Trial Outcomes & Findings for Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy (NCT NCT02946996)
NCT ID: NCT02946996
Last Updated: 2026-03-05
Results Overview
The primary objective is to determine if any of the test agent are able to reduce AGE levels by an average of 30% (or greater) in 50% or more of test subjects.
TERMINATED
PHASE2
41 participants
85 days
2026-03-05
Participant Flow
Overall 14 non-evaluable
Participant milestones
| Measure |
Metformin Only
Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart.
Metformin
|
OPC Only
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
OPC: OPC is a derivative of grape seed extract
|
Metformin Plus OPC
During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.
During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.
Metformin
OPC: OPC is a derivative of grape seed extract
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
16
|
13
|
|
Overall Study
COMPLETED
|
9
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
5
|
Reasons for withdrawal
| Measure |
Metformin Only
Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart.
Metformin
|
OPC Only
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
OPC: OPC is a derivative of grape seed extract
|
Metformin Plus OPC
During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.
During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.
Metformin
OPC: OPC is a derivative of grape seed extract
|
|---|---|---|---|
|
Overall Study
non-evaluable
|
3
|
6
|
5
|
Baseline Characteristics
Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Baseline characteristics by cohort
| Measure |
Metformin Only
n=12 Participants
Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart.
Metformin
|
OPC Only
n=16 Participants
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
OPC: OPC is a derivative of grape seed extract
|
Metformin Plus OPC
n=13 Participants
During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.
During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.
Metformin
OPC: OPC is a derivative of grape seed extract
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 6.1 • n=41 Participants
|
73.6 years
STANDARD_DEVIATION 5.0 • n=35 Participants
|
74.9 years
STANDARD_DEVIATION 7.8 • n=76 Participants
|
73.1 years
STANDARD_DEVIATION 6.4 • n=565 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
13 Participants
n=76 Participants
|
41 Participants
n=565 Participants
|
|
Race/Ethnicity, Customized
Black/AA
|
5 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=76 Participants
|
8 Participants
n=565 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
11 Participants
n=76 Participants
|
33 Participants
n=565 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=41 Participants
|
16 participants
n=35 Participants
|
13 participants
n=76 Participants
|
41 participants
n=565 Participants
|
PRIMARY outcome
Timeframe: 85 daysThe primary objective is to determine if any of the test agent are able to reduce AGE levels by an average of 30% (or greater) in 50% or more of test subjects.
Outcome measures
| Measure |
Metformin Only
n=8 Participants
Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart.
Metformin
|
OPC Only
n=10 Participants
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
OPC: OPC is a derivative of grape seed extract
|
Metformin Plus OPC
n=9 Participants
During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.
During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.
Metformin
OPC: OPC is a derivative of grape seed extract
|
|---|---|---|---|
|
AGE Level Reduction
|
1.49 ng/ml
Interval -1.51 to 4.52
|
0.49 ng/ml
Interval -3.32 to 1.18
|
0.8 ng/ml
Interval -0.88 to 3.09
|
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
To assess whether changes in plasma AGE levels correlate with changes in PSA levels over the 85-day study period
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: No BMI assessments were conducted, and zero participants contributed analyzable data.
This outcome was intended to evaluate whether changes in plasma AGE levels from baseline to Day 85 correlated with changes in body mass index (BMI), planned for Screening, Day 1, and Day 85. Although this measure was protocol-specified, BMI assessments were never initiated because clinical research personnel responsible for baseline and follow-up measurements departed early in the study period, before any participants reached these scheduled assessment points. After this loss of personnel, the study team no longer had qualified staff to perform BMI measurements, and retrospective collection was not possible. As a result, no BMI data were collected for any participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Dietary questionnaires were never administered; zero participants contributed analyzable data.
This outcome aimed to determine whether changes in plasma AGE levels correlated with changes in dietary intake, assessed using the NIH "Eating at America's Table Study Quick Food Scan" and the NCI "Quick Food Scan" at baseline and Day 85. Although protocol-specified, these instruments were never administered because essential study personnel who were responsible for conducting participant-reported assessments left the study before any questionnaire sessions occurred. After staff departure, the study team lacked the resources required to administer or score the diet questionnaires, and no alternative personnel were available. As a result, no dietary intake data were collected, and no analyses could be performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: No quality-of-life assessments were conducted; zero participants contributed analyzable data.
This outcome sought to evaluate whether changes in plasma AGE levels correlated with changes in quality of life, assessed with the FACT-P and AUA Symptom Index at baseline and Day 85. Although these assessments were included in the protocol, they were never initiated because the study personnel responsible for administering participant-reported questionnaires departed before any QOL data collection sessions were conducted. After the loss of staff, the study team did not have qualified personnel to administer, process, or score QOL instruments, making further collection infeasible. Consequently, no QOL data were collected for any participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
To assess the frequency and severity of adverse events associated with study drug administration, categorized by CTCAE v4 criteria.
Outcome measures
| Measure |
Metformin Only
n=12 Participants
Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart.
Metformin
|
OPC Only
n=16 Participants
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
OPC: OPC is a derivative of grape seed extract
|
Metformin Plus OPC
n=13 Participants
During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.
During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.
Metformin
OPC: OPC is a derivative of grape seed extract
|
|---|---|---|---|
|
Frequency of Adverse Events as Assessed by CTCAE v. 4
|
9 Participants
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysPopulation: Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned.
Outcome measures
Outcome data not reported
Adverse Events
Metformin Only
OPC Only
Metformin Plus OPC
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin Only
n=12 participants at risk
Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart.
Metformin
|
OPC Only
n=16 participants at risk
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
OPC: OPC is a derivative of grape seed extract
|
Metformin Plus OPC
n=13 participants at risk
During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.
During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.
Metformin
OPC: OPC is a derivative of grape seed extract
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hypertension
|
0.00%
0/12 • 85 Days
|
0.00%
0/16 • 85 Days
|
7.7%
1/13 • Number of events 1 • 85 Days
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
0.00%
0/12 • 85 Days
|
6.2%
1/16 • Number of events 1 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Renal and urinary disorders
nocturia
|
0.00%
0/12 • 85 Days
|
6.2%
1/16 • Number of events 1 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Blood and lymphatic system disorders
Hematuria
|
8.3%
1/12 • Number of events 1 • 85 Days
|
0.00%
0/16 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
8.3%
1/12 • Number of events 2 • 85 Days
|
0.00%
0/16 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Musculoskeletal and connective tissue disorders
non cardiac chest pain
|
8.3%
1/12 • Number of events 1 • 85 Days
|
0.00%
0/16 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Gastrointestinal disorders
abdominal pain
|
58.3%
7/12 • Number of events 16 • 85 Days
|
6.2%
1/16 • Number of events 1 • 85 Days
|
53.8%
7/13 • Number of events 17 • 85 Days
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • 85 Days
|
6.2%
1/16 • Number of events 1 • 85 Days
|
7.7%
1/13 • Number of events 2 • 85 Days
|
|
Injury, poisoning and procedural complications
broken tooth
|
8.3%
1/12 • Number of events 1 • 85 Days
|
0.00%
0/16 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Investigations
weight loss
|
8.3%
1/12 • Number of events 1 • 85 Days
|
0.00%
0/16 • 85 Days
|
15.4%
2/13 • Number of events 2 • 85 Days
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
8.3%
1/12 • Number of events 1 • 85 Days
|
0.00%
0/16 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
General disorders
fatigue
|
16.7%
2/12 • Number of events 2 • 85 Days
|
0.00%
0/16 • 85 Days
|
15.4%
2/13 • Number of events 2 • 85 Days
|
|
Psychiatric disorders
Libido Decreased
|
8.3%
1/12 • Number of events 1 • 85 Days
|
0.00%
0/16 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Skin and subcutaneous tissue disorders
Hot Flashes
|
25.0%
3/12 • Number of events 3 • 85 Days
|
6.2%
1/16 • Number of events 1 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
8.3%
1/12 • Number of events 1 • 85 Days
|
6.2%
1/16 • Number of events 1 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Musculoskeletal and connective tissue disorders
knee swelling
|
0.00%
0/12 • 85 Days
|
6.2%
1/16 • Number of events 1 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Musculoskeletal and connective tissue disorders
R ankle pain
|
0.00%
0/12 • 85 Days
|
6.2%
1/16 • Number of events 1 • 85 Days
|
0.00%
0/13 • 85 Days
|
|
Eye disorders
Dry Eye
|
0.00%
0/12 • 85 Days
|
6.2%
1/16 • Number of events 1 • 85 Days
|
0.00%
0/13 • 85 Days
|
Additional Information
Tricia Bentz CTO Administrative Director
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place