Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068731
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2003-09-10
Brief Title:
Lycopene in Treating Patients With Metastatic Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000327843 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02555 | REGISTRY | None | None |