Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00450749
First received: March 20, 2007
Last updated: April 23, 2014
Last verified: April 2013
  Purpose

This randomized phase II trial studies how well different doses of lycopene work in treating patients undergoing radical prostatectomy for prostate cancer. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from growing or coming back after surgery.


Condition Intervention Phase
Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage III Prostate Cancer
Other: placebo
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Drug: lycopene
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Placebo Controlled Trial of Preoperative Lycopene Supplementation in Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Concentration of Lycopene in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]
    Total tissue lycopene concentrations in radical prostatectomy specimens in participants receiving 6 weeks (± 1 week) of preoperative supplementation with 60 mg/day lycopene, 30 mg/day lycopene, or placebo. Concentration of lycopene in prostatic surgical tissue calculated using the high-performance liquid chromatography (HPLC) method.

  • Change in Serum Lycopene Concentration [ Time Frame: Baseline and at 4-7 weeks ] [ Designated as safety issue: No ]
    The differences in the mean of the 6 week (± 1 week) serum lycopene concentrations after adjusting for baseline serum lycopene concentrations calculated between the three arms, together with 95% confidence intervals.


Secondary Outcome Measures:
  • Ratio of Testosterone (T) to Dihydrotestosterone (DHT) in Serum [ Time Frame: Baseline and at 4-7 weeks ] [ Designated as safety issue: No ]
  • Ratio of T:DHT in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]
  • Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2 [ Time Frame: Baseline and at 4-7 weeks ] [ Designated as safety issue: No ]
  • Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]
  • Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3 [ Time Frame: At baseline and at 4-7 weeks ] [ Designated as safety issue: No ]
  • Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay [ Time Frame: At baseline and at 4-7 weeks ] [ Designated as safety issue: No ]
  • Expression of GST-pi in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]
  • Histological Characteristics of Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]
  • Modulation of Expression of Androgen-related Genes as Measured by Microarray in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I (placebo)
Patients receive placebo PO QD for 4-7 weeks, and then undergo radical prostatectomy.
Other: placebo
Given PO
Other Name: PLCB
Procedure: therapeutic conventional surgery
Undergo radical prostatectomy
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (low-dose lycopene)
Patients receive low-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
Procedure: therapeutic conventional surgery
Undergo radical prostatectomy
Other: laboratory biomarker analysis
Correlative studies
Drug: lycopene
Given PO
Other Names:
  • all-trans-Lycopene
  • Lyc-O-Mato
  • LYCO
  • psi,psi-Carotene
Experimental: Arm III (high-dose lycopene)
Patients receive high-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
Procedure: therapeutic conventional surgery
Undergo radical prostatectomy
Other: laboratory biomarker analysis
Correlative studies
Drug: lycopene
Given PO
Other Names:
  • all-trans-Lycopene
  • Lyc-O-Mato
  • LYCO
  • psi,psi-Carotene

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Criteria:

  • Creatinine normal
  • Biopsy-confirmed adenocarcinoma of the prostate
  • Localized disease
  • Planned radical prostatectomy
  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • WBC >= 3,000/mm^3
  • Platelet count >= 100,000/mm^3
  • Bilirubin normal
  • AST and ALT =< 2.5 times upper limit of normal
  • Fertile patients must use effective barrier contraception
  • No other invasive cancer (except nonmelanoma skin cancer) within the past 2 years
  • Patients who received curative treatment and have shown no evidence of recurrence within the past 2 years are eligible
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to lycopene (e.g., other carotenoids, including lutein and beta-carotene)
  • More than 30 days since prior regular (> once weekly) lycopene supplementation (>= 15 mg/day) and meets the following criteria: no more than 2 servings of tomato sauce, juice, or soup per week; no more than 4 servings of grapefruit, raw tomato, or watermelon per week
  • Must not consume 1 serving of tomato sauce, juice, or soup per week AND more than 2 servings of grapefruit, raw tomato, or watermelon per week
  • More than 30 days since prior and no concurrent investigational medication
  • No concurrent chemotherapy, radiotherapy, hormonal therapy, or immunotherapy
  • No history of allergy to foods containing lycopene (e.g., tomatoes or tomato products, watermelon, guava, and pink grapefruit)
  • No concurrent uncontrolled illness including, but not limited to, any of the following: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness/social situations that would limit compliance with study requirements
  • No prior therapy for prostate cancer, including radiotherapy to the prostate or pelvis, androgen ablation, or antiandrogen systemic therapy
  • No other concurrent lycopene (>= 15 mg/day)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450749

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: James Eastham M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00450749     History of Changes
Other Study ID Numbers: NCI-2009-00857, NCI-2009-00857, MSKCC-06118, MDA-CC-2006-0388, CDR0000653464, CDR0000532938, 06-118, 2006-0388, MDA04-3-01, P30CA016672, N01CN35159
Study First Received: March 20, 2007
Results First Received: March 30, 2012
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
Lycopene
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014