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Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00450749
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : July 16, 2012
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
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 or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : February 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Lycopene

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. Serum Levels (ug/dL) of Total Lycopene at Baseline and During Treatment by Group [ Time Frame: Baseline and weeks 4 and 7 ]
    Serum levels (ug/dL) of total lycopene at baseline and during treatment by group were measured.


Secondary Outcome Measures :
  1. Ratio of T:DHT in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ]
  2. Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2 [ Time Frame: Baseline and at 4-7 weeks ]
  3. Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ]
  4. Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3 [ Time Frame: At baseline and at 4-7 weeks ]
  5. Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay [ Time Frame: At baseline and at 4-7 weeks ]
  6. Expression of GST-pi in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ]
  7. Histological Characteristics of Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ]
  8. Modulation of Expression of Androgen-related Genes as Measured by Microarray in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ]
  9. Ratio of Testosterone (T) to Dihydrotestosterone (DHT) in Serum [ Time Frame: Baseline and at 4-7 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: James Eastham M.D. Anderson Cancer Center
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00450749    
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 Posted: March 22, 2007    Key Record Dates
Results First Posted: July 16, 2012
Last Update Posted: December 18, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Lycopene
Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents