Characteristics * Creatinine no greater than 2 times upper limit of normal Pulmonary * See Disease Characteristics Other * No other malignancy within the past 5 years except basal cell skin cancer * No medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy Chemotherapy * More than 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy * See Disease Characteristics * More than 4 weeks since prior hormonal therapy (other than an LHRH agonist) * No concurrent corticosteroids * No concurrent progestational agents * No concurrent new hormonal therapy Radiotherapy * No concurrent radiotherapy, including radiotherapy for new bone disease Surgery * See Disease Characteristics Other * More than 4 weeks since other prior anticancer therapy * No other concurrent investigational anticancer agents * No other concurrent alternative medicine therapies (e.g., saw palmetto or PC-SPES)
References
Publications (1)
- RESULTJatoi A, Burch P, Hillman D, Vanyo JM, Dakhil S, Nikcevich D, Rowland K, Morton R, Flynn PJ, Young C, Tan W; North Central Cancer Treatment Group. A tomato-based, lycopene-containing intervention for androgen-independent prostate cancer: results of a Phase II study from the North Central Cancer Treatment Group. Urology. 2007 Feb;69(2):289-94. doi: 10.1016/j.urology.2006.10.019. PMID 17320666