Clinical trial · Interventional
Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
NCT02946996CI-TRIAL-00104805terminatedPhase 2Results postedClinicalTrials.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): Investigator retired from clinical practice prior to enrollment goal being met.
Summary
Brief summary (as posted)
The purpose of this study is to look at the effect that the study drug OPC has on 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 |
| OPC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Metformin Only
- description
- Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart.
- interventionNames
- Drug: Metformin
- type
- EXPERIMENTAL
- label
- OPC Only
- description
- Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
- interventionNames
- Other: OPC
- type
- EXPERIMENTAL
- label
- Metformin plus OPC
- description
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. Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed. 4. 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 Cockgroft and Gault formula (see appendix C). * Liver Function: Total bilirubin ≤ULN, AST and ALT \<1.5xULN 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 Exclusion Criteria 1. Known allergy to grapes or grape seed 2. History of receiving more than 2 classes of ADT. 3. Current use of 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. See section 4.7 for more details.
References
Publications (0)
Data not yet available
No reference posted for this study.