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Trial registered on ANZCTR


Registration number
ACTRN12615000778583
Ethics application status
Not yet submitted
Date submitted
6/07/2015
Date registered
27/07/2015
Date last updated
27/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effects of metformin on growth factors involved in prostate cancer progression in prostate cancer patients
Scientific title
Investigating the effects of metformin on growth factors involved in prostate cancer progression in prostate cancer patients
Secondary ID [1] 287047 0
Nil
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 295521 0
Condition category
Condition code
Cancer 295794 295794 0 0
Prostate
Metabolic and Endocrine 295795 295795 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metformin treatment over 6 weeks; oral tablets, dose - 500 mg twice daily for the first week, followed by 1000 mg twice daily from the second week for 5 weeks. Adherence monitored by empty tablet packet return. No washout between metformin and placebo, as study visits will be at baseline and at the end of each treatment.
Intervention code [1] 292268 0
Treatment: Drugs
Comparator / control treatment
Matching placebo, microcellulose tablets.
Control group
Placebo

Outcomes
Primary outcome [1] 295494 0
A composite primary outcome is serum IGF-1, IGF-2, IGFBPs (IGFBP-1 to 3) and bioactive IGF-1
Timepoint [1] 295494 0
Baseline and at 6 and 12 weeks
Secondary outcome [1] 315705 0
Glucose tolerance, assessed by oral glucose tolerance test
Timepoint [1] 315705 0
Baseline and at 6 and 12 weeks
Secondary outcome [2] 315779 0
Energy expenditure and substrate oxidation, assessed by indirect calorimetry
Timepoint [2] 315779 0
At baseline and 6 and 12 weeks
Secondary outcome [3] 315780 0
Body composition, assessed by bioelectrical impedance spectroscopy
Timepoint [3] 315780 0
At baseline, and at 6 and 12 weeks

Eligibility
Key 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
Minimum age
50 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be enrolled by their treating oncologists, upon when study doctor will perform screening visit and allocate for them to start metformin or placebo treatment (after concealed allocation is made by central randomisation by computer).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
NA
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation is based on a previous study that showed a significant change in IGFBP-1 levels in PCOS patients following metformin therapy. With 14 subjects, the study would have 80% power to detect a 0.42 µg/L change in IGFBP-1 levels at the 0.05 significance level. In prostate cancer patients, the effect size might be smaller compared to patients with PCOS. Thus, with 26 patients, the study will have 80% power to detect a 0.3 µg/L change in IGFBP-1. The effect of metformin therapy will be assessed using a linear mixed model analysis of the cross-over trial including a baseline covariate. Multiple comparison procedures will be used to study contrasts of interest.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4006 0
Westmead Hospital - Westmead
Recruitment hospital [2] 4007 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 9936 0
2148 - Blacktown
Recruitment postcode(s) [2] 9937 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 291604 0
University
Name [1] 291604 0
Department of Endocrinology internal funds, UWS Blacktown Clinical School.
Country [1] 291604 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Room Number 2050, Westmead Hospital, Cnr Hawkesbury & Darcy Roads
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 290275 0
University
Name [1] 290275 0
University of Western Sydney
Address [1] 290275 0
University of Western Sydney
Locked Bag 1797
Penrith, NSW 2751
Country [1] 290275 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293134 0
Western Sydney Local Healthy District
Ethics committee address [1] 293134 0
Ethics committee country [1] 293134 0
Australia
Date submitted for ethics approval [1] 293134 0
08/07/2015
Approval date [1] 293134 0
Ethics approval number [1] 293134 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58626 0
Dr Vita Birzniece
Address 58626 0
UWS Clinical School and Research Centre,
Blacktown Hospital,
Marcel Crescent,
Blacktown 2148, NSW
Country 58626 0
Australia
Phone 58626 0
+61 2 98516059
Fax 58626 0
Email 58626 0
v.birzniece@uws.edu.au
Contact person for public queries
Name 58627 0
Vita Birzniece
Address 58627 0
UWS Clinical School and Research Centre,
Blacktown Hospital,
Marcel Crescent,
Blacktown 2148, NSW
Country 58627 0
Australia
Phone 58627 0
+61 2 98516059
Fax 58627 0
Email 58627 0
v.birzniece@uws.edu.au
Contact person for scientific queries
Name 58628 0
Vita Birzniece
Address 58628 0
UWS Clinical School and Research Centre,
Blacktown Hospital,
Marcel Crescent,
Blacktown 2148, NSW
Country 58628 0
Australia
Phone 58628 0
+61 2 98516059
Fax 58628 0
Email 58628 0
v.birzniece@uws.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.