Lycopene in Treating Patients With Metastatic Prostate Cancer - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068731

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: lycopene	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 2004

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.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068731

Locations

United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615-7828
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, North Dakota
Medcenter One Health System
Bismarck, North Dakota, United States, 58501-5505
United States, Ohio
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Aminah Jatoi, MD	Mayo Clinic
Investigator:	Joanne M. Vanyo, MSN	Allegheny Cancer Center at Allegheny General Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000327843, NCCTG-N0351
Study First Received:	September 10, 2003
Last Updated:	November 13, 2009
ClinicalTrials.gov Identifier:	NCT00068731 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:

Anticarcinogenic Agents
Radiation-Protective Agents
Antioxidants
Genital Neoplasms, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Lycopene
Physiological Effects of Drugs

Urogenital Neoplasms
Genital Diseases, Male
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009