Trial Outcomes & Findings for Metformin for Rising PSA Remote Trial (NCT NCT02376166)

NCT ID: NCT02376166

Last Updated: 2017-12-22

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-12-22

Participant Flow

Participant milestones

Measure	Metformin 850 mg PO once daily for 4 weeks 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)
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Metformin 850 mg PO once daily for 4 weeks 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)
Overall Study Adverse Event	1
Overall Study Discontinued metformin early	2

Baseline Characteristics

Metformin for Rising PSA Remote Trial

Baseline characteristics by cohort

Measure	Metformin n=15 Participants 850 mg PO once daily for 4 weeks
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Gleason Score	7 units on a scale n=5 Participants
Primary Treatment Radical prostatectomy	12 Participants n=5 Participants
Primary Treatment Radiation therapy	3 Participants n=5 Participants
Years from local therapy to study enrollment	5.9 years n=5 Participants
Baseline PSA	4.1 ng/mL n=5 Participants
One-way driving distance to study center	63.2 miles n=5 Participants
One-way driving time to study center	71 minutes n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Metformin n=15 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Number of Participants That Completed All Telemedicine Visits	12 Participants

SECONDARY outcome

Timeframe: baseline and 6 month

Percent of patients with 6-month PSA stable 20% change at 6 months as compared to baseline

Outcome measures

Measure	Metformin n=12 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Percentage of Participants With Stable PSA Levels at 6 Months as Defined by a <20% Change	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 2 patients did not complete the questionnaire

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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1 Strongly agree	10 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1 Agree	3 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1 Disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1 Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2 Strongly disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2 Strongly agree	9 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2 Agree	4 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2 Disagree	0 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3 Strongly agree	11 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3 Agree	2 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3 Disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3 Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 4 Strongly agree	11 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 4 Agree	2 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 4 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 4 Disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 4 Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 5 Strongly agree	5 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 5 Agree	2 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 5 Disagree	4 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 5 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 5 Strongly disagree	2 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 6 Strongly disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 6 Strongly agree	10 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 6 Agree	3 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 6 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 6 Disagree	0 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 7 Strongly agree	11 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 7 Agree	2 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 7 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 7 Disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 7 Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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)".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 8 Strongly agree	11 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 8 Agree	2 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 8 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 8 Disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 8 Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 9 Strongly agree	11 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 9 Agree	2 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 9 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 9 Disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 9 Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 10 Strongly agree	11 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 10 Agree	2 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 10 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 10 Disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 10 Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 11 Strongly agree	8 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 11 Agree	3 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 11 Neither agree nor disagree	1 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 11 Disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 11 Strongly disagree	1 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 12 Strongly agree	12 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 12 Agree	1 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 12 Neither agree nor disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 12 Disagree	0 Participants
Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 12 Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Urgency to Have a Bowel Movement Episodes No problem	4 episodes
Urgency to Have a Bowel Movement Episodes Very small problem	4 episodes
Urgency to Have a Bowel Movement Episodes Small problem	1 episodes
Urgency to Have a Bowel Movement Episodes Moderate problem	1 episodes
Urgency to Have a Bowel Movement Episodes Big problem	0 episodes

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Increased Frequency of Bowel Movements Moderate problem	1 episodes
Increased Frequency of Bowel Movements Big problem	0 episodes
Increased Frequency of Bowel Movements No problem	6 episodes
Increased Frequency of Bowel Movements Very small problem	3 episodes
Increased Frequency of Bowel Movements Small problem	0 episodes

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Episodes of Watery Bowel Movements No problem	4 episodes
Episodes of Watery Bowel Movements Very small problem	3 episodes
Episodes of Watery Bowel Movements Small problem	2 episodes
Episodes of Watery Bowel Movements Moderate problem	1 episodes
Episodes of Watery Bowel Movements Big problem	0 episodes

SECONDARY outcome

Timeframe: 6 months

Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 3rd reported outcome - Number of episodes of flatulence

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Episodes of Flatulence No problem	8 episodes
Episodes of Flatulence Very small problem	1 episodes
Episodes of Flatulence Small problem	1 episodes
Episodes of Flatulence Moderate problem	0 episodes
Episodes of Flatulence Big problem	0 episodes

SECONDARY outcome

Timeframe: 6 months

Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 4th reported outcome - Number of episodes of bloating

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Episodes of Bloating No problem	8 episodes
Episodes of Bloating Very small problem	1 episodes
Episodes of Bloating Small problem	1 episodes
Episodes of Bloating Moderate problem	0 episodes
Episodes of Bloating Big problem	0 episodes

SECONDARY outcome

Timeframe: 6 months

Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 5th reported outcome - Number of episodes of nausea

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Episodes of Nausea No problem	8 episodes
Episodes of Nausea Very small problem	1 episodes
Episodes of Nausea Small problem	0 episodes
Episodes of Nausea Moderate problem	1 episodes
Episodes of Nausea Big problem	0 episodes

SECONDARY outcome

Timeframe: 6 months

Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 6th reported outcome - Number of episodes of vomiting

Outcome measures

Measure	Metformin n=13 Participants 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Episodes of Vomiting No problem	10 episodes
Episodes of Vomiting Very small problem	0 episodes
Episodes of Vomiting Small problem	0 episodes
Episodes of Vomiting Moderate problem	0 episodes
Episodes of Vomiting Big problem	0 episodes

Adverse Events

Metformin

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metformin n=15 participants at risk 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
General disorders Dehydration	6.7% 1/15 • Number of events 1

Other adverse events

Measure	Metformin n=15 participants at risk 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade \> 1 toxicities)
Gastrointestinal disorders Abdominal cramps	6.7% 1/15
Gastrointestinal disorders Abdominal Pain	6.7% 1/15
General disorders Anorexia	13.3% 2/15
Gastrointestinal disorders Bloating	13.3% 2/15
Gastrointestinal disorders Consitipation	13.3% 2/15
Gastrointestinal disorders Diarrhea	80.0% 12/15
Gastrointestinal disorders Dyspepsia	6.7% 1/15
General disorders Fatigue	40.0% 6/15
Gastrointestinal disorders Flatulence	6.7% 1/15
Gastrointestinal disorders Indigestion	6.7% 1/15
Musculoskeletal and connective tissue disorders Muscle Weakness	6.7% 1/15
General disorders Nausea	6.7% 1/15
General disorders Pain	6.7% 1/15
General disorders Queasiness	6.7% 1/15
General disorders Vomiting	6.7% 1/15
General disorders Weight loss	6.7% 1/15

Additional Information

Dr. Matthew D. Galsky

Icahn School of Medicine at Mount Sinai

Phone: (212) 659-5599

Email: matthew.galsky@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place