ACTRN12615000778583Not yet recruitingPhase 4
Investigating the effects of metformin on growth factors involved in prostate cancer progression in prostate cancer patients
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 26
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (—)
- Sex
- Male
Inclusion Criteria
- •(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
Exclusion Criteria
- •(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
Investigators
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