Clinical trial NCT00068731: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage IV prostate cancer
recurrent prostate cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-09-11
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: 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
timeFrame: Up to 4 months
Secondary outcomes:
measure: response duration
timeFrame: Up to 5 years
measure: time to the first consistent PSA increase
timeFrame: Up to 5 years
measure: disease regression
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCOP - Mayo Clinic Scottsdale Oncology Program
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Atlanta
country: United States
facility: CCOP - Atlanta Regional
state: Georgia
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: New Orleans
country: United States
facility: CCOP - Ochsner
state: Louisiana
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Cloud
country: United States
facility: Coborn Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Bismarck
country: United States
facility: Medcenter One Health System
state: North Dakota
city: Dayton
country: United States
facility: CCOP - Dayton
state: Ohio
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi, MD
role: STUDY_CHAIR
References:
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.