Prostate Cancer, Prostate Cancer Recurrent
Conditions
Keywords
Prostate Cancer, Prostate Cancer Recurrent
Brief 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. 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.
Interventions
DRUGMetformin Hydrochloride Extended Release 750mg
Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Prostate Specific Antigen (PSA) Level | 9 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgery - High Risk, Undetectable Prostate-specific Antigen (PSA) Metformin Hydrochloride Extended Release 750mg twice per day for 9 months. | 15 |
| Radiation - Rising PSA Metformin Hydrochloride Extended Release 750mg twice per day for 9 months. | 18 |
| Surgery - Rising PSA Metformin Hydrochloride Extended Release 750mg twice per day for 9 months. | 26 |
| Total | 59 |
Baseline characteristics
| Characteristic | Surgery - High Risk, Undetectable Prostate-specific Antigen (PSA) | Total | Surgery - Rising PSA | Radiation - Rising PSA |
|---|---|---|---|---|
| Age, Continuous | 73.02 years STANDARD_DEVIATION 6.86 | 72.97 years STANDARD_DEVIATION 6.81 | 72.97 years STANDARD_DEVIATION 6.98 | 72.95 years STANDARD_DEVIATION 6.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 37 Participants | 17 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 20 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 14 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) White | 11 Participants | 45 Participants | 21 Participants | 13 Participants |
| Region of Enrollment United States | 15 participants | 59 participants | 26 participants | 18 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 15 Participants | 59 Participants | 26 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 15 | 0 / 26 |
| other Total, other adverse events | 5 / 18 | 0 / 15 | 1 / 26 |
| serious Total, serious adverse events | 0 / 18 | 0 / 15 | 0 / 26 |
Outcome results
Primary
Mean Prostate Specific Antigen (PSA) Level
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surgery - High Risk, Undetectable Prostate-specific Antigen (PSA) | Mean Prostate Specific Antigen (PSA) Level | 0.61 ng/mL | Standard Deviation 0.633 |
| Radiation - Rising PSA | Mean Prostate Specific Antigen (PSA) Level | 0.70 ng/mL | Standard Deviation 0.67 |
| Surgery - Rising PSA | Mean Prostate Specific Antigen (PSA) Level | 0.54 ng/mL | Standard Deviation 0.66 |