Trial Outcomes & Findings for Metformin Prostate Cancer Adjuvant Trial (NCT NCT02176161)

NCT ID: NCT02176161

Last Updated: 2022-10-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 59 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2022-10-18

Participant Flow

Participant milestones

Measure	Surgery - High Risk, Undetectable Prostate-specific Antigen (PSA) Metformin Hydrochloride Extended Release 750mg: Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.	Radiation - Rising PSA Metformin Hydrochloride Extended Release 750mg: Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.	Surgery - Rising PSA Metformin Hydrochloride Extended Release 750mg: Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Overall Study STARTED	15	18	26
Overall Study COMPLETED	15	18	26
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metformin Prostate Cancer Adjuvant Trial

Baseline characteristics by cohort

Measure	Surgery - High Risk, Undetectable Prostate-specific Antigen (PSA) n=15 Participants Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.	Radiation - Rising PSA n=18 Participants Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.	Surgery - Rising PSA n=26 Participants Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.	Total n=59 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants 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	15 Participants n=5 Participants	18 Participants n=7 Participants	26 Participants n=5 Participants	59 Participants n=4 Participants
Age, Continuous	73.02 years STANDARD_DEVIATION 6.86 • n=5 Participants	72.95 years STANDARD_DEVIATION 6.86 • n=7 Participants	72.97 years STANDARD_DEVIATION 6.98 • n=5 Participants	72.97 years STANDARD_DEVIATION 6.81 • n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants	37 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants	45 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	18 participants n=7 Participants	26 participants n=5 Participants	59 participants n=4 Participants

PRIMARY outcome

Timeframe: 9 months

Outcome measures

Measure	Surgery - High Risk, Undetectable Prostate-specific Antigen (PSA) n=18 Participants Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.	Radiation - Rising PSA n=15 Participants Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.	Surgery - Rising PSA n=26 Participants Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Mean Prostate Specific Antigen (PSA) Level	0.61 ng/mL Standard Deviation 0.633	0.70 ng/mL Standard Deviation 0.67	0.54 ng/mL Standard Deviation 0.66

Adverse Events

Surgery - High Risk, Undetectable Prostate-specific Antigen (PSA)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Radiation - Rising PSA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surgery - Rising PSA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Surgery - High Risk, Undetectable Prostate-specific Antigen (PSA) n=18 participants at risk Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.	Radiation - Rising PSA n=15 participants at risk Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.	Surgery - Rising PSA n=26 participants at risk Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Gastrointestinal disorders Diarrhea	5.6% 1/18 • 9 months Adverse events were monitored on a monthly basis	0.00% 0/15 • 9 months Adverse events were monitored on a monthly basis	3.8% 1/26 • 9 months Adverse events were monitored on a monthly basis
Infections and infestations Tick Bite	5.6% 1/18 • 9 months Adverse events were monitored on a monthly basis	0.00% 0/15 • 9 months Adverse events were monitored on a monthly basis	0.00% 0/26 • 9 months Adverse events were monitored on a monthly basis
Blood and lymphatic system disorders Left basal ganglia hemorrhage	5.6% 1/18 • 9 months Adverse events were monitored on a monthly basis	0.00% 0/15 • 9 months Adverse events were monitored on a monthly basis	0.00% 0/26 • 9 months Adverse events were monitored on a monthly basis
Musculoskeletal and connective tissue disorders right inguinal hernia	5.6% 1/18 • 9 months Adverse events were monitored on a monthly basis	0.00% 0/15 • 9 months Adverse events were monitored on a monthly basis	0.00% 0/26 • 9 months Adverse events were monitored on a monthly basis
Infections and infestations Urinary tract infection	5.6% 1/18 • 9 months Adverse events were monitored on a monthly basis	0.00% 0/15 • 9 months Adverse events were monitored on a monthly basis	0.00% 0/26 • 9 months Adverse events were monitored on a monthly basis

Additional Information

Aaron Katz, MD

NYU Langone Health

Phone: 516-535-1900

Email: Aaron.Katz@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place