Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Lycopene in Treating Patients With Metastatic Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCCTG-N0351 N0351, NCT00068731

Objectives

Primary

1. 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

1. Determine the response duration of PSA decline in patients treated with this therapy.
2. Determine the time to the first consistent PSA increase in patients treated with this therapy.
3. Determine whether a decline in PSA coincides with evidence of disease regression on physical examination or radiographic assessment in patients treated with this therapy.
4. Determine the adverse event profile of this therapy in these patients.
5. Determine the factors that motivate prostate cancer patients to enroll in a nutritional-based therapy study.

Entry 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

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)

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

Expected Enrollment

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

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.

Jatoi A, Burch P, Hillman D, et al.: 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 69 (2): 289-94, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-284-4918
Joanne Vanyo, MSN, Protocol co-chair		Ph: 412-359-6542; 866-680-0004

Registry Information
Official Title		A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation
Trial Start Date		2004-01-30
Registered in ClinicalTrials.gov		NCT00068731
Date Submitted to PDQ		2003-08-04
Information Last Verified		2004-10-18
NCI Grant/Contract Number		U10-CA25224

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