Metformin for Rising PSA Remote Trial

NCT02376166 | Completed Results DMC

• 1 other identifier: GCO 14-0472
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Completed All Telemedicine Visits

  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).

  6 months

Secondary Outcomes (21)

• Percentage of Participants With Stable PSA Levels at 6 Months as Defined by a <20% Change

  baseline and 6 month

• Adherence With Metformin as Measured by Electronic Pill Adherence Monitoring

  6 months

• Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1

  6 months

• Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2

  6 months

• Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3

  6 months

Study Arms (1)

Metformin

EXPERIMENTAL

850 mg PO once daily for 4 weeks

Drug: Metformin

Interventions

Metformin DRUG

850 mg PO twice daily for the remainder of the study period (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)

Also known as: Glucophage

Metformin

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthew Galsky: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Galsky MD, Shahin M, Jia R, Shaffer DR, Gimpel-Tetra K, Tsao CK, Baker C, Leiter A, Holland J, Sablinski T, Mehrazin R, Sfakianos JP, Acon P, Oh WK. Telemedicine-Enabled Clinical Trial of Metformin in Patients With Prostate Cancer. JCO Clin Cancer Inform. 2017 Nov;1:1-10. doi: 10.1200/CCI.17.00044.

  PMID: 30657386 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

One limitation was the need for a single onsite enrollment visit, which likely still represents a significant geographic barrier to trial accrual.

Results Point of Contact

• Title: Dr. Matthew D. Galsky
• Organization: Icahn School of Medicine at Mount Sinai

matthew.galsky@mssm.edu

(212) 659-5599

Study Officials

• Matthew Galsky, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Medicine, Hematology and Medical Oncology

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 3, 2015
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 22, 2017
• Results First Posted: December 22, 2017

Record last verified: 2017-11

Locations

US (1)