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Study Summary
No. 2006-0388:.......Prostate......Jeri Kim......Genitourinary Medical Oncology
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Study Summary Title
Study Summary
Number:
2006-0388
Study Title:Phase II Placebo Controlled Trial of Preoperative Lycopene Supplementation in Prostate Cancer Patients.
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Physician New Patient Referral
Name:Jeri KimPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Genitourinary Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2830
Contact us about clinical trials
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General Information
Disease Group:ProstateSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
The interim clinic visit may take place 7-14 days prior to surgery (Week 4 + 1)
to coincide with the standard pre-anesthesia evaluation.
Treatment
Agents:
LycopeneHome Care:The patient is responsible for administration of the study medication. (3 pills
daily at assigned dose level)
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to learn if adding different doses
of lycopene to your diet will effect the levels of lycopene in your prostate
tissue and blood. Researchers also want to test if lycopene changes blood
"markers" that doctors use to check for prostate cancer.
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Study Objectives / Outcomes
Primary objective:
    • To compare the effects of 6 weeks (± 1 week) of preoperative supplementation of the following regimens prior to radical prostatectomy: A: placebo; B: 30 mg/day lycopene; C: 60 mg/day lycopene, by determining the: differences in tissue concentrations of lycopene in the radical prostatectomy specimen between treatment groups and change in serum lycopene concentration from baseline and at 6 weeks (± 1 week).

Secondary objectives:
    • To evaluate the effect of 6 weeks (± 1 week) of pre-prostatectomy lycopene supplementation (LS) in down regulating 5-alpha-reductase activity by determining the:
          a. change in the ratio of testosterone (T) to dihydrotestosterone (DHT) in serum from baseline and at 6 weeks (± 1 week).
          b. ratio of T:DHT in prostatic surgical tissue post-intervention
    • To evaluate the effect of LS in attenuating baseline blood serum concentrations of total PSA (tPSA), free PSA (fPSA) and human kallikrein 2 (hK2)
    • To evaluate the effect of LS on growth potential to be examined in the post-treatment radical prostatectomy specimen by:
          a. proliferative index (PI; by Ki-67)
          b. apoptotic index (AI; by TUNEL assay)
          c. ratio of PI:AI
    • To evaluate the effect of 6 weeks (± 1 week) of pre-prostatectomy LS in modulating putative biomarkers of lycopene efficacy including:
          a. serum concentrations of insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3)
          b. lymphocyte oxidative DNA damage capacity (using the Comet assay)
          c. GST-pi expression in prostatic tissue
    • To evaluate the histological effect of LS on various putative prognostic features including: the presence and extent of high grade prostatic intraepithelial neoplasia (HGPIN), prostatitis, total tumor volume, local invasion [vascular and lymphatic, capsular, seminal vesicle], pathologic stage, Gleason score, surgical margins, and lymph node status) among the treatment groups.
    • To evaluate the effect of 6 weeks (± 1 week) of pre-prostatectomy LS in modulating the RNA expression of androgen-related genes by microarray analysis
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Study Status Information
Study Activation / Registration Date:04/11/2008
IRB Review and Approval Date:06/07/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:84
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Men with localized, biopsy-proven adenocarcinoma of the prostate and planned radical prostatectomy

2) Age >/= 18 years. Because prostate cancer is so rare in males < 18 years of age, children are excluded from this study

3) ECOG performance status </= 2 (Karnofsky >/= 60%)

4) Participant meets the following laboratory eligibility criteria obtained during a time not to exceed 4 weeks prior to going on study: Leukocytes >/= 3000/microL, Platelets >/= 100,000/microL, Total bilirubin within normal institutional limits, AST (SGOT)/ALT (SGPT) </= 2.5 X institutional ULN, Creatinine within normal institutional limits

5) Although lycopene is known to be non-teratogenic and non-mutagenic, men must agree to use adequate contraception (barrier method of birth control or abstinence) prior to study entry and for the duration of study participation.

6) Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:1) Prior prostate cancer therapy (including radiation therapy to the prostate or pelvis, androgen ablation or antiandrogen systemic therapy)

2) The participant will need concurrent chemotherapy, radiotherapy, hormonal therapy or immunotherapy during the time of study

3) History of invasive cancer (excluding non-melanoma skin cancer) within the past two years. Participants who received curative treatment and have shown no evidence of recurrence for two years will be eligible.

4) Regular (more than once weekly) lycopene intake via supplementation and/or diet ( >/= 15 mg/d) within 30 days of the baseline visit. Participants will be excluded if they: ·have more than 2 servings of tomato sauce, juice, or soup per week OR ·have more than 4 servings of grape fruit, raw tomato, or watermelon per week OR ·have 1 serving of tomato sauce, juice or soup per week AND more than 2 servings of grape fruit, raw tomato, or watermelon per week

5) Finasteride (Proscar) or dutasteride (Avodart) treatment for the prior 6 months.

6) Alpha-sympathetic blocking agents (terazosin, doxazocin, tamsulosin) treatment for the prior 6 months

7) Participant has received any investigational medication within 30 days of the baseline visit or is scheduled to receive an investigational drug throughout the course of the study

8) History of allergic reactions attributed to compounds of similar chemical or biologic composition to lycopene eg. other carotenoids including lutein and beta-carotene; or a history of allergy to foods containing lycopene eg. tomatoes or tomato products, watermelon, guava, and pink grapefruit

9) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

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Links
Registration Number: NCT00450749
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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