Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT01215032
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* History of bilateral orchiectomies or ongoing treatment with a GnRH agonist for GnRH antagonist
* Disease progression according to PSA Working Group 2
* Minimum starting PSA (Prostate Specific Antigen) level of 2.0 ng/mL
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Exclusion Criteria:
* Symptomatic metastases
* Receiving any other agents for the treatment of prostate cancer except gonadotropin releasing hormone (GnRH) agonist or antagonist within the last 30 days
* Received any investigational cancer treatment agents within the last 30 days
* Prior treatment with docetaxel
* History of diabetes requiring drug therapy
* Current treatment with metformin or metformin treatment within the last year
* History of allergic reaction to metformin
* Have uncontrolled intercurrent illness including, but not limited to ongoing or unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Serum creatinine 1.5mg/dL or greater
* Hepatic impairment
* Need for ongoing treatment with cimetidine
* History of a different malignancy except for the following circumstances: Individuals with a history of other malignancies are eligible of they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: basal cell or squamous cell carcinoma of the skin
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT01215032
Study Brief:
Protocol Section:
NCT01215032