NCT02176161

Metformin Prostate Cancer Adjuvant Trial

Phase II Clinical Study of Effect of Metformin on Prostate Specific Antigen Doubling Time

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II clinical study to determine if Metformin can increase Prostate Specific Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary treatment with radiation, or surgical patients that are at high risk for recurrence based on surgical pathology. Men with confirmed prostate cancer and rising serum PSA levels will receive Metformin and will be monitored for PSA response and disease progression.

Detailed description

Prostate cancer patients who have received treatment with radiation therapy or surgery, who have indicators of high-risk disease will be administered 750mg Metformin Extended Release twice per day for a period of 9 months. Metformin is an FDA-approved drug that is prescribed to treat high blood sugar levels in patients with Type 2 Diabetes. To track prostate cancer response in study participants, investigators will obtain prostate specific antigen (PSA) levels every three months for the duration of the trial.

Conditions

• Prostate Cancer
• Prostate Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride Extended Release 750mg	Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.

Timeline

• Start date: 2014-06-01
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2014-06-26
• Last updated: 2022-10-18
• Results posted: 2022-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study