Metformin for Rising PSA Remote Trial (M-RePoRT)

November 27, 2017 updated by: Matthew Galsky

M-RePoRT: Metformin - Rising PSA Remote Trial

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Men with an isolated PSA recurrence after local therapy are an ideal population for the evaluation of novel therapies given the minimal disease burden, generally indolent natural history, and patients' preference to avoid the adverse effects of androgen deprivation therapy. Metformin has shown anti-prostate cancer activity in preclinical models and cohort studies. Metformin, a biguanide oral antihyperglycemic agent, abrogates hyperinsulinemia in individuals with and without diabetes and has shown promising anti-prostate cancer activity in preclinical models, epidemiologic studies, and retrospective cohorts. Several epidemiologic/retrospective studies have shown that metformin has a positive impact on overall survival among men with prostate cancer.

These nonclinical and clinical studies have led to calls for prospective studies of metformin in patients with prostate cancer. This is a pilot telemedicine study of metformin in patients with a rising PSA ("biochemical recurrence") after definitive local therapy for prostate cancer.

The current study is supported by the following rationale:

  • A large proportion of clinical trials close prematurely due to poor accrual.
  • Geographic inaccessibility is a barrier to clinical trial participation.
  • Metformin is a safe and inexpensive medication that has demonstrated anti-prostate cancer activity in nonclinical and epidemiologic studies. Importantly, metformin has been shown to be safe in non-diabetic patients (e.g., patients with polycystic ovary disease) and does not cause hypoglycemia.
  • Use of novel technologies may facilitate clinical trial accrual and minimize the burden of participation for patients. Ultimately, these approaches may also decrease the cost of drug development and increase the pace of progress.

In the absence of prohibitive toxicities or disease progression (defined in 4.4), patients may continue treatment for the 6-month study period. This study will include a baseline visit for study enrollment at Mount Sinai. The remainder of the visits will be telemedicine visits conducted using secure video conferencing.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Metformin
850 mg PO once daily for 4 weeks
Drug: Metformin
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)
Other Names:
  • Glucophage

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants That Completed All Telemedicine Visits
Time Frame: 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Stable PSA Levels at 6 Months as Defined by a <20% Change
Time Frame: baseline and 6 month
Percent of patients with 6-month PSA stable 20% change at 6 months as compared to baseline
baseline and 6 month
Adherence With Metformin as Measured by Electronic Pill Adherence Monitoring
Time Frame: 6 months
Adherence with metformin as measured by electronic pill adherence monitoring. Patients were provided with an electronic medication dispenser/medication adherence monitoring device. The device provided audible and visual reminders to proceed with drug dosing and was equipped with a cellular modem that registers a signal to a cloud-based database each time a patient accessed his or her study medication. However, the size and shape of the metformin pills caused the device to malfunction frequently, which led patients to access the pills from the device manually; the data, therefore, could not be used for analysis.
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I would participate in a clinical trial in the future".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I would participate in a telemedicine clinical trial in the future".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "The time commitment required for participation in this trial was not overly burdensome".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 4
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "Participation in this trial did not disrupt my work or other activities".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 5
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I found it easy to use the telemonitoring tablet computer".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 6
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "This telemedicine approach eases the travel burden for participation in clinical trials for patients".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 7
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "This telemedicine approach eases the financial burden of participation in clinical trials for patients".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 8
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "My local physician was adequately informed about my participation in this trial (if applicable)".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 9
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I felt I was monitored sufficiently closely while enrolled in this trial".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 10
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I would recommend participation in a telemedicine clinical trial to other patients".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 11
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I would participate in a clinical trial where the entire trial was conducted remotely without requiring any visits to the study center".
6 months
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 12
Time Frame: 6 months
Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I felt that I was able to communicate well with the study team, even though most contact was through the tablet computer video instead of in person".
6 months
Urgency to Have a Bowel Movement Episodes
Time Frame: 6 months
Quality of LIfe as measured by a modified RAND 36-Item Health Survey. Ist reported outcome - Number of episodes of urgency to have a bowel movement
6 months
Increased Frequency of Bowel Movements
Time Frame: 6 months
Quality of LIfe as measured by a modified RAND 36-Item Health Survey. Ist reported outcome - Number of episodes of Increased frequency of bowel movements
6 months
Episodes of Watery Bowel Movements
Time Frame: 6 months
Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 2st reported outcome - Number of episodes of watery bowel movements
6 months
Episodes of Flatulence
Time Frame: 6 months
Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 3rd reported outcome - Number of episodes of flatulence
6 months
Episodes of Bloating
Time Frame: 6 months
Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 4th reported outcome - Number of episodes of bloating
6 months
Episodes of Nausea
Time Frame: 6 months
Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 5th reported outcome - Number of episodes of nausea
6 months
Episodes of Vomiting
Time Frame: 6 months
Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 6th reported outcome - Number of episodes of vomiting
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Matthew Galsky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCO 14-0472

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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