Lycopene in Treating Patients With Metastatic Prostate Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 10, 2003
Last updated: November 13, 2009
Last verified: October 2004

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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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:

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

Study Start Date: January 2004
Detailed Description:



  • 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.


  • 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.


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


  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • Not specified


  • Bilirubin no greater than 1.5 mg/dL* NOTE: *Includes patients with liver involvement secondary to tumor


  • See Disease Characteristics
  • Creatinine no greater than 2 times upper limit of normal


  • See Disease Characteristics


  • No other malignancy within the past 5 years except basal cell skin cancer
  • No medical or psychiatric condition that would preclude study participation


Biologic therapy

  • More than 4 weeks since prior immunotherapy


  • 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


  • No concurrent radiotherapy, including radiotherapy for new bone disease


  • See Disease Characteristics


  • 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 identifier: NCT00068731

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 - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615-7828
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
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
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
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
Study Chair: Aminah Jatoi, MD Mayo Clinic
Investigator: Joanne M. Vanyo, MSN Allegheny Cancer Center at Allegheny General Hospital
  More Information

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

Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses processed this record on April 21, 2014