NCT02420652

Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy

A Phase 2 Randomized Discontinuation Trial in Patients With Hormone-Dependent Rising Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer Evaluating the Synergy of Metformin Plus Aspirin (PRIMA Trial)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well metformin hydrochloride and aspirin work in treating patients with hormone-dependent prostate cancer that has progressed after surgery or radiation therapy. Metformin hydrochloride and aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving metformin hydrochloride and aspirin together can slow the growth of prostate cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the effect of metformin (metformin hydrochloride) and aspirin on the change in prostate-specific antigen (PSA) progression in men with rising PSA after definitive therapy for localized prostate cancer and stable disease during a run-in period with the study regimen. SECONDARY OBJECTIVES: I. To determine the feasibility and safety of administering metformin and aspirin. II. To determine the effect of metformin and aspirin on PSA levels and the serum obesity-related prostate cancer (PCa) biomarkers (insulin, insulin-like growth factor \[IGF\]-1, interleukin \[IL\]-1beta, IL-6, and tumor necrosis factor \[TNF\]-alpha). OUTLINE: RUN-IN STAGE: Patients receive metformin hydrochloride orally (PO) twice daily (BID) and aspirin PO once daily (QD) for 4 months. Patients with disease progression (PSA increase of \> 50% and minimum of 2ng/ml rise in PSA) come off study. Patients achieving disease response (\>25% decline in PSA) continue to receive study agents in the absence of disease progression or unacceptable disease. Patients with stable disease continue on to the randomized study regimen. RANDOMIZATION STAGE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive metformin hydrochloride PO BID and aspirin PO QD for 6 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive metformin hydrochloride placebo PO BID and aspirin placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12-16 weeks for 1 year.

Conditions

• Recurrent Prostate Carcinoma
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer

Interventions

Type	Name	Description
DRUG	Aspirin	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Metformin Hydrochloride	Given PO
OTHER	Placebo	Given metformin hydrochloride placebo PO
OTHER	Placebo	Given aspirin placebo PO

Timeline

• Start date: 2015-06-23
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2015-04-20
• Last updated: 2023-02-08
• Results posted: 2023-02-08

Locations

1 site across 1 country: United States