Prostatic HyperplasiaPhase 2NCT00596011
Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia
A Phase 2 study testing Polyphenon E in people with Prostatic Hyperplasia, run by H. Lee Moffitt Cancer Center and Research Institute at 10 sites in United States.
Trial summary
The purpose of this study was to determine whether the daily consumption of decaffeinated green tea catechins (Polyphenon E®) for 1 year reduces the rate of progression to prostate cancer (PCa) in men diagnosed with HGPIN or ASAP. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Polyphenon E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 Nov 2007to 27 Jul 2018
- 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 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with a diagnosis of HGPIN or ASAP in a minimum of 1 of 8 cores from a biopsy performed within six months of study entry. Diagnosis of HGPIN or ASAP (which includes men with ASAP and HGPIN) via trans-rectal ultrasound (TRUS biopsy) is also considered acceptable for inclusion.
- Prostate biopsy with a minimum of 8 cores performed within 6 months of study entry that shows no evidence of cancer.
- 30-80 years of age at the time of registration
- PSA ≤10 ng/ml
- Omnivorous diet
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Show all 14Show fewer
- Participants must have normal organ and marrow function as demonstrated by the following parameters being within normal institutional limits: complete blood count (CBC); liver function tests (LFTs); albumin, total and direct bilirubin, alkaline phosphatase, aspartic transaminase (AST), alanine transaminase (ALT), and total protein), PT/PTT, and LDH; serum creatinine <1.5 mg/dl or measured creatinine clearance 60 cc/min
- Absence of consumption of toremifene citrate, finasteride, testosterone, dehydroepiandrosterone (DHEA) or other testosterone-like supplements or medications which have known impact on PSA within 30 days of informed consent, or dutasteride within 90 days of informed consent
- Absence of consumption of any nutritional or herbal supplements containing green tea or green tea polyphenols
- No or low regular tea consumption (no more than 3 servings of hot tea or 6 servings of iced tea per week)
- Willing to discontinue current vitamin/mineral supplement use and substitute with a standard multivitamin supplement provided for the study
- Willing to use an effective method of contraception, if the partner is of child-bearing age, while on study
- Willing to comply with proposed visit and treatment schedule
- Able to understand and willing to sign a written informed consent document
Who cannot join
- Evidence of acute prostatitis or urinary tract infection at the time of PSA measurement; men may be enrolled 30 days after completion of treatment, provided all other eligibility criteria are met
- Current or prior history of prostate cancer or other malignancies (exceptions include non-melanoma skin cancer or other cancer with no evidence of tumor recurrence 5 years after definitive treatment)
- History of renal or hepatic disease, including history of hepatitis B, C or delta
- Participation in any other investigational study or use of any other investigational agents within 30 days of study entry
- History of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to Polyphenon E or the inactive components present in Polyphenon E and placebo capsules.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any psychological, familial, sociological or other concomitant condition that would not allow adequate compliance with the study protocol
- History of medical conditions that may predispose the participant to gastrointestinal bleeding (acute or chronic gastritis or colitis, or acute diverticulitis or hemorrhoids)
- Members of all races and ethnic groups are eligible for this trial. Since this is an investigation targeting men with HGPIN or ASAP, women are not eligible for the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Chicago - Department of Surgery
Chicago, Illinois, 60637
University of Florida/Shands-Department of Urology
Gainesville, Florida, 32610
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Watson Clinic Center for Research, Inc.
Lakeland, Florida, 33805
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
Jefferson Medical College - Department of Urology
Philadelphia, Pennsylvania, 19107
Overton Brooks VA Medical Center
Shreveport, Louisiana, 71101-4295
LSU Health Sciences Center, Feist-Weiller Cancer Center
Shreveport, Louisiana, 71130
H Lee Moffitt Cancer Center
Tampa, Florida, 33612
James A Haley VA
Tampa, Florida, 33612
About this study
Official title: Phase II, Randomized, Double-blind, Multi-centered Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia (HGPIN) or Atypical Small Acinar Proliferation (ASAP)
The purpose of this study was to determine whether the daily consumption of decaffeinated green tea catechins (Polyphenon E®) for 1 year reduces the rate of progression to prostate cancer (PCa) in men diagnosed with HGPIN or ASAP. The aim was to recruit and treat 240 (120 men/arm) men diagnosed with the prostate condition HGPIN or ASAP with a capsule form of standardized green tea extract called Polyphenon E or placebo for a 12-month period and see if it can prevent progression of the prostate condition to prostate cancer. Investigators wanted to see if Polyphenon E reduces lower urinary tract symptoms and if this can be taken safely over one year. Investigators wanted to study how Polyphenon E is able to slow the progression to prostate cancer, or the mechanism of action of Polyphenon E. If the safety and the effects of Polyphenon E on slowing down the progression of prostate cancer is shown in our study, this will be a safe way of treating men who are at high risk or men like you who have a prostate condition that increases your chances of getting prostate cancer, so that we can prevent prostate cancer in the future.
Read the detailed description
At the baseline/randomization visit, a QOL (Medical Outcomes Study Short Form-36) and lower urinary tract symptoms (LUTS) score assessment will be completed; urine and serum will be collected for measurement of diagnostic markers; plasma will be collected for measurement of baseline catechin levels; serum will be collected for banking; and diet recall forms will be collected. Participants will be equally randomized to blinded treatment with either Polyphenon E 200 mg EGCG bid or matching placebo, and an initial supply of study drug will be dispensed. All participants will also be provided with a standard multivitamin/mineral supplement to assure consistent, appropriate nutrient intake among study participants. The planned intervention period is 12 months; participants will return for monthly clinic visits during the intervention period. At each monthly clinic visit, blood will be drawn for repeat hepatic function panel, lactate dehydrogenase (LDH) and prothrombin time/partial thromboplastin time (PT/PTT), and participants will be interviewed to review and capture information from study agent intake log (pill count), assess signs and symptoms and concomitant medications; additional study medication will be dispensed as needed. After 3 and 6 months of intervention, blood will be drawn for serum chemistry and hematology, and LUTS and QOL assessments will be performed. In addition, at the 6 month visit, two-day diet recall forms will be collected, blood will be drawn for plasma catechin measurements and serum banking, serum and urine will be collected for diagnostic marker measurement, and repeat digital rectal exam (DRE) and prostate specific antigen (PSA) will be performed. If there is a palpable prostate nodule or confirmed PSA increase (>0.75 ng/ml) at 6 months, a repeat biopsy will be performed. If the 6-month biopsy shows evidence of disease progression, participants will stop intervention and proceed to the post-intervention assessment; otherwise, intervention will continue through month 12. At the end of intervention (maximum of 12 months), a repeat prostate biopsy will be performed for post-intervention endpoint measurements. In addition, the physical exam and DRE, LUTS and QOL will be repeated, and 2-day diet recall forms will be collected. Blood will be drawn for serum chemistry and hematology, PSA, hepatic function panel, LDH, PT/PTT; serum and urine will be collected for diagnostic marker measurement; plasma will be collected for catechin measurements; and serum will be collected for banking. Participants will be interviewed to review and capture information from study agent intake log (pill count), assess signs and symptoms and concomitant medications.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Polyphenon E, Placebo
- Keywords
- prostate cancer, PIN, polyphenon E, EGCG
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenon EDrug
Also called green tea catechins, PolyE
Polyphenon E, at a dose of 400 mgs EGCG (200 mgs BID) for 1 year in men diagnosed with HGPIN and ASAP.
PlaceboDrug
Matching placebo BID
| Study group | Role | What they receive |
|---|---|---|
| Polyphenon E Treatment | Active comparator | Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID) Receives: Drug: Polyphenon E |
| Placebo Administration | Placebo comparator | Matching placebo BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Progression to Prostate Cancer (PCa)
Number of participants with diagnosis of high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP) who progressed to prostate cancer (PCa) at one year.
Measured: 12 months
Rate of Progression From HGPIN to ASAP or PCa
Analyses of participants reaching a definitive endpoint. Number of baseline HGPIN participants who progressed to ASAP or PCa.
Measured: 12 months
Secondary outcomes (3)
Treatment Emergent Adverse Events (AEs)
Safety of Polyphenon E (200 mg EGCG bid for one year) in men with HGPIN or ASAP. Number of participants with AEs Possibly or Probably related to treatment.
Measured: 12 months
Occurrence of Grade 3 or Higher Adverse Events (AEs)
Number of participants with AEs grade 3 or higher, per treatment arm.
Measured: 12 months
Median Serum Total Prostatic Specific Antigen (tPSA)
Median ng/mL serum tPSA post treatment, per treatment arm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study start14 Nov 2007
- Primary completion25 Mar 2014
- Study completion27 Jul 2018
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nagi Kumar, PhD, Principal investigator, H. Lee Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596011
- Sponsor's protocol ID
- MCC-15008
- Other IDs
- R01CA12060-01A1
- Status last verified
- Oct 2019
- First submitted
- 7 Jan 2008
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kim SJ, Amankwah E, Connors S, Park HY, Rincon M, Cornnell H, Chornokur G, Hashim AI, Choi J, Tsai YY, Engelman RW, Kumar N, Park JY. Safety and chemopreventive effect of Polyphenon E in preventing early and metastatic progression of prostate cancer in TRAMP mice. Cancer Prev Res (Phila). 2014 Apr;7(4):435-44. doi: 10.1158/1940-6207.CAPR-13-0427-T. Epub 2014 Feb 5.
PubMed 24501325Kumar NB, Pow-Sang JM, Spiess PE, Park JY, Chornokur G, Leone AR, Phelan CM. Chemoprevention in African American Men With Prostate Cancer. Cancer Control. 2016 Oct;23(4):415-423. doi: 10.1177/107327481602300413.
PubMed 27842331Kumar NB, Pow-Sang J, Spiess PE, Park J, Salup R, Williams CR, Parnes H, Schell MJ. Randomized, placebo-controlled trial evaluating the safety of one-year administration of green tea catechins. Oncotarget. 2016 Oct 25;7(43):70794-70802. doi: 10.18632/oncotarget.12222.
PubMed 28053292Kumar NB, Patel R, Pow-Sang J, Spiess PE, Salup R, Williams CR, Schell MJ. Long-term supplementation of decaffeinated green tea extract does not modify body weight or abdominal obesity in a randomized trial of men at high risk for prostate cancer. Oncotarget. 2017 Jun 29;8(58):99093-99103. doi: 10.18632/oncotarget.18858. eCollection 2017 Nov 17.
PubMed 29228755Kumar NB, Pow-Sang J, Egan KM, Spiess PE, Dickinson S, Salup R, Helal M, McLarty J, Williams CR, Schreiber F, Parnes HL, Sebti S, Kazi A, Kang L, Quinn G, Smith T, Yue B, Diaz K, Chornokur G, Crocker T, Schell MJ. Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention. Cancer Prev Res (Phila). 2015 Oct;8(10):879-87. doi: 10.1158/1940-6207.CAPR-14-0324. Epub 2015 Apr 14.
PubMed 25873370
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double-blind, Multi-centered Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia (HGPIN) or Atypical Small Acinar Proliferation (ASAP)
- ClinicalTrials.gov ID
- NCT00596011
- Acronym / sponsor ID
- MCC-15008
- Conditions
- Prostatic Hyperplasia
- Keywords
- prostate cancer, PIN, polyphenon E, EGCG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Nov 2007 (actual)
- Primary completion
- 25 Mar 2014 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 3 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine whether the daily consumption of decaffeinated green tea catechins (Polyphenon E®) for 1 year reduces the rate of progression to prostate cancer (PCa) in men diagnosed with HGPIN or ASAP. The aim was to recruit and treat 240 (120 men/arm) men diagnosed with the prostate condition HGPIN or ASAP with a capsule form of standardized green tea extract called Polyphenon E or placebo for a 12-month period and see if it can prevent progression of the prostate condition to prostate cancer. Investigators wanted to see if Polyphenon E reduces lower urinary tract symptoms and if this can be taken safely over one year. Investigators wanted to study how Polyphenon E is able to slow the progression to prostate cancer, or the mechanism of action of Polyphenon E. If the safety and the effects of Polyphenon E on slowing down the progression of prostate cancer is shown in our study, this will be a safe way of treating men who are at high risk or men like you who have a prostate condition that increases your chances of getting prostate cancer, so that we can prevent prostate cancer in the future.
Detailed description
At the baseline/randomization visit, a QOL (Medical Outcomes Study Short Form-36) and lower urinary tract symptoms (LUTS) score assessment will be completed; urine and serum will be collected for measurement of diagnostic markers; plasma will be collected for measurement of baseline catechin levels; serum will be collected for banking; and diet recall forms will be collected. Participants will be equally randomized to blinded treatment with either Polyphenon E 200 mg EGCG bid or matching placebo, and an initial supply of study drug will be dispensed. All participants will also be provided with a standard multivitamin/mineral supplement to assure consistent, appropriate nutrient intake among study participants. The planned intervention period is 12 months; participants will return for monthly clinic visits during the intervention period. At each monthly clinic visit, blood will be drawn for repeat hepatic function panel, lactate dehydrogenase (LDH) and prothrombin time/partial thromboplastin time (PT/PTT), and participants will be interviewed to review and capture information from study agent intake log (pill count), assess signs and symptoms and concomitant medications; additional study medication will be dispensed as needed. After 3 and 6 months of intervention, blood will be drawn for serum chemistry and hematology, and LUTS and QOL assessments will be performed. In addition, at the 6 month visit, two-day diet recall forms will be collected, blood will be drawn for plasma catechin measurements and serum banking, serum and urine will be collected for diagnostic marker measurement, and repeat digital rectal exam (DRE) and prostate specific antigen (PSA) will be performed. If there is a palpable prostate nodule or confirmed PSA increase (>0.75 ng/ml) at 6 months, a repeat biopsy will be performed. If the 6-month biopsy shows evidence of disease progression, participants will stop intervention and proceed to the post-intervention assessment; otherwise, intervention will continue through month 12. At the end of intervention (maximum of 12 months), a repeat prostate biopsy will be performed for post-intervention endpoint measurements. In addition, the physical exam and DRE, LUTS and QOL will be repeated, and 2-day diet recall forms will be collected. Blood will be drawn for serum chemistry and hematology, PSA, hepatic function panel, LDH, PT/PTT; serum and urine will be collected for diagnostic marker measurement; plasma will be collected for catechin measurements; and serum will be collected for banking. Participants will be interviewed to review and capture information from study agent intake log (pill count), assess signs and symptoms and concomitant medications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyphenon E Treatment | Active comparator | Drug: Polyphenon EPolyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID) |
| Placebo Administration | Placebo comparator | Drug: PlaceboMatching placebo BID |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men with a diagnosis of HGPIN or ASAP in a minimum of 1 of 8 cores from a biopsy performed within six months of study entry. Diagnosis of HGPIN or ASAP (which includes men with ASAP and HGPIN) via trans-rectal ultrasound (TRUS biopsy) is also considered acceptable for inclusion.
- Prostate biopsy with a minimum of 8 cores performed within 6 months of study entry that shows no evidence of cancer.
- 30-80 years of age at the time of registration
- PSA ≤10 ng/ml
- Omnivorous diet
Key exclusion criteria (8 listed)
- Evidence of acute prostatitis or urinary tract infection at the time of PSA measurement; men may be enrolled 30 days after completion of treatment, provided all other eligibility criteria are met
- Current or prior history of prostate cancer or other malignancies (exceptions include non-melanoma skin cancer or other cancer with no evidence of tumor recurrence 5 years after definitive treatment)
- History of renal or hepatic disease, including history of hepatitis B, C or delta
- Participation in any other investigational study or use of any other investigational agents within 30 days of study entry
- History of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to Polyphenon E or the inactive components present in Polyphenon E and placebo capsules.
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 |
|---|---|---|
| Polyphenon EAlso: green tea catechins, PolyEPolyphenon E, at a dose of 400 mgs EGCG (200 mgs BID) for 1 year in men diagnosed with HGPIN and ASAP. | Drug | Polyphenon E Treatment |
| PlaceboMatching placebo BID | Drug | Placebo Administration |
Primary outcome
Rate of Progression to Prostate Cancer (PCa)
Time frame: 12 months
Number of participants with diagnosis of high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP) who progressed to prostate cancer (PCa) at one year.
Rate of Progression From HGPIN to ASAP or PCa
Time frame: 12 months
Analyses of participants reaching a definitive endpoint. Number of baseline HGPIN participants who progressed to ASAP or PCa.
3 secondary outcomes
Treatment Emergent Adverse Events (AEs)
Time frame: 12 months
Occurrence of Grade 3 or Higher Adverse Events (AEs)
Time frame: 12 months
Median Serum Total Prostatic Specific Antigen (tPSA)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24501325Kim SJ, Amankwah E, Connors S, Park HY, Rincon M, Cornnell H, Chornokur G, Hashim AI, Choi J, Tsai YY, Engelman RW, Kumar N, Park JY. Safety and chemopreventive effect of Polyphenon E in preventing early and metastatic progression of prostate cancer in TRAMP mice. Cancer Prev Res (Phila). 2014 Apr;7(4):435-44. doi: 10.1158/1940-6207.CAPR-13-0427-T. Epub 2014 Feb 5.
- Results publication: PubMed 27842331Kumar NB, Pow-Sang JM, Spiess PE, Park JY, Chornokur G, Leone AR, Phelan CM. Chemoprevention in African American Men With Prostate Cancer. Cancer Control. 2016 Oct;23(4):415-423. doi: 10.1177/107327481602300413.
- Results publication: PubMed 28053292Kumar NB, Pow-Sang J, Spiess PE, Park J, Salup R, Williams CR, Parnes H, Schell MJ. Randomized, placebo-controlled trial evaluating the safety of one-year administration of green tea catechins. Oncotarget. 2016 Oct 25;7(43):70794-70802. doi: 10.18632/oncotarget.12222.
- Results publication: PubMed 29228755Kumar NB, Patel R, Pow-Sang J, Spiess PE, Salup R, Williams CR, Schell MJ. Long-term supplementation of decaffeinated green tea extract does not modify body weight or abdominal obesity in a randomized trial of men at high risk for prostate cancer. Oncotarget. 2017 Jun 29;8(58):99093-99103. doi: 10.18632/oncotarget.18858. eCollection 2017 Nov 17.
- Derived from this study: PubMed 25873370Kumar NB, Pow-Sang J, Egan KM, Spiess PE, Dickinson S, Salup R, Helal M, McLarty J, Williams CR, Schreiber F, Parnes HL, Sebti S, Kazi A, Kang L, Quinn G, Smith T, Yue B, Diaz K, Chornokur G, Crocker T, Schell MJ. Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention. Cancer Prev Res (Phila). 2015 Oct;8(10):879-87. doi: 10.1158/1940-6207.CAPR-14-0324. Epub 2015 Apr 14.
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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.
Nagi Kumar, PhD principal investigator
H. Lee Moffitt Cancer Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polyphenon E in people with Prostatic Hyperplasia, run by H. Lee Moffitt Cancer Center and Research Institute at 10 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 14 inclusion and 8 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 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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 3 Sep 2014). 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?
Rate of Progression to Prostate Cancer (PCa) (time frame: 12 months). 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 NCT00596011, which also lists 5 linked publications.
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 4 Oct 2019.