Lycopene in Treating Patients With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine the 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. Secondary Determine the response duration of PSA decline in patients treated with this therapy. Determine the time to the first consistent PSA increase in patients treated with this therapy. Determine whether a decline in PSA coincides with evidence of disease regression on physical examination or radiographic assessment in patients treated with this therapy. Determine the adverse event profile of this therapy in these patients. Determine the factors that motivate prostate cancer patients to enroll in a nutritional-based therapy study. OUTLINE: This is a multicenter study. 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.

Official Title
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A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: lycopene


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lycopene<br>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. | Dietary Supplement: lycopene<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response duration |  | Up to 5 years | 
| time to the first consistent PSA increase |  | Up to 5 years | 
| disease regression |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV prostate cancer, recurrent prostate cancer