Adenocarcinoma of the ProstatePhase 1NCT01912820
Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery
A Phase 1 study testing green tea extract, quercetin and therapeutic conventional surgery in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical prostatectomy. Side effects of green tea extract and quercetin in combination with green tea extract will also be evaluated. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer
- What is being tested?
- green tea extract, quercetin and therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2014to 10 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects consent to participate in the trial
- The subject has a diagnosis of adenocarcinoma of the prostate
- The subject is scheduled to undergo radical prostatectomy
- The subject agrees to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention
Who cannot join
- History of hepatitis or liver dysfunction
- Ongoing alcohol abuse
- Significant medical or psychiatric conditions that would make the patient a poor protocol candidate
- Prior sensitivity or allergic reaction to tea, tea products or tea and quercetin supplements
- Allergies to multiple food items or nutritional supplements
- Taking luteinizing hormone-releasing hormone (LHRH) agonists, androgen receptor blocking agents, finasteride, or has undergone bilateral orchiectomy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Administration Los Angeles Healthcare System
Los Angeles, California, 90073
Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled Two-Arm Study of Quercetin and Green Tea to Enhance the Bioavailability of Green Tea Polyphenols in Men Scheduled for Prostatectomy
This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical prostatectomy. Side effects of green tea extract and quercetin in combination with green tea extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies quercetin was found to enhance the anticancer effects of green tea. This trial is designed to translate these findings forward in a short-term human intervention trial.
Read the detailed description
PRIMARY OBJECTIVES:
- To investigate the prostate tissue concentration of epigallocatechin gallate (EGCG), epicatechin gallate (ECG) and quercetin and their methylated metabolites in men scheduled for prostatectomy and consuming green tea (GT)extract (N=15) or GTextract with quercetin (N=15) for 3 weeks prior to prostatectomy.
II. To determine the concentration of EGCG, ECG, epigallocatechin (EGC), epicatechin (EC) and quercetin and the methylated metabolites in plasma collected before (T=0) and two hours (T=2) after the intake of the morning dose of GTextract and placebo or GTextract with quercetin during the third week of intervention.
III. To determine the effect of GTextract/quercetin intervention on reducing the enzyme activity and protein and gene expression of catechol-O-methyltransferase (COMT) and deoxyribonucleic (DNA) (cytosine-5) methyltransferase 1 (DNMT1) as well as protein and gene expression of multidrug resistance transport protein 1 (MRP1) in prostate tissue collected in specific aim 1 and COMT activity in erythrocytes from blood collected at baseline and week 3.
IV. To determine the inter-individual variation in genotype of COMT in buffy coat DNA.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive GT extract orally (PO) twice daily (BID) and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.
ARM II: Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Being tested
- green tea extract, quercetin, placebo, therapeutic conventional surgery, laboratory biomarker analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green tea extractDietary supplement
Also called green tea polyphenols
Given PO
quercetinDrug
Also called C.I. natural yellow 10
Given PO
placeboOther
Also called PLCB
Given PO
therapeutic conventional surgeryProcedure or surgery
Undergo prostatectomy
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (quercetin, green tea extract) | Experimental | Patients receive GT extract PO BID and quercetin PO BID for 3-6 weeks before undergoing prostatectomy. Receives: Dietary Supplement: green tea extract; Drug: quercetin; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis |
| Arm II (GT extract, placebo) | Placebo comparator | Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy. Receives: Dietary Supplement: green tea extract; Other: placebo; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Green tea polyphenols, quercetin and their metabolite concentration in blood and prostate tissue
Means and standard deviation will be calculated and the statistical difference between treatment with GTextract + quercetin compared to GTextract + placebo will be determined using Student's t-test computed by one-way analysis of variance models.
Measured: On the day of surgery
Secondary outcomes (5)
Protein and gene expression of COMT in prostate tissue
Measured: Day of surgery
Protein and gene expression of DNMT1 in prostate tissue
Measured: Day of surgery
Protein and gene expression of MRP1 in prostate tissue
Measured: Day of surgery
COMT activity in red blood cells
Measured: Week 3
Genotype of COMT (high [H]/H, low [L]/L or H/L)
Gene-association analyses will be conducted for COMT polymorphic variants within each intervention group using SAS Genetics, version 9.1
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study start1 Jan 2014
- Primary completion31 Jan 2016
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susanne Henning, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912820
- Sponsor's protocol ID
- 12-000886
- Other IDs
- NCI-2013-01153, R03CA171583
- Status last verified
- Jun 2021
- First submitted
- 29 Jul 2013
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-Blind, Placebo-Controlled Two-Arm Study of Quercetin and Green Tea to Enhance the Bioavailability of Green Tea Polyphenols in Men Scheduled for Prostatectomy
- ClinicalTrials.gov ID
- NCT01912820
- Acronym / sponsor ID
- 12-000886
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical prostatectomy. Side effects of green tea extract and quercetin in combination with green tea extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies quercetin was found to enhance the anticancer effects of green tea. This trial is designed to translate these findings forward in a short-term human intervention trial.
Detailed description
PRIMARY OBJECTIVES:
- To investigate the prostate tissue concentration of epigallocatechin gallate (EGCG), epicatechin gallate (ECG) and quercetin and their methylated metabolites in men scheduled for prostatectomy and consuming green tea (GT)extract (N=15) or GTextract with quercetin (N=15) for 3 weeks prior to prostatectomy.
II. To determine the concentration of EGCG, ECG, epigallocatechin (EGC), epicatechin (EC) and quercetin and the methylated metabolites in plasma collected before (T=0) and two hours (T=2) after the intake of the morning dose of GTextract and placebo or GTextract with quercetin during the third week of intervention.
III. To determine the effect of GTextract/quercetin intervention on reducing the enzyme activity and protein and gene expression of catechol-O-methyltransferase (COMT) and deoxyribonucleic (DNA) (cytosine-5) methyltransferase 1 (DNMT1) as well as protein and gene expression of multidrug resistance transport protein 1 (MRP1) in prostate tissue collected in specific aim 1 and COMT activity in erythrocytes from blood collected at baseline and week 3.
IV. To determine the inter-individual variation in genotype of COMT in buffy coat DNA.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive GT extract orally (PO) twice daily (BID) and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.
ARM II: Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (quercetin, green tea extract) | Experimental | Dietary Supplement: green tea extract, Drug: quercetin, Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysisPatients receive GT extract PO BID and quercetin PO BID for 3-6 weeks before undergoing prostatectomy. |
| Arm II (GT extract, placebo) | Placebo comparator | Dietary Supplement: green tea extract, Other: placebo, Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysisPatients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects consent to participate in the trial
- The subject has a diagnosis of adenocarcinoma of the prostate
- The subject is scheduled to undergo radical prostatectomy
- The subject agrees to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention
Key exclusion criteria (6 listed)
- History of hepatitis or liver dysfunction
- Ongoing alcohol abuse
- Significant medical or psychiatric conditions that would make the patient a poor protocol candidate
- Prior sensitivity or allergic reaction to tea, tea products or tea and quercetin supplements
- Allergies to multiple food items or nutritional supplements
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 |
|---|---|---|
| green tea extractAlso: green tea polyphenolsGiven PO | Dietary supplement | Arm I (quercetin, green tea extract), Arm II (GT extract, placebo) |
| quercetinAlso: C.I. natural yellow 10Given PO | Drug | Arm I (quercetin, green tea extract) |
| placeboAlso: PLCBGiven PO | Other | Arm II (GT extract, placebo) |
| therapeutic conventional surgeryUndergo prostatectomy | Procedure or surgery | Arm I (quercetin, green tea extract), Arm II (GT extract, placebo) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (quercetin, green tea extract), Arm II (GT extract, placebo) |
Primary outcome
Green tea polyphenols, quercetin and their metabolite concentration in blood and prostate tissue
Time frame: On the day of surgery
Means and standard deviation will be calculated and the statistical difference between treatment with GTextract + quercetin compared to GTextract + placebo will be determined using Student's t-test computed by one-way analysis of variance models.
5 secondary outcomes
Protein and gene expression of COMT in prostate tissue
Time frame: Day of surgery
Protein and gene expression of DNMT1 in prostate tissue
Time frame: Day of surgery
Protein and gene expression of MRP1 in prostate tissue
Time frame: Day of surgery
COMT activity in red blood cells
Time frame: Week 3
Genotype of COMT (high [H]/H, low [L]/L or H/L)
Time frame: Week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
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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.
Susanne Henning, MD principal investigator
Jonsson Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing green tea extract, quercetin and therapeutic conventional surgery in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Green tea polyphenols, quercetin and their metabolite concentration in blood and prostate tissue (time frame: On the day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2021.