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Lycopene in Treating Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lycopene
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • CCOP - Mayo Clinic Scottsdale Oncology Program
  • Mayo Clinic - Jacksonville
  • CCOP - Atlanta Regional
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology
  • CCOP - Wichita
  • CCOP - Ochsner
  • CCOP - Duluth
  • Mayo Clinic Cancer Center
  • Coborn Cancer Center
  • CCOP - Metro-Minnesota
  • Medcenter One Health System
  • CCOP - Dayton
  • CCOP - Upstate Carolina
  • CCOP - Sioux Community Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lycopene

Arm Description

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.

Outcomes

Primary Outcome Measures

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 Outcome Measures

response duration
time to the first consistent PSA increase
disease regression

Full Information

First Posted
September 10, 2003
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00068731
Brief Title
Lycopene in Treating Patients With Metastatic Prostate Cancer
Official Title
A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lycopene
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
lycopene
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
response duration
Time Frame
Up to 5 years
Title
time to the first consistent PSA increase
Time Frame
Up to 5 years
Title
disease regression
Time Frame
Up to 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aminah Jatoi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Mayo Clinic Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
CCOP - Atlanta Regional
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1701
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Siouxland Hematology-Oncology
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Coborn Cancer Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Medcenter One Health System
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501-5505
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17320666
Citation
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.
Results Reference
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Lycopene in Treating Patients With Metastatic Prostate Cancer

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