Pilot study to evaluate the prognostic and metabolic effects of metformin during treatment of metastatic prostate cancer with androgen deprivation therapy

Phase 2

Recruiting

• Conditions: Metastatic prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12614001054606
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to progression of disease defined as biochemical, radiographic or clinical progression[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)<br><br>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. ]

Secondary Outcome Measures

Name	Time	Method
Changes to metabolic parameters including fasting insulin by blood test , fasting glucose by blood test, body mass index, and serum biomarkers (Leptin, adiponectin, ghrelin)[Every 6 weeks for 42 weeks and at week 54 (end-of-study visit)];Molecular changes to the circulating tumour cells. <br>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.[Every 12 weeks for 36 weeks and at week 54 (End-of-Study Visit)]