N/A N=15 Other

Metformin for Rising PSA Remote Trial

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02376166 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Dec 2017

Primary outcome: Primary: Number of Participants That Completed All Telemedicine Visits — 12 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Metformin (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Male
Sponsor: Matthew Galsky
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants That Completed All Telemedicine Visits	12	—
SECONDARY Percentage of Participants With Stable PSA Levels at 6 Months as Defined by a <20% Change	7	—
SECONDARY Adherence With Metformin as Measured by Electronic Pill Adherence Monitoring	—	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1	10; 3; 0; 0; 0	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2	9; 4; 0; 0; 0	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3	11; 2; 0; 0; 0	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 4	11; 2; 0; 0; 0	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 5	5; 2; 0; 4; 2	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 6	10; 3; 0; 0; 0	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 7	11; 2; 0; 0; 0	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 8	11; 2; 0; 0; 0	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 9	11; 2; 0; 0; 0	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 10	11; 2; 0; 0; 0	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 11	8; 3; 1; 0; 1	—
SECONDARY Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 12	12; 1; 0; 0; 0	—
SECONDARY Urgency to Have a Bowel Movement Episodes	4; 4; 1; 1; 0	—
SECONDARY Increased Frequency of Bowel Movements	6; 3; 0; 1; 0	—
SECONDARY Episodes of Watery Bowel Movements	4; 3; 2; 1; 0	—
SECONDARY Episodes of Flatulence	8; 1; 1; 0; 0	—
SECONDARY Episodes of Bloating	8; 1; 1; 0; 0	—
SECONDARY Episodes of Nausea	8; 1; 0; 1; 0	—
SECONDARY Episodes of Vomiting	10; 0; 0; 0; 0	—

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).

Eligibility Criteria

Inclusion Criteria

Histologically confirmed adenocarcinoma of the prostate. (*in situations where pathology reports documenting prostate cancer are no longer available such as when the initial biopsy or prostatectomy was performed in the remote past, a documented history of prior prostate cancer and prostate cancer treatment in prior medical records will be sufficient)
Biochemical disease progression after radical prostatectomy and/or radiation therapy (external-beam radiation therapy and/or brachytherapy), and no radiographic evidence of metastases.
Men with history of radical prostatectomy are required to have baseline PSA > 0.5 ng/mL (Prior treatment with neoadjuvant, adjuvant, or salvage radiation therapy is allowed, again, with screening PSA greater than or equal to 0.5 ng/mL required for eligibility).
Men treated with primary radiation therapy are required to have baseline PSA ≥ 1.0 ng/mL above their post radiation nadir for men who were treated with primary radiation therapy (external beam and/or brachytherapy). Men who had primary radiation therapy followed by salvage prostatectomy are eligible if screening PSA is greater than or equal to 0.5 ng/mL.
Men with previous neoadjuvant adjuvant hormone therapy are eligible if testosterone level at screening is non-castrate (≥ 50 ng/dl). Men previously treated with intermittent hormonal therapy are also eligible if level of testosterone at screening is non-castrate (≥ 50 ng/dl).
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
Subjects must have normal organ as defined below:
AST(SGOT)/ALT(SGPT) less than or equal to 1.8 X institutional upper limit of normal
Serum bilirubin ≤ ULN (except for subjects with Gilbert's Disease who are eligible despite elevated serum bilirubin level)
Creatinine ≤ 1.5 mg/dL and/or creatinine clearance > 60 ml/min
English speaking

Exclusion Criteria

Concurrent use of other investigational agents or other prostate cancer therapies (e.g., androgen deprivation therapy)
Currently taking metformin, sulfonylureas, thiazolidinedione, insulin, or other antidiabetic drugs for any reason.
Known hypersensitivity or intolerance to metformin
Condition associated with increased risk of metformin-associated lactic acidosis:
New York Heart Association Class III or IV Heart Failure
Intake of 3 or more alcoholic beverages per day
Known history of lactic acidosis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02376166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.