Clinical trial · Interventional
Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
Phase 1b Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
NCT03465345CI-TRIAL-00034131withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was stopped to pursue a new treatment plan with a new study.
Summary
Brief summary (as posted)
The overall goal of this study is to identify a safe dose of metformin, in combination with oligomeric procyanidin complex (OPC) for pharmacologic reduction of AGE levels in patients with prostate cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Oligomeric Procyanidin Complex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin + OPC dose escalation
- interventionNames
- Drug: Metformin
- Drug: Oligomeric Procyanidin Complex
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) of metformin in combination with OPC in PCa subjects.
- timeFrame
- 112 days
Secondary outcomes (11)
- measure
- Correlation between changes to AGE level and changes to PSA.
- timeFrame
- 112 days
- measure
- Correlation between changes to AGE level and changes to BMI.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer. 2. Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an anti-androgen, with a current testosterone level documented to be \<50ng/dL at enrollment. Subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain \<50ng/dL for the entire duration of study participation. Subjects who have undergone orchiectomy are also eligible. 3. Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows: * Hematology parameters: ANC \>1000/mcL, platelets \> 100,000/mcL, Hgb \>8.0gm/dL * Renal Function: eGFR of ≥ 45mls/min using Cockkroft and Gault formula (see appendix C). * Liver Function: Total bilirubin ≤ULN, AST and ALT \<1.5xULN, Prior radiation therapy allowed 4. Subjects may have diabetes mellitus but must not be taking metformin. 5. Able to swallow and retain oral medication 6. ECOG performance status of 0 - 2 7. Ability to sign written informed consent 8. Testosterone level \<50ng/dL at time of enrollment. 9. Age 18 or older. Exclusion Criteria: 1. Known allergy to grapes or grape seed 2. Known hypersensitivity or intolerance to metformin. 3. Any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as NYHA Class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day). 4. Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed. 5. History of receiving more than 2 classes of ADT. 6. Current use of metformin, or strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine 7. PSA doubling time of \<6 months, measured over the 3 months prior to enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.