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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00068731
Enrollment
47
Registered
2003-09-11
Start date
2004-01-31
Completion date
2009-10-31
Last updated
2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer, recurrent prostate cancer

Brief summary

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

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_SUPPLEMENTlycopene

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime 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 lycopeneUp to 4 months

Secondary

MeasureTime frame
response durationUp to 5 years
time to the first consistent PSA increaseUp to 5 years
disease regressionUp to 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026