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Clinical Trials/NCT00068731
NCT00068731CompletedPhase 2

A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation

Alliance for Clinical Trials in Oncology36 sites in 1 country47 target enrollmentStarted: January 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
47
Locations
36
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • disease regression(Up to 5 years)
  • time to the first consistent PSA increase(Up to 5 years)
  • response duration(Up to 5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (36)

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