Lycopene in Treating Patients With Metastatic Prostate Cancer

NCT ID: NCT00068731

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2009-10-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

lycopene

Intervention Type: DIETARY_SUPPLEMENT

Interventions

lycopene

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aminah Jatoi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

CCOP - Atlanta Regional

Atlanta, Georgia, United States

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Siouxland Hematology-Oncology

Sioux City, Iowa, United States

CCOP - Wichita

Wichita, Kansas, United States

CCOP - Ochsner

New Orleans, Louisiana, United States

CCOP - Duluth

Duluth, Minnesota, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Coborn Cancer Center

Saint Cloud, Minnesota, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Medcenter One Health System

Bismarck, North Dakota, United States

CCOP - Dayton

Dayton, Ohio, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 17320666 (View on PubMed)

Other Identifiers

NCI-2012-02555

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000327843

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-N0351

Identifier Type: -

Identifier Source: org_study_id