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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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



- 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

- 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.

Inclusion Criteria


- 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)

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

January 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
CCOP - Dayton Kettering, Ohio  45429
Medcenter One Health System Bismarck, North Dakota  58501
Coborn Cancer Center Saint Cloud, Minnesota  56303
CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale, Arizona  85259