Lycopene in Treating Patients With Metastatic Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00068731
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

Study Timeline

• Study First Submitted: 2003-09-10
• Study First Submitted QC: 2003-09-10
• Study First Posted: 2003-09-11
• Study Start: 2004-01
• Primary Completion: 2007-02
• Study Completion: 2009-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	Up to 4 months

Secondary Outcome Measures

Name	Time	Method
disease regression	Up to 5 years
time to the first consistent PSA increase	Up to 5 years
response duration	Up to 5 years

Trial Locations

Locations (18)

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

Scroll for more (8 remaining)