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Biguanide
Metformin for Prostate Cancer and Metabolic Syndrome (PRIME Trial)
Phase 3
Waitlist Available
Research Sponsored by Canadian Urologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 years
Awards & highlights
Pivotal Trial
Summary
This trial tests if metformin can help men with advanced prostate cancer on ADT by reducing the risk and severity of metabolic syndrome. Metformin helps control blood sugar by improving how the body uses insulin. Metformin is the most used drug for type 2 diabetes and has shown potential anti-cancer effects in various studies.
Eligible Conditions
- Metabolic Syndrome
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Therapeutic procedure
Secondary study objectives
Health-related Quality of Life assessed at 18 months of follow-up.
Proportion of participants who meet the criteria of elevated blood pressure assessed at 18 months of follow-up.
Proportion of participants who meet the criteria of elevated fasting blood glucose levels assessed at 18 months of follow-up.
+7 moreOther study objectives
Abdominal girth assessed at 18 months of follow-up.
Biochemical progression-free survival
Body mass assessed at 18 months of follow-up.
+16 moreSide effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
Metformin 850 mg PO OD X 30 days, then 850mg PO BID for a total of 18 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo Oral Tablet
1 tablet (850mg) PO OD X 30 days, then 850mg PO BID for a total of 18 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Find a Location
Who is running the clinical trial?
BC Cancer FoundationOTHER
18 Previous Clinical Trials
8,391 Total Patients Enrolled
British Columbia Cancer AgencyOTHER
175 Previous Clinical Trials
94,060 Total Patients Enrolled
Canadian Urologic Oncology GroupLead Sponsor
7 Previous Clinical Trials
749 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been receiving ongoing treatment for localized prostate cancer for at least 9 months, have metastatic disease, or have an increasing PSA level after previous surgery for prostate cancer.Your PSA level is higher than 2ng/mL after receiving radiotherapy.You have not received hormone therapy for prostate cancer within the last year, unless you started it within the last 45 days before starting the study.You have been diagnosed with diabetes according to the Canadian Diabetes Association criteria within 28 days before enrolling in the study.You have a history of lactic acidosis or conditions that make you more likely to develop lactic acidosis, like kidney problems, liver disease, alcohol abuse, severe infection, or heart failure.If you are receiving androgen deprivation therapy, you must have already decided if you will take it continuously or with breaks before joining the study.You have had other types of cancer, except for non-melanoma skin cancer or solid tumors that have been treated and have not come back for at least 5 years.You have been diagnosed with a specific type of prostate cancer called adenocarcinoma.Your prostate cancer is coming back, as shown by a rising PSA level after surgery or radiotherapy.Your testosterone levels are higher than 5nmol/L, unless you have already started a specific hormone therapy within 45 days before starting the study treatment.The participant must be receiving a certain type of hormone therapy that includes a specific drug. They can also receive other hormone medications if needed.Your testosterone level is higher than 5nmol/L, unless you have recently started treatment to lower it.You are able to start hormone therapy for prostate cancer, either before or after surgery, and are planning to continue it for at least 9 months.You are currently taking or have taken metformin or other diabetic medications in the past 28 days.If you are taking androgen deprivation therapy, you must decide if you will take it continuously or on and off before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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