Prostate CancerPhase 2NCT01733836
Prostate Cancer Active Surveillance Metformin Trial
A Phase 2 study testing Metformin in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
To determine whether the use of metformin in patients with low-risk prostate cancer can delay progression to clinically significant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent
- Men >= 18 years of age, and less than 80
- Men with biopsy proven, low-risk, localized prostate cancer (as defined below)
- Men choosing expectant management as primary treatment for prostate cancer
- Diagnostic biopsy performed within 4 months of screening visit
- Gleason score ≤ 6 in 3 cores or less with no Gleason pattern 4, less than 50% of any core involved in cancer
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- Clinical stage T1c-T2a (Initial diagnosis of T1a/T1b obtained during a TURP is not allowed)
- Serum PSA ≤10 ng/mL
- Life expectancy greater than 5 years
- Normal kidney and hepatic function as defined by the following criteria:
- Total bilirubin less than 1.5 X institutional upper limit of normal (ULN)
- AST (SGOT)/ALT(SGPT) less than 1.5 X institutional ULN
- Alkaline phosphatase less than 2 X institutional ULN
- Creatinine less than 1.4 X institutional ULN
- Able to swallow and retain oral medication
- No exposure to metformin within 12 months of randomization
- No known hypersensitivity or intolerance to metformin hydrochloride
- No condition associated with increased risk of metformin hydrochloride-associated lactic acidosis (e.g., congestive heart failure defined as NYHA class III or IV function status, history of acidosis of any type, or habitual intake of ≥ 3 alcoholic beverages per day, or age greater than 80)
- English fluency allowing for patient reported outcomes completion
Who cannot join
- Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues)
- Diabetes including type 1 diabetes. Patients with known type 2 diabetes are eligible provided they have not been on metformin during the previous 12 months and are not on any other pharmacological agents.
- Concurrent or previous use of anabolic steroids or drugs with anti androgenic properties including 5-ARIs (dutasteride and finasteride)
- Prostate volume greater than 80 cc. (as per TRUS biopsy report)
- Prostatic surgery or procedure within 3 months of screening visit
- Severe BPH symptoms (IPSS ≥25, or ≥20 if already on α-blocker therapy)
Show all 11Show fewer
- Other malignancies, with the exception of adequately treated nonmelanoma skin cancer, NMIBC or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
- Planned or concurrent participation in other interventional randomized trials including exercise
- The presence of any other coexistent medical condition that in the opinion of the investigator would have the potential to significantly limit adherence to medication, or ability to absorb the medication including but not limited to psychiatric conditions, malabsorption syndromes or severe ischemic heart disease
- Known hypersensitivity or intolerance to metformin
- Concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1 or their receptors, or PI3K inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double Blind Placebo Controlled Single Institution Phase 2 Study of Metformin in Patients Undergoing Active Surveillance for Prostate Cancer.
To determine whether the use of metformin in patients with low-risk prostate cancer can delay progression to clinically significant prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Metformin, placebo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | 850mg BID Receives: Drug: Metformin |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Clinical Outcome - Inhibition of Prostate Cancer
To assess the role of metformin on the inhibition of low-risk localized prostate cancer progression in men undergoing active surveillance for prostate cancer.
Measured: 18 months
Primary Scientific Endpoint - ki67 index
To assess the effect of metformin on the cell cycle proliferation indices (ki67 index).
Measured: 18 months
Secondary outcomes (4)
Secondary Endpoint - Cell Cycle Proliferation (CCP) Score
To assess the effect of metformin on the cell cycle proliferation indices (CCP score)
Measured: 18 months
Secondary Endpoint - Mechanism of Action
To assess the effect of metformin on systemic and local signalling axes and morphometric measurements relevant to its mechanism of action.
Measured: 18 months
Secondary endpoint - Quality of Life
To assess the impact of metformin on Quality of Life (QoL) indices.
Measured: 18 months
Secondary Endpoint - Prognostic Panel
To determine the utility of a prognostic panel of 31 cell cycle progression genes recently validated in prostate cancer.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: The reason for this decision is that this study is being merged with a larger multi-centre study using the same agent in the same population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733836
- Sponsor's protocol ID
- MAS_001
- Status last verified
- May 2013
- First submitted
- 20 Nov 2012
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roy S, Malone S, Grimes S, Morgan SC. Impact of Concomitant Medications on Biochemical Outcome in Localised Prostate Cancer Treated with Radiotherapy and Androgen Deprivation Therapy. Clin Oncol (R Coll Radiol). 2021 Mar;33(3):181-190. doi: 10.1016/j.clon.2020.09.005. Epub 2020 Sep 29.
PubMed 32994091
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Placebo Controlled Single Institution Phase 2 Study of Metformin in Patients Undergoing Active Surveillance for Prostate Cancer.
- ClinicalTrials.gov ID
- NCT01733836
- Acronym / sponsor ID
- MAS_001
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The reason for this decision is that this study is being merged with a larger multi-centre study using the same agent in the same population.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether the use of metformin in patients with low-risk prostate cancer can delay progression to clinically significant prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin850mg BID |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Willing and able to provide informed consent
- Men >= 18 years of age, and less than 80
- Men with biopsy proven, low-risk, localized prostate cancer (as defined below)
- Men choosing expectant management as primary treatment for prostate cancer
- Diagnostic biopsy performed within 4 months of screening visit
Key exclusion criteria (11 listed)
- Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues)
- Diabetes including type 1 diabetes. Patients with known type 2 diabetes are eligible provided they have not been on metformin during the previous 12 months and are not on any other pharmacological agents.
- Concurrent or previous use of anabolic steroids or drugs with anti androgenic properties including 5-ARIs (dutasteride and finasteride)
- Prostate volume greater than 80 cc. (as per TRUS biopsy report)
- Prostatic surgery or procedure within 3 months of screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | Metformin |
| placebo | Drug | Placebo |
Primary outcome
Primary Clinical Outcome - Inhibition of Prostate Cancer
Time frame: 18 months
To assess the role of metformin on the inhibition of low-risk localized prostate cancer progression in men undergoing active surveillance for prostate cancer.
Primary Scientific Endpoint - ki67 index
Time frame: 18 months
To assess the effect of metformin on the cell cycle proliferation indices (ki67 index).
4 secondary outcomes
Secondary Endpoint - Cell Cycle Proliferation (CCP) Score
Time frame: 18 months
Secondary Endpoint - Mechanism of Action
Time frame: 18 months
Secondary endpoint - Quality of Life
Time frame: 18 months
Secondary Endpoint - Prognostic Panel
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Derived from this study: PubMed 32994091Roy S, Malone S, Grimes S, Morgan SC. Impact of Concomitant Medications on Biochemical Outcome in Localised Prostate Cancer Treated with Radiotherapy and Androgen Deprivation Therapy. Clin Oncol (R Coll Radiol). 2021 Mar;33(3):181-190. doi: 10.1016/j.clon.2020.09.005. Epub 2020 Sep 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Clinical Outcome - Inhibition of Prostate Cancer (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2013.