Stage I Prostate CancerPhase 2NCT01928485
Green Tea Extract in Treating Patients With Low-Risk Prostate Cancer
A Phase 2 study testing active surveillance, Sunphenon and laboratory biomarker analysis in people with Stage I Prostate Cancer and Stage IIA Prostate Cancer, run by Sanjay Gupta PhD at 1 site in United States.
Trial summary
This randomized phase II trial studies how well green tea extract works in treating patients with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or slow the growth of certain cancers. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- What is being tested?
- active surveillance, Sunphenon and laboratory biomarker analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2013to 7 Nov 2016
- 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 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be males with histologically confirmed and clinically localized low-grade and low-volume prostate cancer demonstrated at the time of initial diagnosis
- Prostate biopsy must be positive for cancer: clinically localized T1c or T2a, PSA ≤ 10, Gleason ≤ 6 at the time of initial diagnosis. As the intent of serial biopsy is to ensure that the disease has not progressed to the stage or grade of requiring treatment, the presence of a negative biopsy following an initial positive biopsy (coupled with clinically localized T1c or T2a PSA ≤10 and Gleason ≤6 for a patient who has had no treatment, will not render the patient ineligible. If the consecutive biopsy is either negative, or if positive and remains clinically localized T1c or T2a, PSA≤10 and Gleason ≤6, the patient is eligible
- Willing to refrain from the concurrent use of high-dose (200 mg or higher per day) of vitamins, antioxidants, Proscar, Advodart, and anti-inflammatory agents
- Willing to sign an Institutional Review Board (IRB)-approved informed consent document and adhere to the protocol
- Willing and able to take oral medications
- Willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea for the duration of the study
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- Subjects must have newly diagnosed (within 1 year), previously untreated prostate cancer without other malignancy; therefore, no prior therapies are permitted
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ institutional upper limit of normal
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ institutional upper limit of normal
- Serum creatinine within normal institutional limits
- Subject must be willing to limit alcohol to moderate use which is defined as: up to one drink a day for women or two drinks a day for men; examples of one drink include:
- Beer: 12 fluid ounces (355 milliliters)
- Wine: 5 fluid ounces (148 milliliters)
- Distilled spirits (80 proof): 1.5 fluid ounces (44 milliliters)
Who cannot join
- Patients who are receiving any other investigational agents
- Patients with known concurrent malignancy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Sunphenon 90 DCF-T or other agents used in this study
- Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization; or concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week
- Patients with 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
- Patients who have received prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy
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- Signs or symptoms of progressive or uncontrolled liver disease
- Known malignancy at any site within the last two years; with the exception of basal cell carcinoma (BCC)
- Participation in a research trial within the past three months
- Any condition that would interfere with the ability to give informed consent or comply with the study protocol
- Hypersensitivity to tea products or any of the inactive ingredients found in the drug product capsules
- Patients with a known history of Gilbert's syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Randomized Study of Sunphenon Decaffeinated Capsules in Men With Low-Risk Prostate Cancer on Active Surveillance
This randomized phase II trial studies how well green tea extract works in treating patients with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or slow the growth of certain cancers.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess changes in the levels of total- and free- prostate-specific antigen (PSA), free to total PSA (f/tPSA) ratio and insulin-like growth factor 1 (IGF-I) levels and IGF-I/free PSA (fPSA) ratio, insulin-like growth factor binding protein 3 (IGFBP-3), and vascular endothelial growth factor (VEGF) after Sunphenon 90DCF-T (green tea extract) supplementation during the period between recruitment and biopsy.
SECONDARY OBJECTIVES:
- To evaluate the effects of oral ingestion on Sunphenon 90DCF-T supplementation during the period between recruitment and biopsy in the reactivation of glutathione S-transferase pi 1 (GSTP1) (whole blood deoxyribonucleic acid [DNA]); levels of antigen identified by monoclonal antibody Ki-67 (Ki-67), cluster of differentiation 34 (CD34), and M30 apopotosense in the prostate tissue.
II. To evaluate the effects of oral ingestion of Sunphenon 90DCF-T during the period between recruitment and biopsy on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture and quality of life (QOL) assessment.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients undergo active surveillance for 52 weeks.
ARM B: Patients receive green tea extract orally (PO) once daily (QD) for 52 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
- Being tested
- active surveillance, Sunphenon, laboratory biomarker analysis, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active surveillanceOther
Undergo active surveillance
SunphenonDrug
Also called Green tea polyphenols, Green tea extract, Sunphenon 90DCD-T
Given PO
laboratory biomarker analysisOther
Correlative studies
Questionnaire AdministrationOther
Also called The Expanded Prostate Cancer Index Composite (EPIC-26), American Urological Association (AUA) symptom index, Quality of Life (SF-12), Food Questionnaire
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (active surveillance) | Active comparator | Patients undergo active surveillance for 52 weeks. Receives: Other: active surveillance; Other: laboratory biomarker analysis; Other: Questionnaire Administration |
| Arm B (Sunphenon) | Experimental | Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Sunphenon; Other: laboratory biomarker analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total-PSA (tPSA) Levels
tPSA serum levels
Measured: From baseline at 52 weeks
Changes in the f/tPSA Ratio
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Measured: From baseline at 52 weeks
Changes in IGF-I Levels
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Measured: Baseline to 52 weeks
Changes in the IGF-I/fPSA Ratio
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Measured: Baseline up to 52 weeks
Changes in the Level of IGFBP-3
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Measured: Baseline to 52 weeks
Changes in the Level of VEGF
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Measured: Baseline up to 52 weeks
Changes in the Levels of Free-PSA (f-PSA)
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Measured: from baseline at 52 weeks
Secondary outcomes (15)
Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA)
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures analysis of variance (ANOVA).
Measured: Up to 52 weeks
Effects of Oral Ingestion of Green Tea Extract on Levels of Ki-67
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
Measured: Up to 52 weeks
Effects of Oral Ingestion of Green Tea Extract on Levels of CD34
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
Measured: Up to 52 weeks
Effects of Oral Ingestion of Green Tea Extract on Levels of M30 Apoptosense in the Prostate Tissue
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
Measured: Up to 52 weeks
Effects of Oral Ingestion of Sunphenon 90 DCF-T on Histologic Findings in Prostate Tissue Such as Nuclear Measurements Viz. Shape, Size and Texture
Effects of oral ingestion of Sunphenon 90 DCF-T on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture
Measured: Up to 52 weeks
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Measured: Baseline
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Measured: At 24 weeks
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Measured: at 3.5 years from start of study
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
Measured: Baseline
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
Measured: At 24 weeks
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
Measured: At 3.5 years from start of study
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.
Measured: Baseline
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.
Measured: At 24 weeks
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.
Measured: At 3.5 years from start of study
Sexual Health Inventory in Men Score (SHIM Score)
SHIM score - The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows:
22 - 25: No significant erectile dysfunction 17 - 21: Mild erectile dysfunction 12 - 16: Mild-to-moderate erectile dysfunction 8 - 11: Moderate erectile dysfunction 5 - 7: Severe erectile dysfunction
Reported values are an average of three collected data points per participant: at baseline, at 24 weeks, and at end of study (3.5 years)
Measured: Baseline, at 24 weeks, and at 3.5 years from start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2013 (estimated)
- Study start30 Aug 2013
- Primary completion5 Oct 2016
- Study completion7 Nov 2016
Why it stopped: Slow Accrual
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 Stage I Prostate CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjay Gupta PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sanjay Gupta PhD, Case Comprehensive Cancer Center
- Investigators
- Lee Ponsky, MD, Principal investigator, Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928485
- Sponsor's protocol ID
- CASE6812
- Other IDs
- NCI-2013-01372
- Status last verified
- Sep 2020
- First submitted
- 21 Aug 2013
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Sunphenon Decaffeinated Capsules in Men With Low-Risk Prostate Cancer on Active Surveillance
- ClinicalTrials.gov ID
- NCT01928485
- Acronym / sponsor ID
- CASE6812
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sanjay Gupta PhDUniversity, hospital or other
- Study start
- 30 Aug 2013 (actual)
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 7 Nov 2016 (actual)
- First posted
- 26 Aug 2013 (estimated)
- Results
- Posted 3 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well green tea extract works in treating patients with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or slow the growth of certain cancers.
Detailed description
PRIMARY OBJECTIVES:
- To assess changes in the levels of total- and free- prostate-specific antigen (PSA), free to total PSA (f/tPSA) ratio and insulin-like growth factor 1 (IGF-I) levels and IGF-I/free PSA (fPSA) ratio, insulin-like growth factor binding protein 3 (IGFBP-3), and vascular endothelial growth factor (VEGF) after Sunphenon 90DCF-T (green tea extract) supplementation during the period between recruitment and biopsy.
SECONDARY OBJECTIVES:
- To evaluate the effects of oral ingestion on Sunphenon 90DCF-T supplementation during the period between recruitment and biopsy in the reactivation of glutathione S-transferase pi 1 (GSTP1) (whole blood deoxyribonucleic acid [DNA]); levels of antigen identified by monoclonal antibody Ki-67 (Ki-67), cluster of differentiation 34 (CD34), and M30 apopotosense in the prostate tissue.
II. To evaluate the effects of oral ingestion of Sunphenon 90DCF-T during the period between recruitment and biopsy on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture and quality of life (QOL) assessment.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients undergo active surveillance for 52 weeks.
ARM B: Patients receive green tea extract orally (PO) once daily (QD) for 52 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (active surveillance) | Active comparator | Other: active surveillance, Other: laboratory biomarker analysis, Other: Questionnaire AdministrationPatients undergo active surveillance for 52 weeks. |
| Arm B (Sunphenon) | Experimental | Drug: Sunphenon, Other: laboratory biomarker analysis, Other: Questionnaire AdministrationPatients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must be males with histologically confirmed and clinically localized low-grade and low-volume prostate cancer demonstrated at the time of initial diagnosis
- Prostate biopsy must be positive for cancer: clinically localized T1c or T2a, PSA ≤ 10, Gleason ≤ 6 at the time of initial diagnosis. As the intent of serial biopsy is to ensure that the disease has not progressed to the stage or grade of requiring treatment, the presence of a negative biopsy following an initial positive biopsy (coupled with clinically localized T1c or T2a PSA ≤10 and Gleason ≤6 for a patient who has had no treatment, will not render the patient ineligible. If the consecutive biopsy is either negative, or if positive and remains clinically localized T1c or T2a, PSA≤10 and Gleason ≤6, the patient is eligible
- Willing to refrain from the concurrent use of high-dose (200 mg or higher per day) of vitamins, antioxidants, Proscar, Advodart, and anti-inflammatory agents
- Willing to sign an Institutional Review Board (IRB)-approved informed consent document and adhere to the protocol
- Willing and able to take oral medications
Key exclusion criteria (12 listed)
- Patients who are receiving any other investigational agents
- Patients with known concurrent malignancy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Sunphenon 90 DCF-T or other agents used in this study
- Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization; or concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week
- Patients with 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
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 |
|---|---|---|
| active surveillanceUndergo active surveillance | Other | Arm A (active surveillance) |
| SunphenonAlso: Green tea polyphenols, Green tea extract, Sunphenon 90DCD-TGiven PO | Drug | Arm B (Sunphenon) |
| laboratory biomarker analysisCorrelative studies | Other | Arm A (active surveillance), Arm B (Sunphenon) |
| Questionnaire AdministrationAlso: The Expanded Prostate Cancer Index Composite (EPIC-26), American Urological Association (AUA) symptom index, Quality of Life (SF-12), Food QuestionnaireAncillary studies | Other | Arm A (active surveillance), Arm B (Sunphenon) |
Primary outcome
Total-PSA (tPSA) Levels
Time frame: From baseline at 52 weeks
tPSA serum levels
Changes in the f/tPSA Ratio
Time frame: From baseline at 52 weeks
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Changes in IGF-I Levels
Time frame: Baseline to 52 weeks
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Changes in the IGF-I/fPSA Ratio
Time frame: Baseline up to 52 weeks
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Changes in the Level of IGFBP-3
Time frame: Baseline to 52 weeks
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Changes in the Level of VEGF
Time frame: Baseline up to 52 weeks
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Changes in the Levels of Free-PSA (f-PSA)
Time frame: from baseline at 52 weeks
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
15 secondary outcomes
Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA)
Time frame: Up to 52 weeks
Effects of Oral Ingestion of Green Tea Extract on Levels of Ki-67
Time frame: Up to 52 weeks
Effects of Oral Ingestion of Green Tea Extract on Levels of CD34
Time frame: Up to 52 weeks
Effects of Oral Ingestion of Green Tea Extract on Levels of M30 Apoptosense in the Prostate Tissue
Time frame: Up to 52 weeks
Effects of Oral Ingestion of Sunphenon 90 DCF-T on Histologic Findings in Prostate Tissue Such as Nuclear Measurements Viz. Shape, Size and Texture
Time frame: Up to 52 weeks
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Time frame: Baseline
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Time frame: At 24 weeks
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Time frame: at 3.5 years from start of study
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Time frame: Baseline
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Time frame: At 24 weeks
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Time frame: At 3.5 years from start of study
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Time frame: Baseline
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Time frame: At 24 weeks
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Time frame: At 3.5 years from start of study
Sexual Health Inventory in Men Score (SHIM Score)
Time frame: Baseline, at 24 weeks, and at 3.5 years from start of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lee Ponsky, MD principal investigator
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing active surveillance, Sunphenon and laboratory biomarker analysis in people with Stage I Prostate Cancer and Stage IIA Prostate Cancer, run by Sanjay Gupta PhD at 1 site 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 15 inclusion and 12 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: stopped early, as of the sponsor's last update on 22 Oct 2020. 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. 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 Mar 2020). 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?
Total-PSA (tPSA) Levels (time frame: From baseline at 52 weeks). The study lists 7 primary outcomes in all. 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 22 Oct 2020.