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: 2025-05-09
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
85 days
Results posted on
2025-05-09
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=5 Participants
|
73.6 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
74.9 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
73.1 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/AA
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
13 participants
n=5 Participants
|
41 participants
n=4 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 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysToxicities will be tabulated per arm by type and grade and the proportion of patients with grade 3, grade 4 or an SAE will be estimated with a 90% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 85 daysOutcome measures
Outcome data not reported
Adverse Events
Metformin Only
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
OPC Only
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Metformin Plus OPC
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
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
|
|---|---|---|---|
|
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
|
|
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
|
Additional Information
Tricia Bentz CTO Administrative Director
Medical University of South Carolina
Phone: 8437921415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place