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Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00450749
First Posted: March 22, 2007
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
  • Ratio of T:DHT in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ]
  • Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2 [ Time Frame: Baseline and at 4-7 weeks ]
  • Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ]
  • Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3 [ Time Frame: At baseline and at 4-7 weeks ]
  • Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay [ Time Frame: At baseline and at 4-7 weeks ]
  • Expression of GST-pi in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ]
  • Histological Characteristics of Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ]
  • Modulation of Expression of Androgen-related Genes as Measured by Microarray in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450749


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00450749     History of Changes
Other Study ID Numbers: NCI-2009-00857
NCI-2009-00857 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MSKCC-06118
MDA-CC-2006-0388
CDR0000653464
CDR0000532938
06-118
2006-0388 ( Other Identifier: M D Anderson Cancer Center )
MDA04-3-01 ( Other Identifier: DCP )
P30CA016672 ( U.S. NIH Grant/Contract )
N01CN35159 ( U.S. NIH Grant/Contract )
First Submitted: March 20, 2007
First Posted: March 22, 2007
Results First Submitted: March 30, 2012
Results First Posted: July 16, 2012
Last Update Posted: May 12, 2014
Last Verified: April 2013

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