Investigating the effects of metformin on growth factors involved in prostate cancer progression in prostate cancer patients
- Conditions
- Prostate cancerCancer - ProstateMetabolic and Endocrine - Metabolic disorders
- Registration Number
- ACTRN12615000778583
- Lead Sponsor
- Western Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 26
(1)Age 50 to 80 years
(2)ECOG equal or lower than 1
(3)Histologically confirmed prostate cancer of early or locally advanced stage, metastatic prostate cancer with bone involvement only
(4)Stable treatment with ADT in the form of a GnRH agonist for more than 6 months
(5)Able to understand and the willingness to sign a written informed consent document
(1)Visceral metastases
(2)Castrate-resistant prostate cancer (PSA progression defined as at least 3 PSA rises, measured on three successive occasions more than 1 week apart after hormonal treatment)
(3)History of confirmed type 1 or type 2 diabetes mellitus
(4)Current or prior use of metformin or other diabetes mellitus treatment within the last year
(5)Known hypersensitivity or allergy to metformin or any of its excipients
(6)Hypothalamic or pituitary disorders
(7)Other forms of malignancies excluding prostate cancer
(8)Renal (eGFR < 60mL/min/1.73m2) or hepatic impairment (bilirubin > 1.5 x upper limit normal, ALT and ALP > 2.5x upper limit normal)
(9)History of lactic acidosis
(10) Cardiac or respiratory insufficiency, alcohol abuse, severe infections that are likely to increase the risk of lactic acidosis
(11) Any medications known to cause interference with the endocrine system (excluding ADT)
(12) Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method