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Metformin for Prostate Cancer and Metabolic Syndrome (PRIME Trial)
PRIME Trial Summary
This trial is comparing the effects of metformin to a placebo in patients with advanced prostate cancer who are starting or have recently started ADT.
- Prostate Cancer
- Metabolic Syndrome
PRIME Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT02002221PRIME Trial Design
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- 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.
- Group 1: Metformin
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
For what purpose is Metformin most commonly prescribed?
"Metformin is a medication that is regularly prescribed to patients with type 1 diabetes mellitus, polycystic ovary syndrome, and diabetic ketoacidosis."
What similar research has been conducted using Metformin?
"Metformin was first studied in clinical trials by George Washington University in 2002. To date, 1260 have completed similar experiments. Right now, there are 180 active studies involving metformin with a high concentration of these being located in Toronto, Canada."
Are there any vacancies in this study for new participants?
"Yes, the clinicaltrials.gov website contains information suggesting that this trial is still actively recruiting patients. This particular study was first posted on July 12th, 2018 and was last updated on July 11th, 2022. They are looking for a total of 300 participants spread out across 15 different locations."
Are there any sites outside of Canada conducting this research?
"This research is being conducted at 15 different hospitals, including the Princess Margaret Cancer Centre (Princess Margaret Hospital) in Toronto, the Centre Hospitalier de L'Universite de Montreal (CHUM) in Montreal, and Northeast Cancer Centre in Sudbury."
What is the Metformin drug's official government rating?
"There is prior clinical data supporting Metformin's safety, so it received a score of 3."
Could you give an estimate of how many people are involved in this clinical trial?
"To run this clinical study, we require 300 individuals who meet the pre-specified inclusion criteria. These participants can come from various locations such as Princess Margaret Cancer Centre (Princess Margaret Hospital) in Toronto, Ontario and Centre Hospitalier de L'Universite de Montreal (CHUM) in Montreal, Quebec."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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