Metformin And Longevity

NCT02511665 | Unknown Phase 4

• 1 other identifier: METAL
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, placebo-controlled, double-blind, window of opportunity study investigating the biological mechanism of metformin in prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of the difference in expression levels of markers of the FASN/AMPK pathway pre and post treatment between the placebo and metformin arms.

  24 months

Study Arms (3)

Metformin

EXPERIMENTAL

Metformin given , 1g twice a day for 4 weeks until prostatectomy +/- one week

Drug: Metformin

Placebo

PLACEBO COMPARATOR

placebo given , 1g twice a day for 4 weeks until prostatectomy +/- one week

Drug: Placebo

PET-MRI

EXPERIMENTAL

5 patients in this arm will all receive metformin and undergo two additional PET- MRI scans, one before and one after treatment

Radiation: PET-MRI Scan

Interventions

Metformin DRUG

Given metformin

Also known as: Glucophage

Metformin

PET-MRI Scan RADIATION

Patients will under go 2 PET-MRI scans in the PET-MRI substudy arm one before treatment with metformin and one after

PET-MRI

Placebo DRUG

Given placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older and willing and able to provide signed informed consent.
• Histologically confirmed adenocarcinoma of the prostate , with a minimum maximal tumour length of greater than 6mm on core biopsy
• No previous treatment for prostate cancer (including surgery, any hormone therapy, radiotherapy and cryotherapy)
• Prostate biopsy within 8 weeks from screening which contains sufficient material for baseline molecular marker assessment at Guy's and St Thomas' NHS Foundation trust..
• Radical prostatectomy is the scheduled treatment of choice
• Eastern Cooperative Oncology Group (ECOG) Performance status less than or equal to 0 or 1.
• Adequate organ function, defined as follows:
• Haemoglobin \>10.0g/dL
• Absolute neutrophil count \>1.5x109/L
• Platelet count \>100x109/L
• Renal function, eGFR \>60ml/min (calculated by Cockcroft Gault)
• AST and/or ALT \<2.5 x ULN
• Total Bilirubin \<1.5 x ULN
• Able to swallow the drug and comply with study requirements.

You may not qualify if:

• Patients with a current or historical diagnosis of type one or two Diabetes and/or have ever received metformin
• Patients with hypersensitivity to any of the components of Metformin or placebo tablet
• History of or conditions associated with lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), and conditions associated with hypoxaemia
• Patients with chronic liver disease, severe cardiovascular impairment, cardiac failure, recent myocardial infarction, severe peripheral vascular disease or renal impairment (eGFR \<60ml/min as measured by Cockcroft Gault)
• Patients with acute severe disorders, for example infections with fever, pancreatitis, trauma, dehydration or reduced diet (\<1000kcal or 4200kJ per day)
• Other active malignancy over the last five years that has required systemic therapy, excluding:
• Adjuvant therapy in the curative setting
• Non-melanoma skin cancer
• Superficial transitional cell carcinoma (CIS-T1)
• Current enrolment in an investigational drug or device study or participation in such a study within 30 days of signing consent.
• Any subjects who is able to father a child and does not agree to use barrier protection, in the form of a condom ,for the duration of the trial and for 16 weeks after the last study drug administration.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Sarah Rudman, MBBS BSc PhD

  Guy's and St Thomas NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 30, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

GB (1)