Metformin for Rising PSA Remote Trial

Study Summary

Clinical trials are critical to informing the care of patients with cancer. However, only 3-5% of patients with cancer enroll in clinical trials. Poor accrual to trials has major implications with regards to the pace of progress, the cost of clinical cancer research, and the generalizability of results. The investigators have recently shown in an analysis of 7,776 cancer clinical trials registered on clinicaltrials.gov that approximately 20% of cancer clinical trials fail to complete enrollment at all; the most often cited reason was poor accrual. Prior research has identified barriers to cancer clinical trial accrual that can be generally categorized in the domains of availability, awareness, and acceptance. Much attention has been paid to the barriers involvement awareness and acceptance - however, trial availability is likely a "rate limiting step". This pilot study is the first in a series of planned steps to attempt to shift the current paradigm of "bringing patients to trials" to "bringing trials to patients." With the integration of telemedicine visits, the investigators aim to decrease the burden of participation for patients, begin to address geographic barriers, and ultimately improve trial accrual. In this study, men with biochemically recurrent prostate cancer (a rising PSA after definitive local therapy) will receive the antidiabetic drug, metformin. Patients will require a single on-site visit for study enrollment. The remainder of the 6 month study will be conducted via a HIPPA secure telemonitoring system (monthly visits conducted via telemedicine with tablet computers provided to each patients).

Primary Outcome

Feasibility will be defined as completion of all telemedicine visits by \> 2/3 of enrolled patients (unless treatment discontinued early for toxicity or disease progression).

Interventions

• DRUG Metformin