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Clinical Trials/ACTRN12615000778583
ACTRN12615000778583Not yet recruitingPhase 4

Investigating the effects of metformin on growth factors involved in prostate cancer progression in prostate cancer patients

Western Sydney Local Health District0 sites26 target enrollmentStarted: July 27, 2015Last updated:
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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