TerminatedPhase 3

Metformin in Patients Initiating ADT as Prevention and Intervention of Metabolic Syndrome

Stopped: Manufacturer discontinued the production of study drugs.

Canada166 participantsStarted 2018-07-12

Plain-language summary

This is a multi-centre, double-blind, randomized phase III trial comparing metformin to placebo in patients with advanced prostate cancer starting (or have recently started) androgen deprivation therapy (ADT).

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Pathologically confirmed adenocarcinoma of the prostate
. Eligible for initiating androgen deprivation therapy with either:
. (Neo-)Adjuvant therapy for localized prostate cancer that is planned continuously for at least 9 months; or
. Metastatic disease: or
. Biochemical recurrence of prostate cancer as defined as EITHER:
. Serum testosterone \> 5nmol/L (except for participants who have already started androgen deprivation therapy (within no more than 45 days of commencing study treatment)).
. The choice of androgen deprivation therapy is at the investigators discretion but must include at minimum the use of luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy. The addition of other hormonal agents (e.g., non-steroidal antiandrogens, abiraterone, enzalutamide, apalutamide) is allowed.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 18 months of study treatment

Timeframe: 18 months

Trial details

NCT IDNCT03031821

SponsorCanadian Urologic Oncology Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-24

View on ClinicalTrials.gov More Prostate Cancer trials

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Pathologically confirmed adenocarcinoma of the prostate
. Eligible for initiating androgen deprivation therapy with either:
. (Neo-)Adjuvant therapy for localized prostate cancer that is planned continuously for at least 9 months; or
. Metastatic disease: or
. Biochemical recurrence of prostate cancer as defined as EITHER:
. Serum testosterone \> 5nmol/L (except for participants who have already started androgen deprivation therapy (within no more than 45 days of commencing study treatment)).
. The choice of androgen deprivation therapy is at the investigators discretion but must include at minimum the use of luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy. The addition of other hormonal agents (e.g., non-steroidal antiandrogens, abiraterone, enzalutamide, apalutamide) is allowed.

Metformin in Patients Initiating ADT as Prevention and Intervention of Metabolic Syndrome

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Metformin in Patients Initiating ADT as Prevention and Intervention of Metabolic Syndrome

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria