Lycopene in Treating Patients With Metastatic Prostate Cancer

Overview

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.

Full Title of Study: “A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2007

Detailed Description

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.

Interventions

  • Dietary Supplement: lycopene

Arms, Groups and Cohorts

  • Experimental: lycopene
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: Up to 4 months

Secondary Measures

  • response duration
    • Time Frame: Up to 5 years
  • time to the first consistent PSA increase
    • Time Frame: Up to 5 years
  • disease regression
    • Time Frame: Up to 5 years

Participating in This Clinical Trial

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)

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alliance for Clinical Trials in Oncology
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Aminah Jatoi, MD, Study Chair, Mayo Clinic

Citations Reporting on Results

Jatoi 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.

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