Trial Outcomes & Findings for Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy (NCT NCT02420652)
NCT ID: NCT02420652
Last Updated: 2023-02-08
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
6 months
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Arm I (Metformin Hydrochloride, Aspirin)
Patients receive metformin hydrochloride PO BID and aspirin PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
Aspirin: Given PO
Laboratory Biomarker Analysis: Correlative studies
Metformin Hydrochloride: Given PO
|
Arm II (Metformin Hydrochloride Placebo, Aspirin Placebo)
Patients receive metformin hydrochloride placebo PO BID and aspirin placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given metformin hydrochloride placebo PO
Placebo: Given aspirin placebo PO
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
9
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy
Baseline characteristics by cohort
| Measure |
Arm I (Metformin Hydrochloride, Aspirin)
n=18 Participants
Patients receive metformin hydrochloride placebo PO BID and aspirin placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
|
Arm II (Metformin Hydrochloride Placebo, Aspirin Placebo)
n=9 Participants
Metformin 1500 mg/Day and Aspirin 81 mg/Day x 4 cycles. Participants receive metformin hydrochloride PO BID and aspirin PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
n=93 Participants
|
67.8 years
n=4 Participants
|
67.8 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
9 participants
n=4 Participants
|
27 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Arm I (Metformin Hydrochloride, Aspirin)
n=8 Participants
Patients receive metformin hydrochloride PO BID and aspirin PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
Aspirin: Given PO
Laboratory Biomarker Analysis: Correlative studies
Metformin Hydrochloride: Given PO
|
Arm II (Metformin Hydrochloride Placebo, Aspirin Placebo)
n=5 Participants
Patients receive metformin hydrochloride placebo PO BID and aspirin placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given metformin hydrochloride placebo PO
Placebo: Given aspirin placebo PO
|
|---|---|---|
|
Measure of PSA ng/mL Rates After Six Months of Metformin Hydrochloride and Aspirin or Placebo Therapy in Patients Who Have Received Four Months of Open Label Treatment
|
2.02 ng/mL
Standard Deviation 0.77
|
1.43 ng/mL
Standard Deviation 0.54
|
Adverse Events
Arm I (Metformin Hydrochloride, Aspirin)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (Metformin Hydrochloride Placebo, Aspirin Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Biren Saraiya, MD
Rutgers Cancer Institute of New Jersey
Phone: 732-235-3360
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place