Lycopene in Treating Patients With Metastatic Prostate Cancer

NCT00068731 | Completed Phase 2 DMC

• 3 other identifiers: NCCTG-N0351NCI-2012-02555CDR0000327843
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 18

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.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• response duration

  Up to 5 years

• time to the first consistent PSA increase

  Up to 5 years

• disease regression

  Up to 5 years

Study Arms (1)

lycopene

EXPERIMENTAL

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.

Dietary Supplement: lycopene

Interventions

lycopene DIETARY_SUPPLEMENT

lycopene

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (18)

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615-7828, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501-5505, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Related 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 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.

  PMID: 17320666 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Aminah Jatoi, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: January 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: October 1, 2009
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (18)