Clinical trial · Interventional
Metformin Prostate Cancer Adjuvant Trial
Phase II Clinical Study of Effect of Metformin on Prostate Specific Antigen Doubling Time
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin Hydrochloride Extended Release 750mg | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Surgery - High Risk, Undetectable prostate-specific antigen (PSA)
- interventionNames
- Drug: Metformin Hydrochloride Extended Release 750mg
- type
- EXPERIMENTAL
- label
- Radiation - Rising PSA
- interventionNames
- Drug: Metformin Hydrochloride Extended Release 750mg
- type
- EXPERIMENTAL
- label
- Surgery - Rising PSA
- interventionNames
- Drug: Metformin Hydrochloride Extended Release 750mg
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available