Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer

NCT00450749 | Completed Phase 2 Results

• 10 other identifiers: NCI-2009-00857MSKCC-06118MDA-CC-2006-0388CDR0000653464CDR000053293806-1182006-0388MDA04-3-01P30CA016672N01CN35159
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Concentration of Lycopene in Prostatic Surgical Tissue

  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.

  At 4-7 weeks

• Serum Levels (ug/dL) of Total Lycopene at Baseline and During Treatment by Group

  Serum levels (ug/dL) of total lycopene at baseline and during treatment by group were measured.

  Baseline and weeks 4 and 7

Secondary Outcomes (9)

• Ratio of T:DHT in Prostatic Surgical Tissue

  At 4-7 weeks

• Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2

  Baseline and at 4-7 weeks

• Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue

  At 4-7 weeks

• Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3

  At baseline and at 4-7 weeks

• Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay

  At baseline and at 4-7 weeks

Study Arms (3)

Arm I (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QD for 4-7 weeks, and then undergo radical prostatectomy.

Other: placebo; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis

Arm II (low-dose lycopene)

EXPERIMENTAL

Patients receive low-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.

Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Drug: lycopene

Arm III (high-dose lycopene)

EXPERIMENTAL

Patients receive high-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.

Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Drug: lycopene

Interventions

placebo OTHER

Given PO

Also known as: PLCB

Arm I (placebo)

therapeutic conventional surgery PROCEDURE

Undergo radical prostatectomy

Arm I (placebo); Arm II (low-dose lycopene); Arm III (high-dose lycopene)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (placebo); Arm II (low-dose lycopene); Arm III (high-dose lycopene)

lycopene DRUG

Given PO

Also known as: all-trans-Lycopene, Lyc-O-Mato, LYCO, psi,psi-Carotene

Arm II (low-dose lycopene); Arm III (high-dose lycopene)

Eligibility Criteria

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

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)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

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

Results Point of Contact

• Title: Powel H Brown, MD, PhD/Professor of Medicine and Cancer Prevention
• Organization: University of Texas MD Anderson Phase I/II Prevention Consortium

PHBrown@mdanderson.org

713-792-2830

Study Officials

• James Eastham

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: February 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 18, 2019
• Results First Posted: July 16, 2012

Record last verified: 2019-12

Locations

US (1)