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Trial registered on ANZCTR
Registration number
ACTRN12614001054606
Ethics application status
Approved
Date submitted
20/08/2014
Date registered
2/10/2014
Date last updated
30/03/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Pilot study to evaluate the prognostic and metabolic effects of metformin during treatment of metastatic prostate cancer with androgen deprivation therapy
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Scientific title
Pilot study to evaluate the prognostic and metabolic effects of metformin during treatment of metastatic prostate cancer with androgen deprivation therapy
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Secondary ID [1]
284884
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Nil
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Universal Trial Number (UTN)
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Trial acronym
ADMET – ADjuvant METformin in metastatic prostate cancer with ADT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic prostate cancer
292322
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Condition category
Condition code
Cancer
292658
292658
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a two-arm study. Both Arm 1 and Arm 2 will be receiving androgen deprivation therapy (ADT). The ADT used is a combined androgen blockade with luteinizing hormone releasing hormone (LHRH) agonist (45mg EligardTrademark) and AR antagonist (50mg Cosudex/bicalutamide) for the first 4 weeks as per standard of care. After that, EligardTrademark will continue as monotherapy 6 monthly unless clinically indicated for complete androgen blockade. At 12 weeks into ADT, participants will receive 1500mg metformin (3x500mg daily, with meals) or placebo depending on the treatment arm allocated after randomization.
Metformin or Placebo tablets will be dispensed every 12 weeks. Participants will need to return the unused tablets to the research team before or after each dispensing for drug accountability purpose. Moreover, participants will have 6 weekly medical review.
Arm 1
Metformin hydrochloride 500mg tablet
Dosage: 1500mg daily
Duration: 30 weeks
Mode of administration: Oral
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Intervention code [1]
289693
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Treatment: Drugs
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Comparator / control treatment
Arm 2
Placebo
Duration: 30 weeks
Mode of administration: Oral
The placebo are biconvex, film coated tablets. They have everything the same as the Metformin tablet except without active ingredient.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Time to progression of disease defined as biochemical, radiographic or clinical progression
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Assessment method [1]
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Timepoint [1]
292505
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Prostate specific antigen and 6 weekly clincial review will be used to determine biochemical and clinical progression: every 6 weeks for 42 weeks and at week 54 (end-of-study visit)
CT scan and bone scan will be used to determine radiographic progression: if clinically indicated. Radiographically, Prostate Cancer Working Group (PCWG) 2 criteria will be used.
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Secondary outcome [1]
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Changes to metabolic parameters including fasting insulin by blood test , fasting glucose by blood test, body mass index, and serum biomarkers (Leptin, adiponectin, ghrelin)
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Assessment method [1]
309114
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Timepoint [1]
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Every 6 weeks for 42 weeks and at week 54 (end-of-study visit)
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Secondary outcome [2]
310671
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Molecular changes to the circulating tumour cells.
Circulating tumour cells will be isolated using Stemcell Technology RosetteSep. The isolated cells will be lysed. The chages will be assessed by real-time polymerase chain reaction.
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Assessment method [2]
310671
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Timepoint [2]
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Every 12 weeks for 36 weeks and at week 54 (End-of-Study Visit)
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Eligibility
Key inclusion criteria
1. Age above 18 years
2. Competent to understand information and provide written informed consent
3. Metastatic prostate adenocarcinoma defined by radiological diagnosis (TNM staging), PSA greater or than equal to 20 in the presence of tissue diagnosis or abnormal prostate examination, PSA recurrence post surgery or radiotherapy
4. No prior chemotherapy for prostate cancer
5. Not on insulin control medications [Insulin, oral hypoglycaemic agents, systemic corticosteroid of any dosage, atypical antipsychotic drugs of any dose]
6. Adequate renal function (Creatinine equal to 177mmol/L, GFR greater than 30 mls/min)
7. Adequate hepatic function (Bilirubin must be equal to 1.5 x upper limit of normal range, ALT and ALP must be equal to 2.5 x upper limit of normal)
8. Life expectancy greater than 6 months
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Known brain metastasis
2. Malignant disease other than prostate cancer at the time of enrolment, apart from completely treated non-melanomatous skin malignancy
3. Prior chemotherapy for prostate cancer
4. Prior primary radiotherapy within 6 weeks
5. Previously treated with ketoconazole for greater than 7 days
6. Prior systemic treatment with an azole drug within 4 weeks
7. Prior antiandrogen treatment within 6 weeks
8. History of lactic acidosis
9. History of pituitary or adrenal dysfunction
10. Cardiac (heart failure NYHA class II or greater, acute myocardial infarct, unstable angina, arterial-thromboembolic event within past 6 months) or respiratory insufficiency (active pulmonary embolism, severe chronic obstructive pulmondary disease), severe liver failure (cirrhosis with a Child-Pugh level of B or greater), severe infection that is likely to increase the risk of lactic acidosis
11. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
12. History of pituitary or adrenal dysfunction
13. Participants will be discharged from the study if unable to tolerate metformin due to adverse reactions or develop medical conditions such as renal failure or diabetes requiring additional agents other than metformin
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment: Consecutive patients with metastatic prostate cancer suitable for trial who has been referred to service areas of Princess Alexandra Hospital
Randomization: Central randomisation by computer to treatment groups
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by computer
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
Nil
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
8/09/2014
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Actual
8/09/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [2]
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Epworth Richmond - Richmond
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Recruitment hospital [3]
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Gold Coast Hospital - Southport
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Recruitment postcode(s) [1]
8377
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
9684
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3121 - Richmond
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Funding & Sponsors
Funding source category [1]
289508
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Hospital
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Name [1]
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2014 Princess Alexandra Hospital Research Support Scheme Grants
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Address [1]
289508
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PA Research Foundation, Princess Alexandra Hospital, Centres for Health Research, Translational Research Institute, 37 Kent Street, Woolloongabba QLD 4102
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Country [1]
289508
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Australia
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Funding source category [2]
289808
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Commercial sector/Industry
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Name [2]
289808
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Tolmar Australia Pty Ltd
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Address [2]
289808
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Building 2, Leve 2, Suite 4, 20 Bridge Street
PYMBLE NSW 2073
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Country [2]
289808
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Australia
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Primary sponsor type
University
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Name
Queensland University of Technology
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Address
2, George Street, Brisbane, QLD 4122, Australia
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Country
Australia
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Secondary sponsor category [1]
288189
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None
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Name [1]
288189
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Address [1]
288189
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Country [1]
288189
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291253
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Metro South Health service District Human Research Ethics Committee
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Ethics committee address [1]
291253
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Princess Alexandra Hospital, Centres for Health Research, Level 7, Translational Research Institute, 37 Kent Street, Woolloongabba QLD 4102
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Ethics committee country [1]
291253
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Australia
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Date submitted for ethics approval [1]
291253
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Approval date [1]
291253
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19/05/2014
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Ethics approval number [1]
291253
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EC00167
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Ethics committee name [2]
291254
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Queensland University of Technology Human Research Ethics Committee
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Ethics committee address [2]
291254
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Research Ethics Unit, Office of Research, Level 4, 88 Musk Ave, QUT Kelvin Grove QLD 4059
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Ethics committee country [2]
291254
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Australia
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Date submitted for ethics approval [2]
291254
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Approval date [2]
291254
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29/07/2014
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Ethics approval number [2]
291254
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EC00171
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Ethics committee name [3]
292842
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Epworth HealthCare Human Research Ethics Committee
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Ethics committee address [3]
292842
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89 Bridge Road, Richmond VIC 3121
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Ethics committee country [3]
292842
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Australia
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Date submitted for ethics approval [3]
292842
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Approval date [3]
292842
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24/04/2015
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Ethics approval number [3]
292842
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EC00217
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Summary
Brief summary
This study will investigate the effects of combining metformin with androgen deprivation therapy (ADT) in men with metastatic prostate cancer.
You may be eligible to join this study if you are male, aged 18 years or above and have been diagnosed with metastatic prostate adenocarcinoma, for which you have not received any ADT.
Study details
Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will take 3 x 500mg oral tablets of metformin hydrochloride daily for 30 weeks, whilst participants in the other group will take 3 oral tablets of placebo (inactive treatment) daily for 30 weeks.
Participants will be followed-up every 6 weeks for 54 weeks, in order to determine metabolic and tumour responses and tumour progression.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Colleen Nelson
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Address
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Australian Prostate Cancer Research Centre – Queensland
Level 1, Building 1, Princess Alexandra Hospital, 199 Ipswich Road, Brisbane QLD 4102
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Country
49410
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Australia
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Phone
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+61 7 3176 7443
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Fax
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Email
49410
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[email protected]
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Contact person for public queries
Name
49411
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Prof Colleen Nelson
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Address
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Australian Prostate Cancer Research Centre – Queensland
Level 1, Building 1, Princess Alexandra Hospital, 199 Ipswich Road, Brisbane QLD 4102
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Country
49411
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Australia
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Phone
49411
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+61 7 3176 7443
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Fax
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Email
49411
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[email protected]
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Contact person for scientific queries
Name
49412
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Prof Colleen Nelson
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Address
49412
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Australian Prostate Cancer Research Centre – Queensland
Level 1, Building 1, Princess Alexandra Hospital, 199 Ipswich Road, Brisbane QLD 4102
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Country
49412
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Australia
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Phone
49412
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+61 7 3176 7443
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Fax
49412
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Email
49412
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[email protected]
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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.
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