Prostate CancerPhase 2NCT02176161
Metformin Prostate Cancer Adjuvant Trial
A Phase 2 study testing Metformin Hydrochloride Extended Release 750mg in people with Prostate Cancer and Prostate Cancer Recurrent, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a Phase II clinical study to determine if Metformin can increase Prostate Specific Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary treatment with radiation, or surgical patients that are at high risk for recurrence based on surgical pathology. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Recurrent
- What is being tested?
- Metformin Hydrochloride Extended Release 750mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 21 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male > 18 years of age
- Biopsy confirmed adenocarcinoma of the prostate
- Able to swallow and retain oral medication
- Hemoglobin A1C <7.0%
- Able and willing to participate in the full 12 months of the study
- Able to understand instructions related to study procedures
- Able to read and write English
Who cannot join
- Metastatic Prostate Cancer
- Prostate Specific Antigen Doubling Time < 6 months
- Prior Chemotherapy, hormonal therapy, oral glucocorticoid therapy, Gonadotropin-releasing hormone analogue therapy
- Current or previous use of 5α-reductase inhibitors, antiandrogen drugs, metformin, oral or injectable diabetes drug
- Diagnosis of Type 1 Diabetes Mellitus
- Known hypersensitivity to metformin
Show all 14Show fewer
- any condition associated with increased risk of metformin associated lactic acidosis
- participation in any investigational or marketed drug trial within 30 days prior to screening or during study period
- any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
- history of megaloblastic anemia
- abnormal liver function test (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or serum creatinine above upper limit of normal)
- history of other malignancies, with the exception of adequately treated non-melanoma skin cancer, stage 1 melanoma, non-muscle invasive bladder cancer, or other solid tumors curatively treated with no evidence of disease for at least 5 years
- history or current evidence of substance abuse within 12 months of screening
- history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or post an additional risk to the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: Phase II Clinical Study of Effect of Metformin on Prostate Specific Antigen Doubling Time
This is a Phase II clinical study to determine if Metformin can increase Prostate Specific Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary treatment with radiation, or surgical patients that are at high risk for recurrence based on surgical pathology. Men with confirmed prostate cancer and rising serum PSA levels will receive Metformin and will be monitored for PSA response and disease progression.
Read the detailed description
Prostate cancer patients who have received treatment with radiation therapy or surgery, who have indicators of high-risk disease will be administered 750mg Metformin Extended Release twice per day for a period of 9 months. Metformin is an FDA-approved drug that is prescribed to treat high blood sugar levels in patients with Type 2 Diabetes. To track prostate cancer response in study participants, investigators will obtain prostate specific antigen (PSA) levels every three months for the duration of the trial.
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent
- Being tested
- Metformin Hydrochloride Extended Release 750mg
- Keywords
- Prostate Cancer, Prostate Cancer Recurrent
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride Extended Release 750mgDrug
Also called Glucophage XR, Glumetza XR
Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Surgery - High Risk, Undetectable prostate-specific antigen (PSA) | Experimental | Not described Receives: Drug: Metformin Hydrochloride Extended Release 750mg |
| Radiation - Rising PSA | Experimental | Not described Receives: Drug: Metformin Hydrochloride Extended Release 750mg |
| Surgery - Rising PSA | Experimental | Not described Receives: Drug: Metformin Hydrochloride Extended Release 750mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Prostate Specific Antigen (PSA) Level
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron E Katz, MD, Principal investigator, NYU Winthrop Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176161
- Sponsor's protocol ID
- WUH 14015
- Other IDs
- 18-01662
- Status last verified
- Sep 2022
- First submitted
- 24 Jun 2014
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Effect of Metformin on Prostate Specific Antigen Doubling Time
- ClinicalTrials.gov ID
- NCT02176161
- Acronym / sponsor ID
- WUH 14015
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent
- Keywords
- Prostate Cancer, Prostate Cancer Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 18 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II clinical study to determine if Metformin can increase Prostate Specific Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary treatment with radiation, or surgical patients that are at high risk for recurrence based on surgical pathology. Men with confirmed prostate cancer and rising serum PSA levels will receive Metformin and will be monitored for PSA response and disease progression.
Detailed description
Prostate cancer patients who have received treatment with radiation therapy or surgery, who have indicators of high-risk disease will be administered 750mg Metformin Extended Release twice per day for a period of 9 months. Metformin is an FDA-approved drug that is prescribed to treat high blood sugar levels in patients with Type 2 Diabetes. To track prostate cancer response in study participants, investigators will obtain prostate specific antigen (PSA) levels every three months for the duration of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgery - High Risk, Undetectable prostate-specific antigen (PSA) | Experimental | Drug: Metformin Hydrochloride Extended Release 750mg |
| Radiation - Rising PSA | Experimental | Drug: Metformin Hydrochloride Extended Release 750mg |
| Surgery - Rising PSA | Experimental | Drug: Metformin Hydrochloride Extended Release 750mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male > 18 years of age
- Biopsy confirmed adenocarcinoma of the prostate
- Able to swallow and retain oral medication
- Hemoglobin A1C <7.0%
- Able and willing to participate in the full 12 months of the study
Key exclusion criteria (14 listed)
- Metastatic Prostate Cancer
- Prostate Specific Antigen Doubling Time < 6 months
- Prior Chemotherapy, hormonal therapy, oral glucocorticoid therapy, Gonadotropin-releasing hormone analogue therapy
- Current or previous use of 5α-reductase inhibitors, antiandrogen drugs, metformin, oral or injectable diabetes drug
- Diagnosis of Type 1 Diabetes Mellitus
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 Hydrochloride Extended Release 750mgAlso: Glucophage XR, Glumetza XRMetformin Hydrochloride Extended Release 750mg twice per day for 9 months. | Drug | Radiation - Rising PSA, Surgery - High Risk, Undetectable prostate-specific antigen (PSA), Surgery - Rising PSA |
Primary outcome
Mean Prostate Specific Antigen (PSA) Level
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Aaron E Katz, MD principal investigator
NYU Winthrop Hospital
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 Hydrochloride Extended Release 750mg in people with Prostate Cancer and Prostate Cancer Recurrent, run by NYU Langone Health at 1 site in United States.
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 7 inclusion and 14 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: finished, as of the sponsor's last update on 18 Oct 2022. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 18 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Prostate Specific Antigen (PSA) Level (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2022.