A common diabetes drug may protect against hormone therapy's metabolic side effects
NCT ID NCT03031821
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether metformin, a standard diabetes medication, can prevent or reverse metabolic syndrome in men with prostate cancer who are starting androgen deprivation therapy (ADT). Metabolic syndrome—a cluster of conditions like high blood sugar, high blood pressure, and excess belly fat—is a common side effect of ADT. The study randomly assigns 166 participants to receive either metformin or a placebo for 18 months, and measures how many develop metabolic syndrome by the end of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin
- What this could lead to
- If it works, metformin could become a simple way to reduce metabolic side effects from hormone therapy in prostate cancer patients.
- What could go wrong
- This is a mid-stage trial with 166 participants, so results may not apply to all patients. Metformin can cause gastrointestinal side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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166 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Nov 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Participants must fulfill all the following criteria to be eligible for admission to the study: 1. Pathologically confirmed adenocarcinoma of the prostate 2. Eligible for initiating androgen deprivation therapy with either: 1. (Neo-)Adjuvant therapy for localized prostate cancer that is planned continuously for at least 9 months; or 2. Metastatic disease: or 3. Biochemical recurrence of prostate cancer as defined as EITHER: * A rising PSA after prior curative intent surgical therapy (e.g., prostatectomy with or without adjuvant/ salvage radiotherapy). Since an absolute consensus for this value has not been established, if a rising PSA has been documented by at least two PSA values at least 2 weeks apart, the criteria for biochemical recurrence are deemed to have been met. Or, * PSA ≥ 2ng/mL above their nadir if previously treated with definitive radiotherapy 3. Serum testosterone \> 5nmol/L (except for participants who have already started androgen deprivation therapy (within no more than 45 days of commencing study treatment)). 4. 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. 5. The androgen deprivation therapy undertaken can be intermittent or continuous, but the treatment intent must be declared prior to randomization. 6. Participant is able (e.g., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to registration/randomization. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the participant ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the participant ineligible. 7. Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate. 8. Participant must be accessible for treatment and follow up. Participants registered on this trial must be treated and followed at the participating centre. Investigators must assure themselves that the participants registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. 9. Protocol treatment is to begin within 7 working days of participant randomization. Exclusion Criteria Participants who fulfill any of the following criteria are not eligible for admission to the study: 1. Prior androgen deprivation therapy within 12 months of enrolment (except for participants who have started androgen deprivation therapy within 45 days of commencing study treatment) * Prior androgen deprivation therapy associated with definitive treatment is permitted, if it has been completed at least 12 months prior to enrolment (e.g., last injection or tablet taken 12 months prior to study enrolment) 2. Participant that meet ≥ 1 of the Canadian Diabetes Association criteria for the diagnosis of diabetes within 28 days of enrolment: * Fasting plasma glucose of ≥ 7mmol/L; or * HbA1C ≥ 6.5%. 3. Participant currently taking metformin (or other diabetic medications) or who have taken metformin (or other diabetic medications) within 28 days of enrolment. 4. History of lactic acidosis or conditions that predispose to lactic acidosis: * Impaired Renal Function (eGFR \<45mL/ minute/ 1.73 m\^2); or * Liver disease, including alcoholic liver disease, as demonstrated by any of the following parameters: 1. AST \> 1.8 x the upper limit of normal 2. ALT \> 1.8 x the upper limit of normal 3. Alkaline Phosphatase \>2x the upper limit of normal 4. Serum total bilirubin \> 1.5x the upper limit of normal (except for participant with Gilbert's Disease who are eligible despite elevated serum bilirubin levels). * Alcohol abuse (habitual intake of ≥ 3 alcoholic beverages per day) sufficient to cause hepatic toxicity; or * Severe infection; or * Congestive heart failure (defined as New York Heart Association Class III or IV functional status). 5. Participant with a history of other invasive malignancies, except adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BC Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
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CHU de Quebec - Universite Laval
Laval, Quebec, Canada
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Cancer Care Manitoba
Winnepeg, Manitoba, R3E 0V9, Canada
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Central Newfoundland Regional Health Centre
Grand Falls-Windsor, Newfoundland and Labrador, A2A 2E1, Canada
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Centre Hospitalier de L'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9, Canada
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Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec / Centre hospitalier régional
Trois-Rivières, Quebec, G8Z 3R9, Canada
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Ciusss-Chus
Sherbrooke, Quebec, J1H 5N4, Canada
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Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
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Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 8V6, Canada
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Horizon Health Network
Saint John, New Brunswick, E3B 4R3, Canada
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McGill University Health Center-Cedar Cancer Center
Montreal, Quebec, H4A 3J1, Canada
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Northeast Cancer Centre
Greater Sudbury, Ontario, P3E 5J1, Canada
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Princess Margaret Cancer Centre (Princess Margaret Hospital)
Toronto, Ontario, M5G 2M9, Canada
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Sunnybrook Research Institue
Toronto, Ontario, M4N 3M5, Canada
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Tom Baker Cancer Centre
Calgary, Alberta, T2S 3C3, Canada
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Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?