Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer

NCT00402285 | Completed Results

• 3 other identifiers: CDR0000505501UCSF-03553UCSF-H5664-22834-04A
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: The use of lycopene, a substance found in tomatoes, or omega-3 fatty acid nutritional supplements may keep cancer from growing in patients with prostate cancer. PURPOSE: This randomized clinical trial is studying lycopene to see how well it works compared to omega-3 fatty acids or a placebo in treating patients with stage I or stage II prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

• Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2

  Comparisons of the change in deltaCT were between the placebo and Lycopene arms for IGF-1 and IGF-1R and between the placebo and fish oil arms for COX-2. Data in the table are mean changes in qRTPCR gene expression (normalized to GUSb) for IGF1, Cox2, and IGF1R.

  baseline through 3 month

Study Arms (3)

lycopene supplement

ACTIVE COMPARATOR

Two 15mg lycopene capsules daily for 3 months.

Dietary Supplement: lycopene supplement

fish oil supplement

ACTIVE COMPARATOR

1g fish oil capsule daily for 3 months.

Dietary Supplement: fish oil supplement

placebo

PLACEBO COMPARATOR

placebos for lycopene and fish oil.

Other: Placebo

Interventions

lycopene supplement DIETARY_SUPPLEMENT

lycopene supplement

fish oil supplement DIETARY_SUPPLEMENT

fish oil supplement

Placebo OTHER

placebos for lycopene and fish oil.

placebo

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate meeting the following criteria: * Newly diagnosed disease * Small cell acinar type * Gleason score ≤ 6 with no pattern 4 or 5 histology * Gleason pattern 4 seen as a microfocus (\< 2 mm in length) allowed * Stage I-II (T1 or T2a) disease * Must have had an extended pattern biopsy (defined as 8+ cores) within the past 2 years * Patients meeting all of the eligibility criteria except for the aforementioned extended pattern biopsy within the past two years may enroll in the study if they have an extended pattern clinical biopsy scheduled no more than 6 weeks before beginning study treatment AND are willing to have an additional 4 biopsy cores * No more than 33% of biopsy cores positive * 33% or more of biopsy cores positive due to microfoci of adenocarcinoma allowed * No more than 50% of the length of a tumor core involved by carcinoma * Watchful waiting planned as primary treatment strategy * Must have 3 serum prostate-specific antigen (PSA) level readings taken ≥ 2 weeks apart over the past year * PSA ≤ 10.0 ng/mL * PSA \< 15 ng/mL in patients with benign prostatic hyperplasia or prostatitis allowed * PSA doubling time ≥ 3 months PATIENT CHARACTERISTICS: * Life expectancy ≥ 3 months * ECOG performance status 0-2 * No history of allergic reactions attributed to tomatoes, fish, soybean oil, gelatin capsules, or compounds of similar chemical or biologic composition to lycopene (carotenoids) or fish oil (omega-3 fatty acids) * No uncontrolled intercurrent illness including, but not limited to, the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situations that would limit study compliance PRIOR CONCURRENT THERAPY: * No prior or concurrent treatment for prostate cancer, including surgery, radiation, hormonal therapy (e.g., leuprolide acetate, bicalutamide, flutamide, goserelin, megestrol, nilutamide, diethylstilbestrol/estrogen), chemotherapy, PC-SPES, or investigational agents * More than 4 weeks since prior and no concurrent lycopene, fish oil (omega-3 fatty acids), or any other preparation intended to supplement levels of omega-3 unsaturated fatty acids * More than 4 weeks since prior and no concurrent finasteride, dutasteride, saw palmetto or any other herbal/nutritional preparation indicated to affect hormone levels * More than 1 month since prior nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and/or aspirin for \> 7 days duration * No concurrent NSAIDs, COX-2 inhibitors, or aspirin

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (2)

• Magbanua MJ, Roy R, Sosa EV, Weinberg V, Federman S, Mattie MD, Hughes-Fulford M, Simko J, Shinohara K, Haqq CM, Carroll PR, Chan JM. Gene expression and biological pathways in tissue of men with prostate cancer in a randomized clinical trial of lycopene and fish oil supplementation. PLoS One. 2011;6(9):e24004. doi: 10.1371/journal.pone.0024004. Epub 2011 Sep 1.

  PMID: 21912659 RESULT

• Magbanua MJ, Richman EL, Sosa EV, Jones LW, Simko J, Shinohara K, Haqq CM, Carroll PR, Chan JM. Physical activity and prostate gene expression in men with low-risk prostate cancer. Cancer Causes Control. 2014 Apr;25(4):515-23. doi: 10.1007/s10552-014-0354-x. Epub 2014 Feb 7.

  PMID: 24504435 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Peter Carroll, MD
• Organization: University of California, San Francisco

pcarroll@urology.ucsf.edu

415-353-7098

Study Officials

• Peter R. Carroll, MD

  University of California, San Francisco

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: April 1, 2003
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: January 1, 2016
• Results First Posted: May 16, 2013

Record last verified: 2015-12

Locations

US (1)