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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
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000327843

NCT ID:

NCT00068731

Start Date:

January 2004

Completion Date:

Related Keywords:

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

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - DaytonKettering, Ohio  45429
Medcenter One Health SystemBismarck, North Dakota  58501
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259