Adenocarcinoma of the ProstatePhase 2NCT00450749

Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer

A Phase 2 study testing therapeutic conventional surgery, laboratory biomarker analysis and lycopene in people with Adenocarcinoma of the Prostate and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer
What is being tested?: therapeutic conventional surgery, laboratory biomarker analysis and lycopene
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Feb 2008to May 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Placebo Controlled Trial of Preoperative Lycopene Supplementation in Prostate Cancer Patients

Read the detailed description

PRIMARY OBJECTIVES:

Compare the differences in tissue concentrations of lycopene in patients with prostate cancer undergoing radical prostatectomy treated with different doses of neoadjuvant lycopene supplementation.

II. Compare the change in serum lycopene concentration from baseline and at 4-7 weeks in patients treated with different doses of lycopene.

SECONDARY OBJECTIVES:

Determine the effect of this treatment in down-regulating 5-alpha-reductase activity by measuring the change in the ratio of testosterone (T) to dihydrotestosterone (DHT) in serum at baseline and at 4-7 weeks and the ratio of T:DHT in prostatic surgical tissue post-treatment.

II. Determine the effect of this treatment in attenuating baseline blood serum concentrations of total prostate-specific antigen (PSA), free PSA, and human kallikrein 2 in these patients.

III. Determine the effect of this treatment on growth potential by examining post-treatment radical prostatectomy tissue specimens for proliferative index (PI) by Ki-67 expression, apoptotic index (AI) by TUNEL assay, and PI:AI ratio in these patients.

IV. Determine the effect of this treatment in modulating putative biomarkers of lycopene efficacy, including serum concentrations of insulin-like growth factor (IGF)-1 and IGF binding protein-3, lymphocyte oxidative DNA damage capacity by Comet assay, and GST-pi expression in prostatic tissue from these patients.

Compare the histological effect of different doses of lycopene on putative prognostic features, including the presence and extent of high-grade prostatic intraepithelial neoplasia, prostatitis, total tumor volume, local invasion (vascular and lymphatic, capsular, seminal vesicle), pathologic stage, Gleason score, surgical margins, and lymph node status in these patients.

VI. Determine the effect of this treatment in modulating the RNA expression of androgen-related genes by microarray analysis in these patients.

OUTLINE:

This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive placebo orally (PO) once daily (QD) for 4-7 weeks, and then undergo radical prostatectomy.

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

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

Tumor samples are collected from prostatectomy for laboratory studies, including GST-pi expression by immunohistochemistry; histological analysis; microarray analysis of androgen-related genes; ratio of testosterone (T) to dihydrotestosterone (DHT); Ki-67 expression; and lycopene tumor-concentration measurement.

Patients undergo blood collection at baseline, week 4, and week 7 for laboratory studies, including serum lycopene concentration measurement; level of T or DHT by high-performance liquid chromatography/tandem mass spectrometry (HPLC/MS/MS) analysis; serum concentrations of total prostate-specific antigen (PSA), free PSA, and human kallikrein 2; lymphocyte oxidative DNA damage capacity; and serum concentrations of insulin-like growth factor (IGF)-1 and IGF binding protein-3 by radioimmunological assay.

Conditions: Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer
Being tested: placebo, therapeutic conventional surgery, laboratory biomarker analysis, lycopene
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboOther
Also called PLCB
Given PO
therapeutic conventional surgeryProcedure or surgery
Undergo radical prostatectomy
laboratory biomarker analysisOther
Correlative studies
lycopeneDrug
Also called all-trans-Lycopene, Lyc-O-Mato, LYCO, psi,psi-Carotene
Given PO

Study groups in NCT00450749
Study group	Role	What they receive
Arm I (placebo)	Placebo comparator	Patients receive placebo PO QD for 4-7 weeks, and then undergo radical prostatectomy. Receives: 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. Receives: 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. Receives: Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Drug: lycopene

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline and weeks 4 and 7

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008May 2010

First posted22 Mar 2007 (estimated)
Study startFeb 2008
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00450749
Sponsor's protocol ID: NCI-2009-00857
Other IDs: NCI-2009-00857, MSKCC-06118, MDA-CC-2006-0388, CDR0000653464, CDR0000532938, 06-118, 2006-0388, MDA04-3-01
Status last verified: Dec 2019
First submitted: 20 Mar 2007
Last updated: 18 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
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Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
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All Adenocarcinoma of the Prostate trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Placebo Controlled Trial of Preoperative Lycopene Supplementation in Prostate Cancer Patients
ClinicalTrials.gov ID: NCT00450749
Acronym / sponsor ID: NCI-2009-00857
Conditions: Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Feb 2008
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 22 Mar 2007 (estimated)
Results: Posted 16 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

Compare the differences in tissue concentrations of lycopene in patients with prostate cancer undergoing radical prostatectomy treated with different doses of neoadjuvant lycopene supplementation.

II. Compare the change in serum lycopene concentration from baseline and at 4-7 weeks in patients treated with different doses of lycopene.

SECONDARY OBJECTIVES:

Determine the effect of this treatment in down-regulating 5-alpha-reductase activity by measuring the change in the ratio of testosterone (T) to dihydrotestosterone (DHT) in serum at baseline and at 4-7 weeks and the ratio of T:DHT in prostatic surgical tissue post-treatment.

II. Determine the effect of this treatment in attenuating baseline blood serum concentrations of total prostate-specific antigen (PSA), free PSA, and human kallikrein 2 in these patients.

Compare the histological effect of different doses of lycopene on putative prognostic features, including the presence and extent of high-grade prostatic intraepithelial neoplasia, prostatitis, total tumor volume, local invasion (vascular and lymphatic, capsular, seminal vesicle), pathologic stage, Gleason score, surgical margins, and lymph node status in these patients.

VI. Determine the effect of this treatment in modulating the RNA expression of androgen-related genes by microarray analysis in these patients.

OUTLINE:

This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive placebo orally (PO) once daily (QD) for 4-7 weeks, and then undergo radical prostatectomy.

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Arm I (placebo)	Placebo comparator	Other: placebo, Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysisPatients receive placebo PO QD for 4-7 weeks, and then undergo radical prostatectomy.
Arm II (low-dose lycopene)	Experimental	Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysis, Drug: lycopenePatients receive low-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
Arm III (high-dose lycopene)	Experimental	Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysis, Drug: lycopenePatients receive high-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placeboAlso: PLCBGiven PO	Other	Arm I (placebo)
therapeutic conventional surgeryUndergo radical prostatectomy	Procedure or surgery	Arm I (placebo), Arm II (low-dose lycopene), Arm III (high-dose lycopene)
laboratory biomarker analysisCorrelative studies	Other	Arm I (placebo), Arm II (low-dose lycopene), Arm III (high-dose lycopene)
lycopeneAlso: all-trans-Lycopene, Lyc-O-Mato, LYCO, psi,psi-CaroteneGiven PO	Drug	Arm II (low-dose lycopene), Arm III (high-dose lycopene)

Primary outcome

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.
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.

9 secondary outcomes

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
Ratio of Testosterone (T) to Dihydrotestosterone (DHT) in Serum
Time frame: Baseline and at 4-7 weeks

Results and safety

Results posted to the registry on 16 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I Placebo	3	3
Arm II Low Dose Lycopene	3	2
Arm III High-Dose Lycopene	4	2

Primary outcome: Concentration of Lycopene in Prostatic Surgical Tissue

Time frame: At 4-7 weeks. Number. Unit: ug/dL

Measure	Arm I Placebo n = 2	Arm II Low Dose Lycopene n = 2	Arm III High-Dose Lycopene n = 2
Sample 1	0.663	0.378	0.723
Sample 2	0.165	0.749	NA

Population analysed: Tissue samples collected from five participants for measurement of lycopene levels, representing only 50% (5 of 10) of the participants' enrolled on-trial.

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

Time frame: Baseline and weeks 4 and 7. Median (Full Range). Unit: ug/dL

Measure	Arm I Placebo n = 3	Arm II Low Dose Lycopene n = 3	Arm III High-Dose Lycopene n = 4
Baseline	25.3 (16.2 to 38.9)	32.0 (31.1 to 99.0)	22.7 (21.2 to 24.2)
Week4	98.7 (77.4 to 127.7)	40.4 (18.7 to 62.1)	61.5 (42.7 to 86.3)
Week 7	125.8 (125.8 to 125.8)	52.8 (24.7 to 81.0)	44.4 (39.6 to 49.2)

Population analysed: 10 participants were analyzed at Baseline versus 8 at Week 4 and versus 5 at Week 7 due to drop out rate.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 13 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I Placebo	0 of 3 (0%)	0 of 3 (0%)	Not reported
Arm II Low Dose Lycopene	0 of 3 (0%)	0 of 3 (0%)	Not reported
Arm III High-Dose Lycopene	0 of 4 (0%)	3 of 4 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Adenocarcinoma of the Prostate

RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer
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RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Eastham principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of Lycopene in Prostatic Surgical Tissue (time frame: At 4-7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00450749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.