Trial Outcomes & Findings for Green Tea Extract in Treating Patients With Low-Risk Prostate Cancer (NCT NCT01928485)
NCT ID: NCT01928485
Last Updated: 2020-10-22
Results Overview
tPSA serum levels
TERMINATED
PHASE2
6 participants
From baseline at 52 weeks
2020-10-22
Participant Flow
Participant milestones
| Measure |
Arm A (Active Surveillance)
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm A (Active Surveillance)
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Green Tea Extract in Treating Patients With Low-Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=2 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50-59 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline at 52 weeksPopulation: Participants with available PSA values
tPSA serum levels
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Total-PSA (tPSA) Levels
|
7.8 ng/mL
Standard Deviation 2.29
|
5.1 ng/mL
Standard Deviation NA
no standard deviation due to only 1 observation
|
PRIMARY outcome
Timeframe: From baseline at 52 weeksPopulation: Participants with available PSA values
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=3 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Changes in the f/tPSA Ratio
|
0.16 ratio
Standard Deviation 0.07
|
0.16 ratio
Standard Deviation NA
no standard deviation due to only 1 observation
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksThe difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=3 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Changes in IGF-I Levels
|
5.28 ng/mL
Standard Deviation 0.1
|
2.12 ng/mL
Standard Deviation NA
no standard deviation due to only 1 observation
|
PRIMARY outcome
Timeframe: Baseline up to 52 weeksThe difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=3 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Changes in the IGF-I/fPSA Ratio
|
4.48 ratio
Standard Deviation 0.77
|
3.02 ratio
Standard Deviation NA
no standard deviation due to only 1 observation
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksThe difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Changes in the Level of IGFBP-3
|
1.82 ng/mL
Standard Deviation 0.93
|
5.54 ng/mL
Standard Deviation NA
no standard deviation due to only 1 observation
|
PRIMARY outcome
Timeframe: Baseline up to 52 weeksThe difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Changes in the Level of VEGF
|
29.8 pg/mL
Standard Deviation 20.6
|
0 pg/mL
Standard Deviation NA
no standard deviation due to only 1 observation
|
PRIMARY outcome
Timeframe: from baseline at 52 weeksPopulation: Participants with available PSA values
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=3 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Changes in the Levels of Free-PSA (f-PSA)
|
1.2 ng/mL
Standard Deviation 0.17
|
0.7 ng/mL
Standard Deviation NA
no standard deviation due to only 1 observation
|
SECONDARY outcome
Timeframe: Up to 52 weeksThe temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures analysis of variance (ANOVA).
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA)
|
0.53 ng/mL
Standard Deviation 0.14
|
0.60 ng/mL
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: ROI staining scores could not be determined because no positive stained cells in post-biopsy specimens. Tissue from 3 participants in Arm A and 1 participant from Arm B was analysed.
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: ROI staining scores could not be determined because no positive stained cells in post-biopsy specimens. Tissue from 3 participants in Arm A and 1 participant from Arm B was analysed.
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: M30 levels could not be determined because there were no tumor cells in biopsy
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Could not be determined because there were no tumor cells in biopsy
Effects of oral ingestion of Sunphenon 90 DCF-T on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineQuality 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.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Urinary Incontinence
|
2.33 score on a scale
Standard Deviation 2.18
|
3.0 score on a scale
Standard Deviation 2.65
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Urinary Irritation
|
0.54 score on a scale
Standard Deviation 0.66
|
1.5 score on a scale
Standard Deviation 1.37
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Bowel Function
|
0.21 score on a scale
Standard Deviation 0.41
|
0.16 score on a scale
Standard Deviation 0.41
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Sexual Function
|
3.04 score on a scale
Standard Deviation 1.36
|
4.16 score on a scale
Standard Deviation 1.60
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Hormonal Function
|
0.05 score on a scale
Standard Deviation 0.22
|
0.0 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: At 24 weeksQuality 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.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Urinary Incontinence
|
2.66 score on a scale
Standard Deviation 2.14
|
3.0 score on a scale
Standard Deviation 2.65
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Urinary Irritation
|
0.46 score on a scale
Standard Deviation 0.66
|
1.5 score on a scale
Standard Deviation 1.64
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Bowel Function
|
0.16 score on a scale
Standard Deviation 0.38
|
0.33 score on a scale
Standard Deviation 0.51
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Sexual Function
|
3.12 score on a scale
Standard Deviation 1.15
|
4.16 score on a scale
Standard Deviation 1.60
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Hormonal Function
|
0.05 score on a scale
Standard Deviation 0.22
|
0.0 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: at 3.5 years from start of studyQuality 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.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Urinary Irritation
|
1.08 score on a scale
Standard Deviation 1.35
|
1.33 score on a scale
Standard Deviation 1.50
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Urinary Incontinence
|
2.41 score on a scale
Standard Deviation 1.97
|
3.0 score on a scale
Standard Deviation 2.65
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Bowel Function
|
0.54 score on a scale
Standard Deviation 0.83
|
0.16 score on a scale
Standard Deviation 0.41
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Sexual Function
|
3.08 score on a scale
Standard Deviation 1.21
|
3.83 score on a scale
Standard Deviation 1.47
|
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Hormonal Function
|
0.10 score on a scale
Standard Deviation 0.30
|
0.0 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: BaselineQuality 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.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
PCS
|
52.78 score on a scale
Standard Deviation 4.07
|
55.89 score on a scale
Standard Deviation 0.0
|
|
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
MCS
|
56.79 score on a scale
Standard Deviation 1.18
|
52.98 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: At 24 weeksQuality 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.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
PCS
|
53.48 score on a scale
Standard Deviation 4.82
|
55.89 score on a scale
Standard Deviation 0.0
|
|
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
MCS
|
55.78 score on a scale
Standard Deviation 5.38
|
52.98 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: At 3.5 years from start of studyQuality 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.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
PCS
|
53.53 score on a scale
Standard Deviation 4.54
|
57.23 score on a scale
Standard Deviation 0.0
|
|
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
MCS
|
56.04 score on a scale
Standard Deviation 1.09
|
55.92 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: BaselineUrinary 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.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
|
3.5 score on a scale
Standard Deviation 3.1
|
21 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: At 24 weeksUrinary 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.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
|
5.75 score on a scale
Standard Deviation 2.87
|
19.0 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: At 3.5 years from start of studyUrinary 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.
Outcome measures
| Measure |
Arm A (Active Surveillance)
n=4 Participants
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=1 Participants
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
|
9.5 score on a scale
Standard Deviation 11.26
|
19.0 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline, at 24 weeks, and at 3.5 years from start of studyPopulation: Data were not collected
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)
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Active Surveillance)
Arm B (Sunphenon)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A (Active Surveillance)
n=4 participants at risk
Patients undergo active surveillance for 52 weeks.
active surveillance: Undergo active surveillance
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm B (Sunphenon)
n=2 participants at risk
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Sunphenon: Given PO
laboratory biomarker analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4 • 30 days after treatment
|
50.0%
1/2 • Number of events 3 • 30 days after treatment
|
|
Ear and labyrinth disorders
Vertigo
|
25.0%
1/4 • Number of events 1 • 30 days after treatment
|
0.00%
0/2 • 30 days after treatment
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1 • 30 days after treatment
|
0.00%
0/2 • 30 days after treatment
|
|
Renal and urinary disorders
Dysuria
|
50.0%
2/4 • Number of events 2 • 30 days after treatment
|
0.00%
0/2 • 30 days after treatment
|
Additional Information
Dr. Lee Ponsky
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place