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.

Condition	Treatment or Intervention	Phase
stage IV prostate cancer recurrent prostate cancer	Drug: lycopene  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: nutritional supplementation	Phase II

Further Study Details: 

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.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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)

Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States
Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      Coborn Cancer Center, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
North Dakota
      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States
Ohio
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States
South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States

Study chairs or principal investigators

Aminah Jatoi, MD,  Study Chair,  Mayo Clinic Cancer Center   
Joanne M. Vanyo, MSN,  Allegheny General Hospital   

Study ID Numbers:  CDR0000327843; NCCTG-N0351; NCT00068731
Record last reviewed:  January 2005
Last Updated:  January 7, 2005
Record first received:  September 10, 2003
ClinicalTrials.gov Identifier:  NCT00068731
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08