Lycopene in Treating Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068731
• Other study ID #: NCCTG-N0351
• Secondary ID: NCI-2012-02555CD
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2003
• Last updated: July 12, 2016
• Start date: January 2004
• Est. completion date: October 2009

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 2009
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• lycopene

Locations

Country	Name	City	State
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Medcenter One Health System	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Coborn Cancer Center	Saint Cloud	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Phas — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Up to 4 months	No
Secondary	response duration		Up to 5 years	No
Secondary	time to the first consistent PSA increase		Up to 5 years	No
Secondary	disease regression		Up to 5 years	No